Ministry of Industry and Trade of the Russian Federation order no. 2905 of August 28, 2020

ON APPROVAL OF THE PROCEDURE FOR CONDUCTING TESTING OF REFERENCE MATERIALS OR MEASURING INSTRUMENTS FOR TYPE APPROVAL PURPOSES, THE PROCEDURE FOR APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS, FOR MAKING AMENDMENTS TO THE INFORMATION THEREON, THE PROCEDURE FOR ISSUING CERTIFICATES OF APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS, THE FORMS OF CERTIFICATES OF APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS, REQUIREMENTS FOR MARKS OF APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS, AND THE PROCEDURE FOR THEIR APPLICATION

(as amended by Order of the Ministry of Industry and Trade of the Russian Federation No. 3388 of August 12, 2022)

In accordance with Part 7 of Article 12 of Federal Law No. 102-FZ of June 26, 2008 "On Ensuring the Uniformity of Measurements" (Collected Legislation of the Russian Federation, 2008, No. 26, Art. 3021; 2019, No. 52, Art. 7814) and subclauses 5.2.18.5, 5.2.18.6, 5.2.18.7, 5.2.18(36) of Clause 5 of the Regulation on the Ministry of Industry and Trade of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 438 of June 5, 2008 (Collected Legislation of the Russian Federation, 2008, No. 24, Art. 2867; 2020, No. 39, Art. 6038), I hereby order:

1. Approve:

• the procedure for conducting testing of reference materials or measuring instruments for type approval purposes in accordance with Appendix No. 1 to this Order;
• the procedure for approval of the type of reference materials or type of measuring instruments, and for making amendments to the information thereon in accordance with Appendix No. 2 to this Order;
• the procedure for issuing certificates of approval of the type of reference materials or type of measuring instruments in accordance with Appendix No. 3 to this Order;
• the forms of certificates of approval of the type of reference materials or type of measuring instruments in accordance with Appendix No. 4 to this Order;
• the requirements for marks of approval of the type of reference materials or type of measuring instruments and the procedure for their application in accordance with Appendix No. 5 to this Order.

2. Declare invalid the following orders of the Ministry of Industry and Trade of the Russian Federation:

• No. 1081 of November 30, 2009 "On Approval of the Procedure for Conducting Testing of Reference Materials or Measuring Instruments for Type Approval Purposes, the Procedure for Approval of the Type of Reference Materials or Type of Measuring Instruments, the Procedure for Issuing Certificates of Approval of the Type of Reference Materials or Type of Measuring Instruments, Establishing and Changing the Validity Period of Such Certificates and the Verification Interval for Measuring Instruments, Requirements for Marks of Approval of the Type of Reference Materials or Type of Measuring Instruments, and the Procedure for Their Application" (registered with the Ministry of Justice of the Russian Federation on December 25, 2009, Registration No. 15866);
• No. 1326 of September 30, 2011 "On Amendments to the Procedure for Approval of the Type of Reference Materials or Type of Measuring Instruments, the Procedure for Issuing Certificates of Approval of the Type of Reference Materials or Type of Measuring Instruments, Establishing and Changing the Validity Period of Such Certificates and the Verification Interval for Measuring Instruments, approved by Order of the Ministry of Industry and Trade of Russia No. 1081 of November 30, 2009" (registered with the Ministry of Justice of the Russian Federation on October 19, 2011, Registration No. 22084);
• No. 3249 of August 20, 2018 "On Amendments to the Procedure for Conducting Testing of Reference Materials or Measuring Instruments for Type Approval Purposes, approved by Order of the Ministry of Industry and Trade of the Russian Federation No. 1081 of November 30, 2009 'On Approval of the Procedure for Conducting Testing of Reference Materials or Measuring Instruments for Type Approval Purposes, the Procedure for Approval of the Type of Reference Materials or Type of Measuring Instruments, the Procedure for Issuing Certificates of Approval of the Type of Reference Materials or Type of Measuring Instruments, Establishing and Changing the Validity Period of Such Certificates and the Verification Interval for Measuring Instruments, Requirements for Marks of Approval of the Type of Reference Materials or Type of Measuring Instruments, and the Procedure for Their Application'" (registered with the Ministry of Justice of the Russian Federation on November 6, 2018, Registration No. 52608);
• No. 164 of February 3, 2015 "On Approval of the Form of Certificates of Approval of the Type of Reference Materials or Type of Measuring Instruments" (registered with the Ministry of Justice of the Russian Federation on April 17, 2015, Registration No. 36900);
• No. 3251 of August 20, 2018 "On Amendments to the Forms of Certificates of Approval of the Type of Reference Materials or Type of Measuring Instruments, approved by Order of the Ministry of Industry and Trade of the Russian Federation No. 164 of February 3, 2015 'On Approval of the Form of Certificates of Approval of the Type of Reference Materials or Type of Measuring Instruments'" (registered with the Ministry of Justice of the Russian Federation on November 6, 2018, Registration No. 52606).

3. Entrust supervision of the execution of this Order to the Deputy Minister of Industry and Trade of the Russian Federation, A.S. Besprozvannykh.
4. This Order shall enter into force on January 1, 2021, and shall remain in effect until January 1, 2027.

Acting Minister
G.M. KADYROVA

Appendix No. 1
to the Order of the Ministry of Industry and Trade of Russia
No. 2905 of August 28, 2020

PROCEDURE FOR CONDUCTING TESTING OF REFERENCE MATERIALS OR MEASURING INSTRUMENTS FOR TYPE APPROVAL PURPOSES

I. General Provisions

1. This Procedure establishes the rules for conducting testing of reference materials or measuring instruments for type approval purposes (hereinafter - testing of reference materials or measuring instruments, testing of reference materials, testing of measuring instruments), as well as for making amendments to the information on approved types of reference materials or measuring instruments.
2. Testing of reference materials or measuring instruments shall be conducted taking into account the nature of their production:

• production of reference materials and manufacture of measuring instruments carried out on an ongoing basis, as well as production of reference materials or manufacture of measuring instruments in periodically recurring batches (hereinafter - serial production);
• production of reference materials or manufacture of measuring instruments of a specific type, carried out once, with repeated production (manufacture) not being envisaged (hereinafter - single-unit production).

Testing of measuring instruments used in the field of defense and state security shall be conducted taking into account the specific features provided for in Clause 9 of the Regulation on the Specific Features of Ensuring the Uniformity of Measurements in the Implementation of Activities in the Field of Defense and Security of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 780 of October 2, 2009 "On the Specific Features of Ensuring the Uniformity of Measurements in the Implementation of Activities in the Field of Defense and Security of the Russian Federation" (Collected Legislation of the Russian Federation, 2009, No. 41, Art. 4766; 2017, No. 24, Art. 3532).

Testing of reference materials or measuring instruments used in the field of atomic energy use shall be conducted in accordance with the procedure for conducting testing of reference materials or measuring instruments in the field of atomic energy use for type approval purposes, provided for in Clause 6 of the Regulation on the Specific Features of Ensuring the Uniformity of Measurements in the Implementation of Activities in the Field of Atomic Energy Use, approved by Resolution of the Government of the Russian Federation No. 1488 of December 30, 2012.

3. Testing of reference materials or measuring instruments shall be conducted on the basis of an application for testing of reference materials or measuring instruments.

An application for testing of reference materials or measuring instruments of serial production shall be submitted by legal entities and individual entrepreneurs engaged in the release of reference materials or measuring instruments into circulation on the market (hereinafter respectively - release from production, manufacturers of measuring instruments, producers of reference materials, applicants for testing of reference materials or measuring instruments of serial production) or by legal entities and individual entrepreneurs authorized by them (hereinafter - authorized representatives).

An application for testing of reference materials or measuring instruments of single-unit production shall be submitted by legal entities and individual entrepreneurs engaged in the development of reference materials or measuring instruments, release of reference materials or measuring instruments from production, import into the territory of the Russian Federation, sale on the territory of the Russian Federation of reference materials or measuring instruments, use of reference materials or measuring instruments (hereinafter - applicants for testing of reference materials or measuring instruments of single-unit production), or by authorized representatives.

4. Testing of reference materials or measuring instruments shall be conducted by legal entities accredited in accordance with the legislation of the Russian Federation on accreditation in the national accreditation system in the field of ensuring the uniformity of measurements for performing testing of reference materials or measuring instruments (hereinafter - the Tester), in accordance with their scopes of accreditation.

Information on the scope of accreditation of the Tester shall be submitted by applicants for testing of reference materials or measuring instruments of serial production and applicants for testing of reference materials or measuring instruments of single-unit production (hereinafter - the Applicant) by the federal executive body exercising accreditation in the field of ensuring the uniformity of measurements from the register of accredited persons in accordance with Federal Law No. 412-FZ of December 28, 2013 "On Accreditation in the National Accreditation System" (Collected Legislation of the Russian Federation, 2013, No. 52, Art. 6977; 2018, No. 31, Art. 4851) (hereinafter - the register of accredited persons, Federal Law No. 412-FZ).

5. Work and (or) services for conducting testing of reference materials or measuring instruments in accordance with Part 2 of Article 26 of Federal Law No. 102-FZ of June 26, 2008 "On Ensuring the Uniformity of Measurements" (Collected Legislation of the Russian Federation, 2008, No. 26, Art. 3021; 2019, No. 52, Art. 7814) (hereinafter - Federal Law No. 102-FZ) shall be paid for by the Applicant in accordance with the terms of concluded agreements (contracts) for conducting testing of reference materials or measuring instruments, unless otherwise provided for by the legislation of the Russian Federation.

II. Testing of Reference Materials for Type Approval Purposes

6. The Applicant shall send to the Tester an application for conducting testing of reference materials on paper or in the form of an electronic document in accordance with Clause 11.1 of Article 2 of Federal Law No. 149-FZ of July 27, 2006 "On Information, Information Technologies and Protection of Information" (Collected Legislation of the Russian Federation, 2006, No. 31, Art. 3448; 2010, No. 31, Art. 4196) (hereinafter - electronic document).

In the event that the Tester is determined as a result of procurement in accordance with Federal Law No. 44-FZ of April 5, 2013 "On the Contract System in the Sphere of Procurement of Goods, Works, Services for State and Municipal Needs" (Collected Legislation of the Russian Federation, 2013, No. 14, Art. 1652; 2020, No. 24, Art. 3754) (hereinafter - Federal Law No. 44-FZ), the submission of the application for conducting testing of reference materials to the Tester shall be carried out after the signing of the agreement (contract) for conducting testing of reference materials.

7. The application for conducting testing of reference materials must contain the following information:

• name, location and address of the legal entity, or the surname, first name and patronymic (if any), address of registration at the place of stay or place of residence of the individual and address of activity for the individual entrepreneur acting as the Applicant;
• information on the document confirming the authority of the Applicant to submit the application (order of appointment as head, power of attorney);
• information on the producers of reference materials (names, locations and addresses of legal entities and (or) surnames, first names, patronymics (if any), address of registration at the place of stay or place of residence of individuals and addresses of their places of activity for individual entrepreneurs) submitting reference materials for testing (for reference materials of serial production);
• name and designation of the type of reference material;
• information on the purpose and scope of application of the reference material, indicating safety measures when working with the material of the reference material, and on permitting documents (on their availability);
• nature of production of the reference material (serial or single-unit);
• information on documents (list of documents) establishing the requirements for reference materials submitted for testing (technical specification for the development of the reference material, technical specifications for the reference material);
• declared metrological and technical characteristics of the reference material;
• information on the development and availability of a scientific and technical report of the producer of reference materials on the development of the reference material, containing a description and selection of the material of the reference material corresponding to its purpose, justification for the selection of metrological and technical characteristics, shelf life of the reference material, description of conditions of use, storage, transportation (if there are special transportation conditions) (hereinafter - the scientific and technical report on the development of the reference material), or on its absence.

In the application for conducting testing of reference materials, the Applicant shall indicate:

• batch number of the reference material (for reference materials of serial production);
• numbers of the specimens submitted for testing (for reference materials of single-unit production).

8. The Applicant shall submit together with the application for conducting testing of reference materials the accompanying documents for the reference materials (passport of the reference material or certificate of the reference material - for reference materials imported into the territory of the Russian Federation).

Accompanying documents for reference materials imported into the territory of the Russian Federation must be prepared in Russian.

9. The Tester shall review the application for conducting testing of reference materials within 10 working days from the date of its receipt (in the event that the Tester is not determined as a result of procurement in accordance with Federal Law No. 44-FZ).

For the purpose of conducting testing of reference materials, the Tester shall send to the Applicant a draft agreement (contract) for conducting testing of reference materials for type approval purposes, including verification of the results of testing of reference materials.

In the event of the impossibility of conducting testing of reference materials due to the absence of legal grounds for performing the work (lack of accreditation) and (or) the technical capability of the Tester (malfunction or scheduled maintenance on the Tester's equipment) and (or) non-compliance of the submitted application for conducting testing of reference materials with the requirements of Clause 7 of this Procedure (absence of information specified in the application, its incompleteness or inconsistency), the Tester shall notify the Applicant in writing thereof, stating the reasons for refusal to conduct testing.

10. The Tester, after signing the agreement (contract) for conducting testing of reference materials, shall develop, agree with the Applicant, and approve the testing program for the reference materials within the timeframes provided for by the agreement (contract) for conducting testing of reference materials.

The testing program for reference materials shall be developed taking into account the provisions of national standards establishing general requirements for reference materials, their development, testing and application (if national standards exist).

The testing program for reference materials must include:

• content, scope, conditions for conducting testing of reference materials, the quantity (specimens) of reference materials submitted for testing, algorithms for processing the results obtained during testing of reference materials;
• requirements for the procedure for sampling and the quantity of substance (material) of the reference material required for testing;
• methodology for preparing samples of the substance (material) of the reference material for performing measurements;
• methodologies for determining the metrological and technical characteristics of the reference material, including the certified values of the reference material, characteristics of homogeneity, characteristics of stability, accuracy indicators of the reference material;
• methodology for verifying the traceability of the metrological characteristics of the reference material;
• list of competent laboratories of legal entities participating in the interlaboratory experiment (if it is necessary to conduct an interlaboratory experiment during testing);
• analysis of the scientific and technical report on the development of the reference material (if available);
• determination of the metrological and technical characteristics of the reference material, expressed in units of quantities permitted for use in the Russian Federation in accordance with Resolution of the Government of the Russian Federation No. 879 of October 31, 2009 "On Approval of the Regulation on Units of Quantities Permitted for Use in the Russian Federation" (Collected Legislation of the Russian Federation, 2009, No. 45, Art. 5352; 2015, No. 34, Art. 4905);
• use during testing of primary reference measurement procedures (methods), reference measurement procedures (methods), certified measurement procedures (methods); reference standards of units of quantities that meet the requirements of the Regulation on Reference Standards of Units of Quantities Used in the Sphere of State Regulation of Ensuring the Uniformity of Measurements, approved by Resolution of the Government of the Russian Federation No. 734 of September 23, 2010 "On Reference Standards of Units of Quantities Used in the Sphere of State Regulation of Ensuring the Uniformity of Measurements" (Collected Legislation of the Russian Federation, 2010, No. 40, Art. 5066; 2019, No. 43, Art. 6110) (hereinafter - the Regulation on Reference Standards), reference materials of approved type, measuring instruments of approved type that have passed verification.

The testing program for reference materials shall be drawn up on paper or in the form of an electronic document.

The testing program for reference materials on paper shall be drawn up in the number of copies provided for by the agreement (contract) for conducting testing of reference materials, each copy of which shall be agreed with the Applicant and approved by the Tester. The agreement and approval of the testing program for reference materials shall be confirmed by the signatures of the heads or persons authorized by them of the Applicant and the Tester, respectively. The signature of the relevant head or person authorized by them shall be certified by the seal of the organization (if available).

The testing program for reference materials in the form of an electronic document shall be signed with strengthened qualified electronic signatures in accordance with Federal Law No. 63-FZ of April 6, 2011 "On Electronic Signatures" (Collected Legislation of the Russian Federation, 2011, No. 15, Art. 2036; 2016, No. 26, Art. 3889) (hereinafter - strengthened qualified electronic signature) of the heads or persons authorized by them of the Applicant and the Tester.

11. The Applicant, after the approval of the testing program, shall, within the timeframes determined by the agreement (contract) for conducting testing of reference materials, submit to the Tester the quantity (specimens) of reference materials established by the testing program and the scientific and technical report on the development of the reference material (in the event of the development of a scientific and technical report). Reference materials shall be submitted in packaging containing a textual description of the reference material, printed in the form of a stencil and affixed to each unit of packaging of the reference material, containing the name of the producer of the reference material, the name of the reference material, the batch number and date of issue, the shelf life of the reference material, and a photograph of the reference material.
12. The Tester shall conduct testing of reference materials in accordance with the testing program within the timeframes provided for by the agreement (contract) for conducting testing of reference materials. The results of the work provided for by the testing program for reference materials shall be documented in testing protocols.
13. The Tester, based on the results of testing of reference materials, within the timeframes established by the agreement (contract) for conducting testing of reference materials, shall:

• develop a draft description of the type of reference materials;
• prepare a testing report for the reference materials;
• organize an assessment of the testing results in a state scientific metrological institute (by field of activity).

14. The testing report for reference materials shall indicate:

a) the title of the testing report for reference materials, stating the full name and designation of the type of reference material submitted by the Applicant, and the name of the legal entity - Applicant or the surname, first name and patronymic (if any) of the individual entrepreneur - Applicant;

b) information on the conduct of testing of reference materials (name of the Tester, its unique record number of accreditation in the register of accredited persons assigned in accordance with Part 2 of Article 18 of Federal Law No. 412-FZ (hereinafter - unique record number of accreditation in the register of accredited persons), name and designation of the type of reference materials submitted for testing, name of the manufacturer of the reference material, timeframes for conducting testing of reference materials, basis for conducting testing of reference materials indicating the date and number of the application);

c) information on the specimens of reference materials submitted for testing (for reference materials of serial production - the batch number of the reference material submitted for testing for type approval purposes; for reference materials of single-unit production - the numbers of the specimens);

d) full name and designation of the type of reference material tested, and the name of the program under which the testing was conducted;

e) the results of testing of reference materials obtained (established values of metrological and technical characteristics, fact of development of the draft description of the type of reference material);

f) date of signing of the testing report for reference materials.

15. The testing report for reference materials shall be drawn up on paper or in the form of an electronic document. The testing report for reference materials on paper shall be drawn up in the number of copies provided for by the agreement (contract) for conducting testing of reference materials, each of which shall be endorsed by the authorized representative of the Applicant and signed by the head or person authorized by them of the Tester who conducted the testing of reference materials, indicating their positions and the interpretation of signatures (surname and initials). The signature of the head or person authorized by them shall be certified by the seal (if available) of the Tester, and the date of signing of the testing report for reference materials shall be indicated below the signature. The testing report for reference materials in the form of an electronic document shall be signed with strengthened qualified electronic signatures of the heads or persons authorized by them of the Tester and the Applicant.
16. The draft description of the type of reference material must contain:

• name and designation of the type of reference material;
• purpose of the reference material (purpose of the reference material indicating the measurement (testing) methods, measuring instruments for the testing and verification of which the use of the reference material is recommended, and the areas of economy and fields of activity where the use of the reference material is planned);
• description of the reference material (form, dimensions, physical state, material of the reference material, packaging, number of reference materials in a set or kit);
• form of release (single-unit or serial production, continuous or periodically recurring batches);
• metrological characteristics (name of metrological characteristics, range of permissible certified values, limits of permissible error values and (or) permissible values of expanded uncertainty of certified values);
• shelf life of the specimen (the shelf life of the reference material specimen and (or) the frequency of determination of its metrological characteristics shall be indicated);
• type approval mark (the place and method of applying the type approval mark to the accompanying documents of the reference material shall be indicated);
• completeness of the reference material (the completeness of the packaging, the number of specimens of the reference material, the type of packaging with the label in which the reference material is supplied to the consumer, the passport of the reference material, as well as the operational documents for the reference material shall be indicated);
• documents establishing the requirements for the reference material (the name and designation of the technical documentation under which the reference material was or will be produced shall be indicated separately: technical specification, technical conditions (if available), testing program for the reference material for type approval purposes, testing program for the reference material of serial production;
• name and designation of documents defining the application of the reference material: measurement (testing) procedures (methods), verification (calibration) procedures for measuring instruments, documents defining the application of the reference material; name and designation of the document by which the state (local) verification scheme is approved (if available);
• frequency of updating of technical documentation for the reference material);
• number of the specimen (batch) and date of release of the reference materials submitted for testing for type approval purposes;
• information on the manufacturer of the reference materials (names of legal entities or the surname, first name and patronymic (if any) of individual entrepreneurs engaged in the release from production of reference materials of this type, the address of the legal entity and the address of the actual place of activity of the legal entity, or the address of registration at the place of stay or place of residence of the individual for individual entrepreneurs, as well as the taxpayer identification number (hereinafter - TIN) - for manufacturers of reference materials on the territory of the Russian Federation);
• information on the Tester (name, location and address of the legal entity, unique record number of accreditation in the register of accredited persons).

The draft description of the type of reference material shall be drawn up on paper or in the form of an electronic document. All pages of the description of the type of reference material must have consecutive numbering indicating on each page the page number and the total number of pages, and space shall be provided for indicating the position of the authorized person of the Federal Agency for Technical Regulation and Metrology signing the description of the type of reference material, for affixing a signature and its interpretation, as well as for affixing a seal and indicating the date of signing.

17. The testing report for reference materials with attachments on paper in the number of copies provided for by the agreement (contract) for conducting testing of reference materials, or in the form of an electronic document, shall be issued (sent) to the Applicant within the timeframes provided for by the agreement (contract) for conducting testing of reference materials. Simultaneously with the testing report for reference materials, the conclusion on the verification of the testing results and the draft description of the type shall be attached.

The conclusion on the verification of the testing results must contain conclusions on the assessment of the testing results (positive or negative). The results of testing of reference materials shall be deemed positive if the metrological and technical characteristics of the reference materials obtained from the testing results correspond to the declared ones, the obtained testing results of the reference materials satisfy the requirements of the testing program, and the testing program, testing report with testing protocols, and draft description of the type of reference materials are drawn up in accordance with the requirements of this Procedure. The results of testing of reference materials shall be deemed negative if the metrological and technical characteristics of the reference materials obtained from the testing results do not correspond to the declared ones, the obtained testing results of the reference materials do not satisfy all the requirements of the testing program, and the testing program, testing report with testing protocols, and draft description of the type of reference materials are not drawn up in accordance with the requirements of this Procedure.

The draft description of the type of reference material shall be issued (sent) to the Applicant on paper in two copies, one of which shall be endorsed on each page by the signatures of the heads or persons authorized by them of the Applicant and the Tester, or in the form of an electronic document signed with strengthened qualified electronic signatures of the heads or persons authorized by them of the Applicant and the Tester.

III. Testing of Measuring Instruments for Type Approval Purposes

18. The Applicant shall send to the Tester an application for conducting testing of measuring instruments on paper or in the form of an electronic document.

In the event that the Tester is determined as a result of a competitive procurement procedure in accordance with Federal Law No. 44-FZ, the submission of the application for conducting testing of measuring instruments to the Tester shall be carried out after the signing of the agreement (contract) for conducting testing of measuring instruments.

19. The application for conducting testing of measuring instruments must contain the following information:

• name, location and address of the legal entity, or the surname, first name and patronymic (if any), address of registration at the place of stay or place of residence of the individual for the individual entrepreneur acting as the Applicant;
• information on the document confirming the authority of the Applicant to submit the application (order of appointment as head, power of attorney);
• information on the manufacturers of measuring instruments (name of the legal entity and (or) surname, first name, patronymic (if any) of the individual entrepreneur, location and address of the legal entity and (or) address of registration at the place of stay or place of residence of the individual for the individual entrepreneur) (for measuring instruments of serial production);
• name and designation of the type of measuring instrument (the designation of the type of measuring instrument must be presented as a single alphanumeric designation for the approved type of measuring instrument);
• information on modifications (versions) of the measuring instrument (if modifications or versions are included in the type of measuring instrument);
• purpose of the measuring instrument;
• scope of application of the measuring instrument;
• nature of production of the measuring instrument (serial or single-unit);
• information on the availability of a software product used to obtain measurement results;
• declared metrological and technical characteristics of the measuring instrument, including accuracy indicators;
• information on the availability (absence) of a document under which verification of the measuring instrument will be carried out;
• information on the documents under which the measuring instrument is manufactured (only for serial production);
• information on the availability (absence) of a factory and (or) serial number provided for by the design of the measuring instruments in accordance with Part 2 of Article 9 of Federal Law No. 102-FZ (shall be indicated upon the entry into force of these requirements);
• information on the availability of protocols of preliminary testing of the measuring instrument;
• information on mandatory metrological and technical requirements for measuring instruments (shall be provided when indicating areas of application related to the sphere of state regulation of ensuring the uniformity of measurements, as well as when such requirements exist in the technical specifications).

If mandatory requirements specified by the Applicant exist, information shall be provided on the availability of documents confirming compliance with the mandatory requirements established for measuring instruments in accordance with Part 6 of Article 1 of Federal Law No. 102-FZ;

• information in accordance with Part 3 of Article 15 of Federal Law No. 102-FZ on notification of the federal executive body exercising federal state metrological supervision, in accordance with the procedure established by Federal Law No. 294-FZ of December 26, 2008 "On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control" (Collected Legislation of the Russian Federation, 2008, No. 52, Art. 6249; 2019, No. 31, Art. 4469), of the commencement of activities for the production of measuring instruments (for measuring instruments of serial production manufactured on the territory of the Russian Federation);
• information on the availability (absence) of a conclusion of the Ministry of Industry and Trade of the Russian Federation confirming the production of industrial products on the territory of the Russian Federation in accordance with Resolution of the Government of the Russian Federation No. 719 of July 17, 2015 "On Confirmation of the Production of Industrial Products on the Territory of the Russian Federation" (Collected Legislation of the Russian Federation, 2015, No. 30, Art. 4597; 2020, No. 8, Art. 1039) (hereinafter - Resolution No. 719) for measuring instruments submitted for testing (for measuring instruments of serial production, at the request of the Applicant).

The application for conducting testing for measuring instruments of serial production must additionally contain information on the factory numbers of the specimens of measuring instruments submitted for testing, and for measuring instruments of single-unit production - information on the factory numbers of the specimens submitted for testing.

20. The Applicant shall submit together with the application for conducting testing of measuring instruments the accompanying documents for the measuring instrument (operational documents of the measuring instrument (operating manual, form, passport), general view photographs of the measuring instruments and (or) advertising brochures).

Accompanying documents for measuring instruments imported into the territory of the Russian Federation must be prepared in Russian.

21. The Tester shall review the application for conducting testing of measuring instruments within 10 working days from the date of its receipt (in the event that the Tester is not determined as a result of a competitive procurement procedure in accordance with Federal Law No. 44-FZ).

For the purpose of conducting testing of measuring instruments, the Tester shall send to the Applicant a draft agreement (contract) for conducting testing of measuring instruments, including verification of the results of testing of measuring instruments.

In the event of the impossibility of conducting testing of measuring instruments due to the absence of legal grounds for performing the work (lack of accreditation) and (or) the technical capability of the Tester (malfunction or scheduled maintenance on the Tester's equipment), non-compliance of the submitted application for conducting testing of measuring instruments with the requirements of Clause 19 of this Procedure (absence of information specified in the application, its incompleteness or inconsistency), or the absence of factory or serial numbers of the measuring instruments, the Tester shall notify the Applicant in writing thereof, stating the reasons for refusal to conduct testing.

22. The Tester, after signing the agreement (contract) for conducting testing of measuring instruments, shall develop, agree with the Applicant, and approve the testing program for the measuring instruments within the timeframes provided for by the agreement (contract) for conducting testing of measuring instruments.

The testing program for measuring instruments shall be developed taking into account the provisions of national standards establishing general requirements for measuring instruments, their development, testing and application (if relevant national standards exist), as well as mandatory metrological and technical requirements for measuring instruments established by the legislation of the Russian Federation on ensuring the uniformity of measurements and the legislation of the Russian Federation on technical regulation (if they exist).

The testing program for measuring instruments must include:

• description of the measuring instrument as an object of testing, including its composition and completeness;
• number of selected and submitted for testing serially manufactured samples of measuring instruments from the legal entity and individual entrepreneur engaged in the release from production of measuring instruments of this type, information about which is specified in the application for conducting testing of measuring instruments;
• content and scope of testing of measuring instruments;
• methods (methodologies) for testing of measuring instruments;
• conditions for conducting testing of measuring instruments;
• algorithms for processing the results obtained during testing of measuring instruments;
• determination of the metrological and technical characteristics of the measuring instrument, including accuracy indicators, expressed in units of quantities permitted for use in the Russian Federation;
• verification of software identification (if software is available);
• development or selection of a verification procedure for measuring instruments (hereinafter - verification procedure) and its testing;
• determination of the verification interval;
• analysis of the design of the tested measuring instrument for the presence of access restrictions to certain parts of the measuring instruments (including software) in order to prevent unauthorized adjustment and interference that could lead to distortion of measurement results, for the presence of factory and (or) serial numbers ensuring identification of each specimen of measuring instruments, for establishing the place, method and format of applying the factory and (or) serial number in order to ensure readability and preservation of the number during operation of the measuring instrument (in accordance with the requirements of Part 2 of Article 9 of Federal Law No. 102-FZ), and for the possibility of applying the type approval mark and verification mark in places accessible for viewing.

If mandatory requirements for measuring instruments provided for in Part 1 of Article 9 of Federal Law No. 102-FZ exist, including requirements for their components, software and operating conditions of measuring instruments, the testing program must provide for verification of the measuring instrument's compliance with these requirements.

The testing program must provide for the use during testing of primary reference measurement procedures (methods), reference measurement procedures (methods), certified measurement procedures (methods), reference standards of units of quantities that meet the requirements of the Regulation on Reference Standards, reference materials of approved type, measuring instruments of approved type that have passed verification. When conducting testing outside the territory of the Russian Federation using reference standards of units of quantities and measuring instruments of the Applicant, traceability of the reference standards of units of quantities and measuring instruments used to the national primary reference standards of units of quantities of foreign states must be ensured, taking into account the requirements of Clause 18 of Article 2 of Federal Law No. 102-FZ.

The testing program for measuring instruments shall be drawn up on paper or in the form of an electronic document. The testing program for measuring instruments on paper shall be drawn up in the number of copies provided for by the agreement (contract) for conducting testing of measuring instruments, agreed with the Applicant and approved by the Tester. The agreement and approval of the testing program for measuring instruments shall be confirmed by the signatures of the heads or persons authorized by them of the Applicant and the Tester, respectively. The signature of the relevant head or person authorized by them shall be certified by the seal (if available) of the organization. The testing program for measuring instruments in the form of an electronic document shall be signed with strengthened qualified electronic signatures of the heads or persons authorized by them of the Applicant and the Tester.

23. The Applicant, after the approval of the testing program, shall submit for testing the samples of measuring instruments provided for by the testing program within the timeframes provided for by the agreement (contract) for conducting testing of measuring instruments.
24. The Tester shall conduct testing of measuring instruments in accordance with the testing program within the timeframes provided for by the agreement (contract) for conducting testing. The results of the work provided for by the testing program shall be documented in protocols.

Testing protocols must contain the testing results, information on the timeframes of testing, on reference standards of units of quantities, measuring instruments, reference materials, testing equipment and auxiliary means used during testing, as well as information on the compliance of the technical means used for testing with the requirements of the testing program, and information on the place and conditions of testing.

Testing protocols containing the results of testing of verification procedures shall be drawn up in accordance with the procedure for establishing, canceling verification procedures and making amendments to them, provided for in Part 7 of Article 12 of Federal Law No. 102-FZ.

Testing of measuring instruments of single-unit production shall be conducted on all submitted samples of measuring instruments.

25. The Tester, based on the results of testing of measuring instruments, within the timeframes established by the agreement (contract) for conducting testing of measuring instruments, shall develop a draft description of the type of measuring instrument, agree on the verification procedure (if the verification procedure was developed specifically for this type of measuring instrument and has been tested with a positive conclusion on the feasibility of the verification procedure and the possibility of its application for verification of the approved type of measuring instrument), prepare a testing report for the measuring instruments, and organize an assessment of the testing results in a state scientific metrological institute (by field of activity).

The draft description of the type of measuring instrument must contain:

• name and designation of the type of measuring instrument;
• purpose of the measuring instrument (contains a description of the measuring instrument of the approved type indicating for which measurements and for measuring which quantities it is intended);
• description of the measuring instrument (describes its design, principle of operation, number of modifications (versions), their designation and design features, including indication of the places and methods of restricting access to adjustment (tuning) points, places, methods and format of applying factory (serial) numbers or alphanumeric designations that uniquely identify each specimen of measuring instruments);
• software (a description of the software is provided, including its identification data, an assessment of its influence on the metrological characteristics of the measuring instruments and the level of software protection against unintentional and intentional changes is indicated - only if software is available);
• metrological and technical characteristics (metrological and technical characteristics are indicated, including accuracy indicators of the measuring instrument);
• type approval mark (the place and method of applying the type approval mark to the measuring instrument and (or) accompanying documents shall be indicated);
• completeness of the measuring instrument (the completeness of the measuring instrument in which the measuring instrument is supplied to the consumer, including operational documents, shall be indicated);
• information on measurement procedures (methods) (the name of the section of the operational document containing the measurement procedure (method), or the name of the measurement procedure (method) shall be indicated);
• regulatory documents establishing requirements for the measuring instrument (the name and designation of the regulatory document on requirements for the measuring instrument; the name and designation of the regulatory document on requirements for testing methods; the name and designation of the regulatory document on the state (local) verification scheme shall be indicated separately);
• information on the manufacturers of measuring instruments (names of legal entities or the surname, first name and patronymic (if any) of individual entrepreneurs, location and address of the legal entity, or address of registration at the place of stay or place of residence of the individual for individual entrepreneurs, TIN - for manufacturers of measuring instruments on the territory of the Russian Federation);
• information on the Tester (name of the legal entity that conducted the testing of the measuring instrument for type approval purposes, location and address of the legal entity, registration number in the register of accredited persons).

The draft description of the type of measuring instrument shall be developed on paper or in the form of an electronic document.

On paper, all pages of the description of the type of measuring instrument must have consecutive numbering indicating on each page the page number and the total number of pages, and space shall be provided for indicating the position of the authorized person of the Federal Agency for Technical Regulation and Metrology signing the description of the type of measuring instrument, for affixing a signature and its interpretation, as well as for affixing a seal and indicating the date of signing.

26. The testing report for measuring instruments shall indicate:

a) the title of the testing report, stating the name and designation of the type of measuring instrument submitted by the Applicant, and the full name of the legal entity or the surname, first name and patronymic (if any) of the individual entrepreneur - Applicant;

b) information on the conduct of testing of measuring instruments (name of the Tester, its unique record number of accreditation in the register of accredited persons, name and designation of the type of measuring instruments submitted for testing, name of the manufacturer or manufacturers of the measuring instruments, timeframes for conducting testing of measuring instruments, basis for conducting testing indicating the date and number of the application, points of the Tester's scope of accreditation in accordance with which the testing was conducted, place of testing of measuring instruments);

c) information on the samples of measuring instruments submitted for testing and the ones presented for testing (name and designation of the type of measuring instruments, factory numbers) and a conclusion on the possibility of their further use (only for measuring instruments of serial production);

d) general information on the results of testing of measuring instruments (name and designation of the type of measuring instruments tested, name of the program under which the testing of measuring instruments was conducted);

e) information on the results of testing of measuring instruments in accordance with the Testing Program, including:

• established values of metrological and technical characteristics confirmed by the testing results;
• results of verification of compliance with mandatory requirements (if they exist in the testing program);
• identification data of the software (if software is available);
• results of the design analysis (presence of design measures ensuring sufficient protection of the measuring instrument from unauthorized adjustment and interference, or the absence of the need for such protection, presence or absence of factory and (or) serial numbers ensuring identification of each specimen of measuring instruments, and indicating the place, method and form of applying the factory and (or) serial number ensuring readability and preservation of the number during operation of the measuring instruments, the possibility or impossibility of applying the type approval mark and verification mark in places accessible for viewing);
• results of testing the verification procedure with their justification (correctness of the choice of measurement methods during verification, feasibility and sufficiency of the procedures provided for by the verification procedure for confirming the compliance of the measuring instrument with metrological requirements, correctness and sufficiency of verification means for assessing the metrological characteristics of the measuring instrument with the required accuracy, ensuring traceability during verification, the possibility or impossibility of conducting verification of individual measuring channels (for measuring instruments with multiple measuring channels) and (or) individual autonomous blocks from the composition of the measuring instrument (for measuring instruments with multiple individual autonomous blocks), for a smaller number of measured quantities (for measuring instruments intended for measuring multiple quantities) or on a smaller number of measurement subranges (for measuring instruments with multiple measurement subranges), and the presence of corresponding instructions on conducting verification in a shortened scope in the document on the verification procedure (if such verification is possible);
• recommended verification interval with its justification;
• fact of development of the draft description of the type of measuring instrument;

f) information on the results of verification of mandatory metrological and technical requirements for measuring instruments (if they exist in the testing program);

g) date of signing of the testing report for measuring instruments.

27. The testing report for measuring instruments shall be drawn up on paper or in the form of an electronic document. The testing report for measuring instruments on paper shall be drawn up in three copies, each of which shall be endorsed by the authorized representative of the Applicant and signed by the head or person authorized by them of the Tester who conducted the testing of measuring instruments, indicating their positions and the interpretation of signatures (surname and initials). The signature of the head or person authorized by them shall be certified by the seal (if available) of the Tester, and the date of signing of the testing report for measuring instruments shall be indicated below the signature. The testing report for measuring instruments in the form of an electronic document shall be signed with strengthened qualified electronic signatures of the heads or persons authorized by them of the Tester and the Applicant.
28. The testing report for measuring instruments with attachments on paper in two copies or in the form of an electronic document shall be issued (sent) to the Applicant within the timeframes provided for by the agreement (contract) for conducting testing of measuring instruments. The testing protocols shall be attached to the testing report.

Together with the testing report for measuring instruments, the draft description of the type of measuring instruments, the verification procedure, and the conclusion on the verification of the testing results shall be issued.

The draft description of the type of measuring instruments shall be issued drawn up on paper in two copies, one of which shall be endorsed on each page by the signatures of the heads or persons authorized by them of the Applicant and the Tester, or in the form of an electronic document signed with strengthened qualified electronic signatures of the heads or persons authorized by them of the Applicant and the Tester.

The conclusion on the verification of the testing results must contain conclusions on the assessment of the testing results (positive or negative).

The results of testing of measuring instruments shall be deemed positive if:

• the metrological and technical characteristics of the measuring instruments obtained from the testing results correspond to the declared ones;
• the obtained testing results of the measuring instruments satisfy the requirements of the testing program;
• the testing program, testing report with testing protocols, and draft description of the type of measuring instruments are drawn up in accordance with the requirements of this Procedure.

The results of testing of measuring instruments shall be deemed negative if:

• the metrological and technical characteristics of the measuring instruments obtained from the testing results do not correspond to the declared ones;
• the obtained testing results of the measuring instruments do not satisfy the requirements of the testing program;
• the testing program, testing report with testing protocols, and draft description of the type of measuring instruments are not drawn up in accordance with the requirements of this Procedure.

The verification procedure must comply with the requirements for verification procedures provided for in Part 7 of Article 12 of Federal Law No. 102-FZ.

IV. Making Amendments to the Information on Approved Types of Reference Materials or Measuring Instruments

29. When making design changes that affect the metrological characteristics of the reference material or measuring instrument, or changes to the verification interval, to the information on approved types of reference materials or on approved types of measuring instruments placed in the Federal Information Fund for Ensuring the Uniformity of Measurements, testing of reference materials or measuring instruments shall be conducted.
30. When making design changes that do not affect the metrological characteristics of the reference material or measuring instrument to the information on approved types of reference materials or on approved types of measuring instruments placed in the Federal Information Fund for Ensuring the Uniformity of Measurements, testing shall not be conducted; instead, an analysis of the changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and an assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument shall be carried out.
31. The conduct of testing of reference materials or measuring instruments when making changes to the information on approved types of reference materials or on approved types of measuring instruments that affect the metrological characteristics of the reference material or measuring instrument or are related to changes in the verification interval, and the conduct of analysis of changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument, shall be carried out on the basis of an application.

An application for making amendments to the information on approved types of reference materials or on approved types of measuring instruments shall be submitted by:

• the right holder of the approved type of reference materials or the right holder of the approved type of measuring instruments determined in accordance with the procedure for approval of the type of reference materials or type of measuring instruments and making amendments to the information thereon, approved by this Order (hereinafter - the right holder of the approved type);
• the producer of reference materials or the manufacturer of measuring instruments (for reference materials and measuring instruments of serial production whose type was approved before the entry into force of this Order);
• the legal entity or individual entrepreneur engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of reference materials or measuring instruments of this type (for reference materials and measuring instruments of single-unit production whose type was approved before the entry into force of this Order);
• authorized representatives.

32. The right holder of the approved type, or the producer of reference materials, or the manufacturer of measuring instruments (for reference materials and measuring instruments of serial production whose type was approved before the entry into force of this Procedure), or the legal entity or individual entrepreneur engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of reference materials or measuring instruments of this type (for reference materials and measuring instruments of single-unit production whose type was approved before the entry into force of this Procedure), or a person authorized by them, shall send to the Tester an application in free form for conducting testing of reference materials or measuring instruments in respect of the changes being made, or for analysis of changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument, attaching a list and description of the changes being made to the information on the approved type of reference materials or type of measuring instruments.
33. The conduct of testing of reference materials or measuring instruments and their documentation when making amendments to the information on approved types of reference materials or on approved types of measuring instruments shall be carried out in accordance with Clauses 9-16 (for reference materials) and in accordance with Clauses 20-27 (for measuring instruments) of this Procedure in respect of the changes being made.
34. Work on conducting analysis of changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument shall be performed within the framework of concluded agreements (contracts) for the review of documents on making amendments to the approved type of reference materials or type of measuring instruments.

The Tester shall conduct an analysis of the changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and an assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument within the timeframes provided for by the agreement (contract) for the review of documents on making amendments to the approved type of reference materials or measuring instruments.

35. Based on the results of the analysis of changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument, the Tester shall prepare:

• a conclusion based on the results of the review of the design, technological and (or) technical documentation of the reference material or measuring instrument, confirming or not confirming that the changes being made do not affect the metrological characteristics of the reference material or measuring instrument (hereinafter - the conclusion);
• a draft description of the type of reference material or measuring instrument with the changes being made, drawn up in accordance with the requirements of Clauses 16 or 24 of this Procedure (in the event of confirmation that the changes being made do not affect the metrological characteristics of the reference material or measuring instrument).

36. The conclusion must contain:

• information on the documentation submitted for review, indicating the name and designation of the documents;
• information on the changes made to the said documents;
• justifications confirming or not confirming that the changes made do not affect the metrological characteristics of the reference material or measuring instrument, including accuracy indicators, and do not require additional testing;
• information on the changes being made to the draft description of the type of reference material or measuring instrument.

The conclusion shall be drawn up by the Tester who conducted the analysis of changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and the assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument, on paper and signed by the head or person authorized by them of the Tester, or in the form of an electronic document signed with a strengthened qualified electronic signature of the head or person authorized by them of the Tester.

The conclusion shall be issued to the right holder of the approved type, or the producer of reference materials, or the manufacturer of measuring instruments who submitted the application for conducting analysis of changes made to the design, technological and (or) technical documentation of the reference material or measuring instrument and assessment of the impact of the changes made on the metrological characteristics of the reference material or measuring instrument, within the timeframes provided for by the agreement (contract) for the review of documents on making amendments to the approved type of reference materials or type of measuring instruments.

37. When making changes to the information on the verification procedure:

• proposals on the need to make changes to the verification procedure shall be reviewed;
• analysis of the verification procedure and its testing shall be conducted;
• an assessment shall be made of the feasibility of the verification procedure and the possibility of its application for verification of measuring instruments of the approved type in accordance with Clauses 38 and 39 of this Procedure.

38. The right holder of the approved type, or the producer of reference materials, or the manufacturer of measuring instruments (for reference materials and measuring instruments of serial production whose type was approved before the entry into force of this Order), or the legal entity or individual entrepreneur engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of reference materials or measuring instruments of this type (for reference materials and measuring instruments of single-unit production whose type was approved before the entry into force of this Order), or a person authorized by them, shall send to the Tester an application in free form for conducting testing of the verification procedure with changes, or a verification procedure proposed to replace the verification procedure established upon type approval, or in addition to it (hereinafter - the new verification procedure), and for assessment of the feasibility of the verification procedure and the possibility of its application, attaching a draft of the new verification procedure.

Work on testing the new verification procedure and assessment of the feasibility of the new verification procedure and the possibility of its application shall be performed within the framework of concluded agreements (contracts) for testing of the verification procedure, assessment of its feasibility and possibility of application.

The Tester shall conduct testing of the new verification procedure, assessment of its feasibility and possibility of application within the timeframes provided for by the agreement (contract) for testing of the verification procedure, assessment of its feasibility and possibility of application.

Based on the results of testing of the new verification procedure, assessment of its feasibility and possibility of application, the Tester shall:

• prepare a conclusion on the need to make changes to the approved verification procedure with a testing protocol based on the results of testing of the verification procedure in accordance with the procedure for establishing, canceling verification procedures and making amendments to them, provided for in Part 7 of Article 12 of Federal Law No. 102-FZ;
• agree on the new verification procedure (if the verification procedure was developed specifically for this type of measuring instrument and has been tested with a positive conclusion on the feasibility of the verification procedure and the possibility of its application for verification of measuring instruments of the approved type).

39. The conclusion on the need to make changes to the approved verification procedure must contain:

• information on the new verification procedure submitted for testing, indicating its name and designation;
• analysis of proposals for making changes to the approved verification procedure (information on the changes made to the verification procedure);
• conclusion based on the results of testing of the new verification procedure with conclusions on its feasibility and possibility of application;
• justifications for the expediency of establishing the new verification procedure, confirming or not confirming the need to make changes to the approved verification procedure or the need to apply the new verification procedure.

The conclusion shall be drawn up by the Tester who conducted the analysis of changes to the approved verification procedure, on paper and signed by the head or person authorized by them of the Tester, or in the form of an electronic document signed with a strengthened qualified electronic signature of the head or person authorized by them of the Tester.

The conclusion shall be issued to the right holder of the approved type, or the producer of reference materials, or the manufacturer of measuring instruments who submitted the application for conducting testing of the new verification procedure within the timeframes provided for by the agreement (contract) for testing of the verification procedure, assessment of its feasibility and possibility of application.

40. When making changes to the information on the validity period of the approved type of reference materials or type of measuring instruments, a review shall be conducted of the design, technological and (or) technical documentation of the reference material or measuring instrument for compliance of the information on the approved type of reference materials or approved type of measuring instruments with the design, technological and (or) technical documentation of the reference material or measuring instrument and for the absence of changes made thereto.
41. The right holder of the approved type, or the producer of reference materials, or the manufacturer of measuring instruments (for reference materials and measuring instruments of serial production whose type was approved before the entry into force of this Procedure), or a person authorized by them, shall send to the Tester an application in free form for review of the design, technological and (or) technical documentation of the reference material or measuring instrument for compliance of the information on the approved type of reference materials or approved type of measuring instruments with the design, technological and (or) technical documentation of the reference material or measuring instrument and for the absence of changes made thereto. The application shall contain information on the absence or presence of design changes affecting or not affecting the metrological characteristics of the reference material or measuring instrument, on violations identified by federal state metrological supervision bodies or on their absence, on the presence or absence of consumer complaints about the quality of the reference material or measuring instrument during the last period of validity of the approved type of reference materials or type of measuring instruments.

The review of the design, technological and (or) technical documentation of the reference material or measuring instrument by the Tester shall be performed within the framework of a concluded agreement (contract) for the review of documents on making amendments to the approved type of reference materials or measuring instruments.

42. The Tester shall review the design, technological and (or) technical documentation of the reference material or measuring instrument within the timeframes provided for by the agreement (contract) for the review of documents on making amendments to the approved type of reference materials or measuring instruments.

Based on the results of the review, a conclusion based on the results of the review of the design, technological and (or) technical documentation of the reference material or measuring instrument shall be drawn up, which must contain:

• the results of the review of the documentation, the information contained in the application, and the information on the approved type of reference materials or type of measuring instruments contained in the Federal Information Fund for Ensuring the Uniformity of Measurements;
• conclusions based on the results of the review, confirming or not confirming that no changes have been made to the design, technological and (or) technical documentation of the reference material or measuring instrument and that the information on the approved type of reference material or measuring instrument contained in the Federal Information Fund for Ensuring the Uniformity of Measurements corresponds to the design, technological and (or) technical documentation of the reference material or measuring instrument.

The conclusion shall be drawn up by the Tester who conducted the review of the design, technological and (or) technical documentation of the reference material or measuring instrument, on paper and signed by the head or person authorized by them of the Tester, or in the form of an electronic document signed with a strengthened qualified electronic signature of the head or person authorized by them of the Tester.

The conclusion shall be issued to the right holder of the approved type, or the producer of reference materials, or the manufacturer of measuring instruments, or a person authorized by them, who submitted the application for review of the design, technological and (or) technical documentation of the reference material or measuring instrument for compliance of the information on the approved type of reference materials or approved type of measuring instruments with the design, technological and (or) technical documentation of the reference material or measuring instrument and for the absence of changes made thereto, within the timeframes provided for by the agreement (contract) for the review of documents on making amendments to the approved type of reference materials or measuring instruments.

Appendix No. 2
to the Order of the Ministry of Industry and Trade of Russia
No. 2905 of August 28, 2020

PROCEDURE FOR APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS, AND FOR MAKING AMENDMENTS TO THE INFORMATION THEREON

(as amended by Order of the Ministry of Industry and Trade of the Russian Federation No. 3388 of August 12, 2022)

1. This Procedure establishes the procedures for approval of the type of reference materials or type of measuring instruments, as well as for making amendments to the information on approved types of reference materials or types of measuring instruments.
2. The type of reference materials or type of measuring instruments used in the sphere of state regulation of ensuring the uniformity of measurements, in accordance with Part 2 of Article 12 of Federal Law No. 102-FZ of June 26, 2008 "On Ensuring the Uniformity of Measurements" (Collected Legislation of the Russian Federation, 2008, No. 26, Art. 3021; 2019, No. 52, Art. 7814) (hereinafter - Federal Law No. 102-FZ), shall be approved by a decision of the Federal Agency for Technical Regulation and Metrology.

Approval of the type of measuring instruments used in the field of defense and state security shall be carried out taking into account the specific features provided for in Clause 9 of the Regulation on the Specific Features of Ensuring the Uniformity of Measurements in the Implementation of Activities in the Field of Defense and Security of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 780 of October 2, 2009.

Approval of the type of reference materials and type of measuring instruments not intended for use in the sphere of state regulation of ensuring the uniformity of measurements shall be carried out in accordance with Part 8 of Article 12 of Federal Law No. 102-FZ on a voluntary basis.

3. The decision on approval of the type of reference materials or type of measuring instruments shall be adopted on the basis of positive results of testing of reference materials or measuring instruments for type approval purposes (hereinafter - testing of reference materials or measuring instruments).

The said decision shall be the basis for entering information on the approval of the type of reference material or type of measuring instrument into the Federal Information Fund for Ensuring the Uniformity of Measurements.

4. For the purpose of considering the issue of approval of the type of reference material or type of measuring instrument, legal entities and individual entrepreneurs who, depending on the nature of production of reference materials or measuring instruments, carry out development, release from production, import into the territory of the Russian Federation, sale and use on the territory of the Russian Federation of reference materials or measuring instruments (hereinafter - Applicants), as well as persons authorized by them (hereinafter - authorized representative of the Applicant), shall submit to the Federal Agency for Technical Regulation and Metrology an application for approval of the type of reference material or type of measuring instrument. The application for approval of the type of reference material or type of measuring instrument shall be submitted on paper or in electronic form using the federal state information system "Unified Portal of State and Municipal Services (Functions)," provided for by Federal Law No. 210-FZ of July 27, 2010 "On the Organization of the Provision of State and Municipal Services" (Collected Legislation of the Russian Federation, 2010, No. 31, Art. 4179; 2020, No. 31, Art. 5027) (hereinafter - the Unified Portal).

Applicants for approval of the type of reference material or type of measuring instrument of serial production may be legal entities and individual entrepreneurs engaged in the release from production of reference materials or measuring instruments (hereinafter - manufacturers of measuring instruments, producers of reference materials).

Applicants for approval of the type of reference material or type of measuring instrument of single-unit production may be legal entities and individual entrepreneurs engaged in the development, import into the territory of the Russian Federation, sale and use on the territory of the Russian Federation of reference materials or measuring instruments.

5. The application for approval of the type of reference material must contain:

• a request to consider the issue of approval of the type of reference material, indicating its name and designation;
• information on the producers of reference materials (name of the legal entity and (or) surname, first name, patronymic (if any) of the individual entrepreneur, location and address of the legal entity and (or) address of registration at the place of stay or place of residence of the individual for the individual entrepreneur) (for reference materials of serial production);
• information on the right holders of the approved type of reference materials (name of the legal entity or surname, first name, patronymic (if any) of the individual entrepreneur, location and address of the legal entity or address of registration at the place of stay or place of residence of the individual for the individual entrepreneur).

The right holders of the approved type of reference materials shall be indicated as legal entities or individual entrepreneurs engaged in the release from production of reference materials of this type (for reference materials of serial production), legal entities or individual entrepreneurs engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of reference materials of this type (for reference materials of single-unit production), who, after approval of the type of reference materials, shall have the right to make amendments to the information on the approved type of reference materials and shall be the holders in accordance with GOST 2.501-2013 "Unified System of Design Documentation (ESKD). Rules for Accounting and Storage" <1> (hereinafter - GOST 2.501-2013) of the original documents under which the production of reference materials is carried out or was carried out (hereinafter - right holders of the approved type of reference materials).

<1> Order of the Federal Agency for Technical Regulation and Metrology No. 1628-st of November 22, 2013, M.: Standartinform, 2014.

The following shall be attached to the application for approval of the type of reference material:

• technical specification (technical conditions for the development of the reference material), in the form of a copy certified by the head (person authorized by them) of the legal entity or by the individual entrepreneur (person authorized by them) who are the holders in accordance with GOST 2.501-2013 (hereinafter - the holder) of the originals of these documents, or in the form of an electronic document signed with a strengthened qualified electronic signature of the holder of these documents;
• testing program for the reference material for type approval purposes;
• scientific and technical report of the producer of reference materials on the development of the reference material, containing a description and selection of the material of the reference material corresponding to its purpose, justification for the selection of metrological and technical characteristics, shelf life of the reference material, description of conditions of use, storage, transportation (if there are special transportation conditions);
• testing report for the reference material with testing protocols;
• conclusion on the verification of the testing results of the reference material of the state scientific metrological institute (by field of activity) in accordance with Clause 6 of Appendix 2 to the methodology for determining the amount of the fee for providing services for testing reference materials or measuring instruments for type approval purposes in the field of ensuring the uniformity of measurements, approved by Order of the Ministry of Industry and Trade of the Russian Federation No. 4189 of November 11, 2019 (registered with the Ministry of Justice of the Russian Federation on February 14, 2020, Registration No. 57505);
• draft description of the type of reference material on paper in two copies or in the form of an electronic document, issued based on the results of testing of the reference material for type approval purposes;
• copy of the passport of the reference material;
• accompanying documents for the reference materials (passport of the reference material or certificate of the reference material - for reference materials imported into the territory of the Russian Federation), drawn up in Russian;
• copy of the label of the reference material;
• copy of the application for conducting testing;
• document confirming the authority of the legal entity or individual entrepreneur to represent the Applicant (only when the application is submitted by an authorized representative of the Applicant, only for reference materials of serial production).

In the event of submitting the application for approval of the type of reference material in electronic form using the Unified Portal, electronic copies of the documents specified in this clause shall be attached to the completed electronic form of the application for approval of the type of reference material on the Unified Portal, and a file with the draft description of the type of reference material in text format shall additionally be attached.

6. The application for approval of the type of measuring instruments must contain:

• a request to consider the issue of approval of the type of measuring instrument, indicating its name and designation (the designation of the type of measuring instrument must contain only one unified alphanumeric designation; the description of the type may indicate several names and designations of modifications and versions of this type of measuring instrument);
• information on the manufacturers of measuring instruments (name of the legal entity and (or) surname, first name, patronymic (if any) of the individual entrepreneur, location and address of the legal entity and (or) address of registration at the place of stay or place of residence of the individual for the individual entrepreneur) (for measuring instruments of serial production);
• information on the right holders of the approved type of measuring instruments (name of the legal entity or surname, first name, patronymic (if any) of the individual entrepreneur, location and address of the legal entity or address of registration at the place of stay or place of residence of the individual for the individual entrepreneur);
• information on the registration of a notification of the commencement of activities for the production of measuring instruments in accordance with Part 3 of Article 15 of Federal Law No. 102-FZ, submitted in accordance with Federal Law No. 294-FZ of December 26, 2008 "On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control" (Collected Legislation of the Russian Federation, 2008, No. 52, Art. 6249; 2018, No. 32, Art. 5116) (hereinafter - Federal Law No. 294-FZ) (only for measuring instruments of serial production manufactured on the territory of the Russian Federation);
• proposals for establishing a verification procedure and a recommended verification interval.

The right holders of the approved type of measuring instruments shall be legal entities or individual entrepreneurs engaged in the release from production of measuring instruments of this type (for measuring instruments of serial production), legal entities or individual entrepreneurs engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of measuring instruments of this type (for measuring instruments of single-unit production) and who are the holders of the originals of the documents under which the manufacture of measuring instruments is or was carried out (hereinafter - right holders of the approved type of measuring instruments).

On a voluntary basis, for the purpose of confirming that measuring instruments of serial production meet the criteria for confirmation of production of industrial products on the territory of the Russian Federation, the application for approval of the type of measuring instruments shall additionally indicate information on the availability of a conclusion on confirmation of production of industrial products on the territory of the Russian Federation, issued by the Ministry of Industry and Trade of the Russian Federation in accordance with Resolution of the Government of the Russian Federation No. 719 of July 17, 2015 "On Confirmation of the Production of Industrial Products on the Territory of the Russian Federation" (Collected Legislation of the Russian Federation, 2015, No. 30, Art. 4597; 2020, No. 8, Art. 1039) (hereinafter - Resolution No. 719).

The following shall be attached to the application for approval of the type of measuring instruments:

• testing report drawn up based on the results of testing of measuring instruments for type approval purposes;
• testing protocols as annexes to the testing report;
• conclusion on the verification of the testing results in accordance with Clause 10 of Appendix 1 to the methodology for determining the amount of the fee for providing services for testing reference materials or measuring instruments for type approval purposes in the field of ensuring the uniformity of measurements, approved by Order of the Ministry of Industry and Trade of the Russian Federation No. 4189 of November 11, 2019 (registered with the Ministry of Justice of the Russian Federation on February 14, 2020, Registration No. 57505);
• draft description of the type on paper in two copies or in the form of an electronic document, issued based on the results of testing of measuring instruments for type approval purposes;
• verification procedure (in the event that the verification procedure was developed specifically for the approved type of measuring instruments);
• testing program for measuring instruments for type approval purposes;
• set of operational documents for the measuring instrument (in Russian, including for measuring instruments imported into the territory of the Russian Federation), drawn up in the form of a copy certified by the head or person authorized by them of the legal entity or by the individual entrepreneur (person authorized by them) who are the holders of the originals of these documents (translations of these documents into Russian for measuring instruments of serial production manufactured outside the Russian Federation), or in the form of an electronic document signed with a strengthened qualified electronic signature of the holder of these documents (translation of these documents into Russian for measuring instruments of serial production manufactured outside the Russian Federation);
• technical conditions or enterprise standard (in Russian, including for measuring instruments imported into the territory of the Russian Federation), drawn up in the form of a copy certified by the head or person authorized by them of the legal entity or by the individual entrepreneur (person authorized by them) who are the holders of these documents (translations of these documents into Russian for measuring instruments of serial production manufactured outside the Russian Federation), or in the form of an electronic document signed with a strengthened qualified electronic signature of the holder of these documents (translations of these documents into Russian for measuring instruments of serial production manufactured outside the Russian Federation) (only for measuring instruments of serial production);
• copy of the application for conducting testing;
• document confirming the authority of the legal entity or individual entrepreneur to represent the Applicant (only when the application is submitted by an authorized representative of the Applicant, only for measuring instruments of serial production).

In the event of submitting the application for approval of the type of measuring instrument in electronic form using the Unified Portal, electronic copies of the documents specified in this clause shall be attached to the completed electronic form of the application for approval of the type of measuring instrument on the Unified Portal, and a file with the draft description of the type of reference material in text format shall additionally be attached.

7. The decision on approval of the type, including the entry of documents and information on the approved type (on amendments made to the information on the approved type) into the Federal Information Fund for Ensuring the Uniformity of Measurements, or on refusal of approval of the type, shall be adopted by the Federal Agency for Technical Regulation and Metrology within a period not exceeding 30 working days from the date of registration of the application for approval of the type of reference materials or type of measuring instruments. (as amended by Order of the Ministry of Industry and Trade of the Russian Federation No. 3388 of August 12, 2022)

The decision on approval of the type shall be adopted in the form of an order on approval of the type of reference materials or type of measuring instruments, subject to positive testing results according to the conclusion on the verification of the testing results and compliance of the documents submitted with the application for approval of the type of reference materials or type of measuring instruments with the requirements of Clauses 5 and 6 of this Procedure. The results of testing of reference materials and measuring instruments shall be deemed positive if the metrological and technical characteristics of the reference materials and measuring instruments obtained from the testing results correspond to the declared ones, the obtained testing results of the reference materials and measuring instruments satisfy the requirements of the testing program, and the testing program, testing report with testing protocols, and draft description of the type of reference materials or type of measuring instruments are drawn up in accordance with the requirements of the procedure for conducting testing of reference materials or measuring instruments for type approval purposes, approved by this Order.

The decision on approval of the type of reference materials or type of measuring instruments of serial production shall apply to reference materials and measuring instruments that correspond to their type description and are manufactured during the period of validity of the approved type (within 5 years from the date of signing of the order on approval of the type of reference materials or type of measuring instruments), manufactured for testing of reference materials or measuring instruments and (or) submitted for such testing, information about which is contained in the materials of testing of reference materials or measuring instruments, as well as manufactured after the approval of the testing report for reference materials or measuring instruments, on the basis of which the decision on approval of the type was adopted, until the date of adoption of such decision (the date of signing of the order is included in the validity period of the approved type), and shall be valid indefinitely.

The decision on approval of the type of reference materials or type of measuring instruments of single-unit production shall apply to the reference materials and measuring instruments directly specified in the order on approval of the type and corresponding to their type description, and shall be valid indefinitely for measuring instruments and for the shelf life of the reference material specimen.

When extending the decision on approval of the type to previously manufactured reference materials or measuring instruments of serial production that are in operation and correspond to the type description, the relevant instructions must be contained in the order on approval of the type of reference materials or type of measuring instruments. The date of manufacture of the reference material or measuring instrument shall be deemed the date indicated by its manufacturer in the operational document of the measuring instrument or in the passport of the reference material, from which the measuring instrument or reference material is recognized as fit for operation (use). Information on specimens of reference materials and measuring instruments manufactured for testing for type approval purposes and (or) submitted for such testing, as well as the date of approval of the testing report on the basis of which the decision on approval of the type was adopted, shall be transferred to the Federal Information Fund for Ensuring the Uniformity of Measurements.

The decision on refusal of approval of the type shall be adopted subject to negative testing results according to the conclusion on the verification of the testing results and (or) non-compliance of the documents submitted with the application for approval of the type of reference materials or type of measuring instruments with the requirements of Clauses 5 and 6 of this Procedure. The results of testing of reference materials and measuring instruments shall be deemed negative if the metrological and technical characteristics of the reference materials and measuring instruments obtained from the testing results do not correspond to the declared ones, the obtained testing results of the reference materials and measuring instruments do not satisfy the requirements of the testing program, and the testing program, testing report with testing protocols, and draft description of the type of reference materials or type of measuring instruments are not drawn up in accordance with the requirements of the procedure for conducting testing of reference materials or measuring instruments for type approval purposes, approved by this Order.

The decision on refusal of approval of the type of reference materials or type of measuring instruments, stating the reasons for refusal, shall be communicated by the Federal Agency for Technical Regulation and Metrology to the applicant by letter or in electronic form using the Unified Portal (depending on and in accordance with the method of submission of the application).

8. The order on approval of the type of reference materials shall indicate information on the approved type of reference materials (name and designation of the type of reference materials, factory numbers for reference materials of single-unit production), information on the manufacturer of the approved type of reference materials, and information on the right holder of the approved type of reference materials.
9. The order on approval of the type of measuring instruments shall indicate information on the approved type of measuring instruments (name and designation of the type of measuring instruments, factory numbers for measuring instruments of single-unit production, identification code of production of measuring instruments, accuracy indicators), information on the manufacturer of the approved type of measuring instruments, information on the right holder of the approved type of measuring instruments, the verification procedure and the verification interval for the measuring instrument.

The identification code of production of measuring instruments shall be denoted by two capital letters: RF - for measuring instruments that meet the criteria for confirmation of production of industrial products on the territory of the Russian Federation in accordance with Resolution No. 719, OS - for other measuring instruments.

10. The order on approval of the type of reference materials or type of measuring instruments shall approve the description of the type of reference material or type of measuring instrument.
11. Amendments to the information on the approved type of reference materials or type of measuring instruments shall be made upon application of the right holders of the approved type of reference materials or right holders of the approved type of measuring instruments, information about whom is contained in the Federal Information Fund for Ensuring the Uniformity of Measurements, or producers of reference materials or manufacturers of measuring instruments (for reference materials and measuring instruments of serial production whose type was approved before the entry into force of this Order), or legal entities or individual entrepreneurs engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of reference materials or measuring instruments of this type (for reference materials and measuring instruments of single-unit production whose type was approved before the entry into force of this Order), or persons authorized by them.
12. For the purpose of considering the issue of making amendments to the information on the approved type of reference materials or type of measuring instruments, the right holders of the approved type of reference materials or type of measuring instruments, or producers of reference materials or manufacturers of measuring instruments (for reference materials and measuring instruments whose type was approved before the entry into force of this Order), shall submit to the Federal Agency for Technical Regulation and Metrology an application for making amendments to the information on the approved type of reference materials or type of measuring instruments (hereinafter - the application for making amendments to the information).

The application for making amendments to the information shall be drawn up depending on the reason for making amendments to the information on the approved type of reference materials or type of measuring instruments (hereinafter - making amendments to the information) and includes:

a) when making amendments to the information in respect of design changes to the reference material or measuring instrument that do not affect its metrological characteristics, the application for making amendments to the information shall indicate the name and designation of the reference material or measuring instrument to whose approved type information the changes are being made, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements, and the reason for making the amendments (making design changes that do not affect the metrological characteristics of the reference material or measuring instrument).

The following shall be attached to the application for making amendments to the information in respect of design changes to the reference material or measuring instrument that do not affect its metrological characteristics:

• conclusion based on the results of the review of the design, technological and (or) technical documentation of the reference material or measuring instrument, drawn up in accordance with the procedure for conducting testing of reference materials or measuring instruments for type approval purposes, approved by this Order (hereinafter - the conclusion), and confirming that the changes being made to the design of the reference material or measuring instrument do not affect the metrological characteristics of the reference material or measuring instrument, including accuracy indicators;
• draft description of the type of reference material or measuring instrument with the changes being made to the information on the design of the reference material or measuring instrument, drawn up in accordance with the procedure for conducting testing of reference materials or measuring instruments for type approval purposes, approved by this Order;
• verification procedure with the changes made (if changes are made to it);
• document confirming the authority of the legal entity or individual entrepreneur to represent the right holder of the type of reference material or type of measuring instrument (when the application for making amendments is submitted by an authorized representative of the Applicant);

b) when making amendments to the information in respect of design changes to the reference material or measuring instrument that affect its metrological characteristics, including accuracy indicators, the application for making amendments to the information shall indicate the name and designation of the reference material or measuring instrument to whose approved type the changes are being made, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements, and the reason for making the amendments (making design changes that affect the metrological characteristics of the reference material or measuring instrument).

The following shall be attached to the application for making amendments to the information in respect of design changes to the reference material or measuring instrument that affect its metrological characteristics:

• testing report for the reference material or measuring instrument for type approval purposes with testing protocols, drawn up based on the results of testing of reference materials or measuring instruments for type approval purposes in respect of the changes being made;
• conclusion on the verification of the testing results of the reference material or measuring instrument;
• draft description of the type of reference material or measuring instrument with the changes being made, drawn up in accordance with the Procedure for Conducting Testing of Reference Materials or Measuring Instruments for Type Approval Purposes, approved by this Order;
• testing program;
• set of operational documents with changes (in Russian, including for measuring instruments imported into the territory of the Russian Federation), technical conditions or enterprise standard with changes (in Russian, only for reference materials or measuring instruments of serial production), drawn up in the form of copies certified by the head or person authorized by them of the legal entity or by the individual entrepreneur (person authorized by them) who are the holders of the originals of these documents;
• document confirming the authority of the legal entity or individual entrepreneur to represent the right holder (right holders) of the approved type of reference material or type of measuring instrument (when the application for making amendments is submitted by an authorized representative of the Applicant);
• verification procedure (only for measuring instruments, if changes are made to it);
• copy of the application for conducting testing indicating the changes being made;

c) when making amendments to the information in respect of the validity period of the approved type of reference materials or type of measuring instruments, the application for making amendments to the information shall indicate:

• name and designation of the type of reference materials or type of measuring instruments whose validity period is being extended, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements;
• reason for making the amendments (extension of the validity period of the approved type of reference materials or type of measuring instruments);
• information on the registration of a notification of the commencement of activities for the production of measuring instruments in accordance with Federal Law No. 294-FZ (only for measuring instruments of serial production manufactured on the territory of the Russian Federation):
• statement on the absence of design changes affecting or not affecting the metrological characteristics of the reference material or measuring instrument;
• statement on the absence of violations identified by federal state metrological supervision bodies;
• statement on the absence of consumer complaints about the quality of the reference material or measuring instrument during the last period of validity of the approved type of reference materials or type of measuring instruments.

On a voluntary basis, for the purpose of confirming that measuring instruments of serial production meet the criteria for confirmation of production of industrial products on the territory of the Russian Federation, the applicant shall additionally indicate in the application for making amendments information on the availability of a conclusion on confirmation of production of industrial products on the territory of the Russian Federation, issued by the Ministry of Industry and Trade of the Russian Federation in accordance with Resolution No. 719.

The following shall be attached to the application for making amendments to the information in respect of the validity period of the approved type of reference materials or type of measuring instruments:

• conclusion based on the results of the review of the design, technological and (or) technical documentation of the reference material or measuring instrument, drawn up in accordance with the procedure for conducting testing of reference materials or measuring instruments for type approval purposes, approved by this Order (hereinafter - the conclusion), and confirming that no changes have been made to the design, technological and (or) technical documentation of the reference material or measuring instrument and that the information on the approved type of reference material or measuring instrument contained in the Federal Information Fund for Ensuring the Uniformity of Measurements corresponds to the design, technological and (or) technical documentation of the reference material or measuring instrument.

The application for making amendments when making changes to the information in respect of the validity period of the approved type of reference materials or type of measuring instruments shall be submitted no later than 30 working days before the expiry of the validity period of the approved type of reference materials or type of measuring instruments.

d) when making amendments to the information in respect of information on producers of reference materials or manufacturers of measuring instruments, in the event of reorganization or renaming (only for serial production), or on right holders of the approved type of reference materials or type of measuring instruments, the application for making amendments to the information shall indicate the name and designation of the reference material or measuring instrument to whose approved type the changes are being made, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements, the reason for making the amendments (making changes to the information on producers of reference materials or manufacturers of measuring instruments, or right holders of the approved type of reference materials or type of measuring instruments), and the new information on producers of reference materials or manufacturers of measuring instruments, or right holders of the approved type of reference materials or type of measuring instruments.

The following shall be attached to the application for making amendments to the information in respect of information on producers of reference materials (manufacturers of measuring instruments), right holders of the approved type of reference materials (measuring instruments):

• draft description of the type with the changes being made to the name of the producer of the reference material or manufacturer of the measuring instrument, or right holder of the approved type of reference materials or type of measuring instruments, drawn up in accordance with the requirements of the procedure for conducting testing of reference materials or measuring instruments for type approval purposes, approved by this Order;
• document confirming the fact of reorganization or renaming (when making changes to the information on the producer of reference materials, manufacturer of measuring instruments, or right holder of the approved type of reference material or type of measuring instrument operating outside the Russian Federation);

e) when making amendments to the information in respect of the verification interval established for the measuring instrument upon type approval, the application for making amendments to the information shall indicate the name and designation of the measuring instrument to whose approved type the changes are being made, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements, and the reason for making the amendments (making changes to the information on the verification interval).

The following shall be attached to the application for making amendments to the information in respect of the verification interval:

• testing program for type approval of measuring instruments in respect of determining the duration of the proposed verification interval;
• testing report for type approval of measuring instruments in respect of determining the duration of the proposed verification interval with testing protocols;
• conclusion on the verification of the testing results;

f) when making amendments to the information in respect of the verification procedure established upon type approval of measuring instruments, the application for making amendments to the information shall indicate the name and designation of the measuring instrument to whose approved type the changes are being made, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements, and the reason for making the amendments (making changes to the information on the verification procedure).

The following shall be attached to the application for making amendments to the information in respect of the verification procedure:

• conclusion on the need to make changes to the verification procedure in accordance with the procedure for establishing, canceling verification procedures and making amendments to them, provided for in Part 7 of Article 12 of Federal Law No. 102-FZ, with justification of the expediency of making changes to the approved verification procedure and the results of its testing;
• verification procedure with changes;

g) when making amendments to the information in respect of the identification code of production of measuring instruments (for measuring instruments of serial production), the application for making amendments to the information shall indicate the name and designation of the measuring instrument to whose approved type the changes are being made, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements, the reason for making the amendments (making changes to the information on the identification code of production of measuring instruments), and information on whether the Applicant has a conclusion on confirmation of production of industrial products on the territory of the Russian Federation, issued by the Ministry of Industry and Trade of the Russian Federation in accordance with Resolution No. 719.

h) when making amendments to the information in respect of the place of activity of the producer of reference materials (for reference materials of serial production) or manufacturer of measuring instruments (for measuring instruments of serial production), the application for making amendments to the information shall indicate the name and designation of the reference material or measuring instrument to whose approved type the changes are being made, its registration number in the Federal Information Fund for Ensuring the Uniformity of Measurements, the reason for making the amendments (making changes to the information on the place of activity), and shall also include a statement on the preservation of the quality of reference materials or measuring instruments released from production at the new place of activity.

13. The decision on making amendments to the information on the approved type of reference materials or measuring instruments shall be adopted by the Federal Agency for Technical Regulation and Metrology in the form of an order. The decision on making amendments to the information on the approved type of reference materials or measuring instruments when making changes to the information on the validity period of the approved type of reference materials or type of measuring instruments shall be adopted with an extension of the validity period for the subsequent 5 years from the date of expiry of the validity period of the approved type of reference materials or measuring instruments.
14. The decision on approval of the type (on making amendments to the information on the approved type) of reference materials or type of measuring instruments shall be placed on the official website of the Federal Agency for Technical Regulation and Metrology within a period not exceeding 5 working days from the date of signing of the order.
15. First paragraph. - No longer in force. (as amended by Order of the Ministry of Industry and Trade of the Russian Federation No. 3388 of August 12, 2022)

Documents and information on the approved type of measuring instruments used in the field of defense and state security (on amendments made to the information on the approved type) shall be sent by the Federal Agency for Technical Regulation and Metrology within a period not exceeding 5 working days from the date of signing of the order, in accordance with the Specific Features of the Organization and Maintenance of Sections of the Federal Information Fund for Ensuring the Uniformity of Measurements in the Field of Defense and State Security, approved by Order of the Ministry of Industry and Trade of the Russian Federation No. 958 of March 30, 2016 (registered with the Ministry of Justice of the Russian Federation on December 5, 2016, Registration No. 44563), for entering information into the sections of the Federal Information Fund for Ensuring the Uniformity of Measurements in the field of defense and state security.

Appendix No. 3
to the Order of the Ministry of Industry and Trade of Russia
No. 2905 of August 28, 2020

PROCEDURE FOR ISSUING CERTIFICATES OF APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS

(as amended by Order of the Ministry of Industry and Trade of the Russian Federation No. 3388 of August 12, 2022)

1. This Procedure establishes the rules for drawing up and issuing certificates of approval of the type of reference materials or type of measuring instruments.
2. The issuance of certificates of approval of the type of reference materials or type of measuring instruments (hereinafter - the certificate) shall be carried out by the Federal Agency for Technical Regulation and Metrology on the basis of applications from:

• right holders of the approved type of reference materials or approved type of measuring instruments, information about whom is contained in the Federal Information Fund for Ensuring the Uniformity of Measurements;
• or legal entities or individual entrepreneurs engaged in the release from production of reference materials or measuring instruments of this type (for reference materials and measuring instruments of serial production whose type was approved before the entry into force of this Procedure);
• or legal entities or individual entrepreneurs engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of reference materials or measuring instruments of this type (for reference materials and measuring instruments of single-unit production whose type was approved before the entry into force of this Procedure);
• or persons authorized by them (hereinafter - the representative of the right holder).

The application for issuance of a certificate shall be submitted on paper or in electronic form, including through the use of the federal state information system "Unified Portal of State and Municipal Services (Functions)," provided for by Federal Law No. 210-FZ of July 27, 2010 "On the Organization of the Provision of State and Municipal Services" (Collected Legislation of the Russian Federation, 2010, No. 31, Art. 4179; 2019, No. 52, Art. 7790).

3. The certificate shall be drawn up in a single copy separately for each type of reference material or type of measuring instrument, taking into account the nature of their production (serial or single-unit), in accordance with the forms approved by this Order.

The certificate shall be drawn up provided that information on the approved type of reference material or type of measuring instrument is available in the Federal Information Fund for Ensuring the Uniformity of Measurements.

In the certificate of approval of the type of reference materials, the validity period of the approved type of reference materials shall be indicated as 5 years for reference materials of serial production, and according to the shelf life of the reference material specimen for reference materials of single-unit production.

In the certificate of approval of the type of measuring instruments, the validity period of the approved type of measuring instruments shall be indicated as 5 years for measuring instruments of serial production; for measuring instruments of single-unit production, the validity period shall not be indicated.

The identification code of production of measuring instruments indicated in the certificate of approval of the type of measuring instruments shall be denoted by two capital letters: RF - for measuring instruments that meet the criteria for confirmation of production of industrial products on the territory of the Russian Federation in accordance with Resolution of the Government of the Russian Federation No. 719 of July 17, 2015 "On Confirmation of the Production of Industrial Products on the Territory of the Russian Federation" (Collected Legislation of the Russian Federation, 2015, No. 30, Art. 4597; 2020, No. 8, Art. 1039), OS - for other measuring instruments.

The certificate number shall be the registration number of the approved type of reference materials or type of measuring instruments, assigned in accordance with the procedure for the creation and maintenance of the Federal Information Fund for Ensuring the Uniformity of Measurements, the transfer of information to it and the amendment of such information, and the provision of documents and information contained therein, provided for in Part 7 of Article 12 of Federal Law No. 102-FZ of June 26, 2008 "On Ensuring the Uniformity of Measurements" (Collected Legislation of the Russian Federation, 2008, No. 26, Art. 3021; 2019, No. 52, Art. 7814) (hereinafter - Federal Law No. 102-FZ).

4. When an application for issuance of a certificate of approval of the type of reference materials or type of measuring instruments is submitted, the drawing up, signing and issuance (sending) of the certificate to the legal entity or individual entrepreneur who submitted the application for issuance of the certificate shall be carried out within a period not exceeding five working days from the date of registration of the application for issuance of the certificate with Rosstandart. (as amended by Order of the Ministry of Industry and Trade of the Russian Federation No. 3388 of August 12, 2022)

A description of the type of reference materials or type of measuring instruments shall be attached to the certificate. (as amended by Order of the Ministry of Industry and Trade of the Russian Federation No. 3388 of August 12, 2022)

5. The certificate shall not be drawn up and its issuance by the Federal Agency for Technical Regulation and Metrology shall not be carried out if:

• there is no information on the approved type of reference material or type of measuring instrument specified in the application in the Federal Information Fund for Ensuring the Uniformity of Measurements;
• the application is submitted by a legal entity or individual entrepreneur who is not the right holder of the approved type of reference material or type of measuring instrument, or is not the legal entity or individual entrepreneur engaged in the release from production of reference materials or measuring instruments of this type (for reference materials and measuring instruments of serial production whose type was approved before the entry into force of this Order), or is not the legal entity or individual entrepreneur engaged in the development, import into the territory of the Russian Federation, sale on the territory of the Russian Federation, or use of reference materials or measuring instruments of this type (for reference materials and measuring instruments of single-unit production whose type was approved before the entry into force of this Order), or is not the representative of the right holder.

6. In the event of refusal to issue the certificate, the Federal Agency for Technical Regulation and Metrology shall, within a period not exceeding ten working days from the date of registration of the application, send to the legal entity or individual entrepreneur who submitted the application for issuance of the certificate a notification of refusal to issue the certificate, stating the reasons for refusal.

Appendix No. 4
to the Order of the Ministry of Industry and Trade of Russia
No. 2905 of August 28, 2020

FORMS OF CERTIFICATES OF APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS

I. Form of Certificate of Approval of the Type of Reference Materials

FEDERAL AGENCY FOR TECHNICAL REGULATION AND METROLOGY

CERTIFICATE
of Approval of the Type of Reference Materials

Validity period of type approval until _____________________

 

 

The type of reference material was approved by order of the Federal Agency for Technical Regulation and Metrology dated _________ No. ________.

 

 

II. Form of Certificate of Approval of the Type of Measuring Instruments

FEDERAL AGENCY FOR TECHNICAL REGULATION AND METROLOGY

CERTIFICATE
of Approval of the Type of Measuring Instruments

 

 

Validity period of type approval until_____________________

 

The type of measuring instrument was approved by order of the Federal Agency for Technical Regulation and Metrology dated _________ No. ________.

 

Appendix No. 5
to the Order of the Ministry of Industry and Trade of Russia
No. 2905 of August 28, 2020

REQUIREMENTS FOR MARKS OF APPROVAL OF THE TYPE OF REFERENCE MATERIALS OR TYPE OF MEASURING INSTRUMENTS AND THE PROCEDURE FOR THEIR APPLICATION

1. The mark of approval of the type of reference materials or type of measuring instruments (hereinafter - the type approval mark) shall be used in the sphere of state regulation of ensuring the uniformity of measurements in the event of approval of the type of reference materials or type of measuring instruments.
2. The type approval mark shall be applied by:

• manufacturers of reference materials and measuring instruments (when releasing reference materials and measuring instruments from production);
• owners of reference materials and measuring instruments (on a voluntary basis in the absence of or damage to the type approval mark, during the shelf life of the reference material or the service life of the measuring instrument).

3. The basis for applying the type approval mark shall be:

• an order of the Federal Agency for Technical Regulation and Metrology on approval of the type of reference materials or type of measuring instruments;
• the availability of information on the approved type of reference materials or type of measuring instruments in the Federal Information Fund for Ensuring the Uniformity of Measurements.

4. The type approval mark shall be applied in the places provided for upon approval of the type of reference material or type of measuring instrument, during the validity period of the approved type of reference materials or type of measuring instruments (when releasing reference materials and measuring instruments of serial production from production), or during the shelf life of the reference material or the service life of the measuring instrument. Upon expiry of the validity period of the approved type of reference material or type of measuring instrument, the application of the type approval mark when releasing reference materials and measuring instruments from production shall be prohibited.
5. The type approval mark shall be applied to:

• each specimen of measuring instruments of the approved type;
• the accompanying documents for such measuring instruments;
• the accompanying documents for reference materials of the approved type.

6. If the design features of the measuring instrument do not allow the mark to be applied directly to it, it shall be applied to the accompanying documents (operating manual, form, passport of the measuring instrument).
7. The accompanying documents for reference materials or measuring instruments marked with the type approval mark shall indicate the registration number of the type of reference materials or type of measuring instruments in the Federal Information Fund for Ensuring the Uniformity of Measurements.
8. If specific units of measuring instruments do not correspond to the approved type or if they can be used for a different purpose that allows for such non-conformity, the marking of measuring instruments with the type approval mark shall not be carried out.
9. The type approval mark must correspond to the diagram shown below.

 

10.  The type approval mark shall be applied fully in accordance with its diagram. It is not permitted to apply individual elements of the diagram separately.
11. The type approval mark must be applied in such a way as to ensure its visibility and distinguishability against the background surface (the image must be contrasting to the background surface on which it is applied).