Measuring instrument

Each medical device (hereinafter referred to as MD) undergoes a testing stage during state registration. One of these is testing for the purpose of approving the type of measuring instruments (hereinafter referred to as the MD type).

Measuring instrument (hereinafter referred to as MI) is a technical means intended for measurement, having standardized metrological characteristics, reproducing and (or) storing a unit of physical quantity, the size of which is assumed to be unchanged (within the established error) over a known period of time.

Figure 1 – Example of a measuring instrument “Temperature indicator for monitoring cold chain parameters”

The list of measurements when carrying out activities in healthcare is presented in the Decree of the Government of the Russian Federation of November 16, 2020 N 1847 "On approval of the list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements". The most common measurements are: measuring human body temperature by contact method (electronic thermometer), measuring the patient's weight and height (medical floor scales with a height meter), measuring the optical and physical characteristics of sets of trial spectacle lenses, non-invasive measurement of blood pressure (tonometer).

Testing for the purpose of type approval of measuring instruments

A type of measuring instrument is a set of measuring instruments intended to measure the same quantities.

 

Figure 2 – Scheme of testing for the purpose of type approval of measuring instruments.

Step 1. Selecting a testing laboratory

The testing laboratory must be accredited in the national accreditation system. Its accreditation area must include the ability to certify methods and metrological expertise of the required measurement parameters (temperature, height, mass, pressure, etc.). All this information is posted on the website of the Federal Accreditation Service (FAS).

Figure 3 – Stages of searching for a testing laboratory on the FAS website.

Stage 2. Preparation of a package of documents

After selecting a testing laboratory, the manufacturer or the manufacturer’s authorized representative provides the laboratory with the following set of documents:

1) Application for testing for the purpose of type approval of measuring instruments;

2) Operation manual;

3) Power of attorney from the manufacturer to the authorized representative of the manufacturer;

4) Photo images of each product model.

The laboratory analyzes these documents and specifies the cost of testing. The cost of testing depends on the scope and parameters of testing. After payment for testing, the manufacturer or the authorized representative of the manufacturer provides the laboratory with samples of all models of MD that are planned for registration.

Stage 3. Coordination of the test program

After receiving the samples, the laboratory prepares a testing program that includes:

1. Test object;

2. Content and scope of tests;

3. Test methods (techniques);

4. Test conditions;

5. The number of serially produced samples of measuring instruments submitted for testing;

6. Algorithms for processing the results obtained during testing.

Important: If the product includes several types of measurements, for example, a patient monitor (measuring body temperature, measuring blood pressure, measuring the volume of inhaled/exhaled air), then it is necessary to describe the test procedure for each measurement parameter.

Stage 4.1. Conducting tests

After the program has been approved, the laboratory begins testing the product. If the tests are successfully completed, the laboratory issues the following set of documents:

1. Draft description of the MI type;

2. Verification methodology;

3. Act, program and protocol of tests.

If the test results show that the product does not meet the stated accuracy, the laboratory requests samples from a new batch or corrects the defect in the samples already provided.

Stage 4.2. Conducting tests and issuing documents for the RZN

The testing process is similar to paragraph 4.1, but at this stage the testing of the measuring instrument can be completed without approval of the measuring instrument type and entry into the ARSHIN system. The act, program and protocol are provided to the RZN.

Stage 5. Conducting an examination at the Federal State Budgetary Institution “VNIIMS”

After stage 4.1, the set of documents is transferred to the Federal State Budgetary Institution "VNIIMS", which carries out an examination of the received materials and, based on the results, prepares a conclusion on the test results. In case of comments from the Federal State Budgetary Institution "VNIIMS", the documents are sent for revision. After revision, the process is repeated.

Stage 6. Entering data into the ARSHIN system

If the conclusion is positive, the set of documents is transferred to Rosstandart. If desired, the manufacturer can request a paper version of the certificate. The entire process of testing and entering into the FGIS "ARSHIN" takes 4-6 months, depending on the scope of work. In parallel with entering into the state register, the act, program and protocol can be submitted to RZN as part of the registration dossier.

 

Figure 4 – Test options

Stage 7. Verification of measuring instruments

Before releasing a manufactured and imported batch of products into circulation, it must be sent for primary verification. Verification of measuring instruments is the determination by the metrological body of the errors of measuring instruments (or verification of their compliance with permissible standards) and the establishment of their suitability for use. Verification is carried out for a batch of medical products in accordance with the established verification methodology, in an accredited testing laboratory.

A distinction is made between primary and secondary (repeated) verification of measuring instruments. Primary verification is testing a new measuring instrument or after repair, maintenance, adjustment, as well as when importing a measuring instrument from abroad for sale. Secondary verification is a procedure carried out on measuring instruments in operation or in storage after the inter-verification intervals established for the measuring instrument. Based on the verification results, each serial number of the product from the verified batch is entered into the FGIS "ARSHIN".

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1. Russian Federation. Government. "On approval of the list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements": Resolution of the Government of the Russian Federation of November 16, 2020 No. 1847 (with amendments and additions);
2. Federal State Information System of Rosstandart.