Recommendation of the Board of the Eurasian Economic Commission Dated September 4, 2017, No. 17

N (No.)

Standard Reference

Standard Name

Date of Implementation

Date of Discontinuation

Applicable Structural Elements of the Standard

Paragraph of General Requirements

1 

2 

3 

4 

5 

6 

7 

I. Standards applicable to medical devices (excluding in vitro diagnostics)

1 

GOST 28271-89 

Portable radiometric and dosimetric instruments. General technical requirements and trial methods

06.05.2017 

1.1.4 - 1.1.8, 1.3.1, 1.3.2 

3 

1.1.4 - 1.1.8, 1.3.1, 1.3.2 

4 

1.1.4 - 1.1.8, 1.3.1, 1.3.2 

6 

1.1.4 - 1.1.8, 1.3.1, 1.3.2 

7 

1.1.4 - 1.1.8, 1.3.1, 1.3.2 

8 

2.1 - 2.10 

31 

2.1 - 2.10 

32 

2.1 - 2.10 

33 

2 

GOST 21643-2022 

Medical staplers. General specifications

01.12.2023 

3.2, 3.6 - 3.21, 5.6 - 5.19 

3 

3.26, 5.24 

5 

3.2, 3.6 - 3.21, 5.6 - 5.19 

6 

3.27, 3.28 

7 

3.4, 3.5, 5.4, 5.5 

12 

(Item 2 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023N 15)

3 - 4 

Excluded. - Recommendation of the Board of the Eurasian Economic Commission dated 06.08.2021 N 10

5 

GOST Р 58236-2020 

Elastic compression medical devices. General technical requirements. Trial methods

01.08.2021 

5, 6 

3 

5, 6 

4 

5, 6 

5 

5, 6 

6 

5, 6 

7 

5, 6 

8 

5, 6 

12 

(Item 5 amended by the recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10)

6 

GOST 31515.3-2012
(EN 1060-3:1997, MOD) 

Non-invasive sphygmomanometers (blood pressure meters). Part 3. Supplementary requirements for electromechanical blood pressure measuring systems

06.05.2017 

7, 8 

3 

7, 8 

4 

7.5.1, 7.5.2, 8.9 

5 

7, 8 

6 

7.6, 8.1 

7 

7, 8 

8 

9 

9 

9.1 

11 

7.3 

23 

7.8, 8.11, 9.2 

27 

7.4, 7.5, 7.11, 8.4 - 8.7, 8.9 

28 

7.2, 7.6, 7.9, 8.1, Приложение A 

31 

7.7 

32 

6 

33 

7.3, 8.2 

38 

7.1 

41 

7.1 

42 

7.8, 7.11.3, 8.11 

49 

9.2 

54 

9.1, 9.3 

58 

9.2 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

7 

GOST 31576-2012 

Biological evaluation of medical dental materials and devices. Classification and preparation of samples

06.05.2017 

3 

13 

3 

15 

8 

GOST 31589-2012
(ISO 12870:1997, MOD) 

Ophthalmic optics. Spectacle frames. General requirements and trial methods

06.05.2017 

4 - 6 

3 

4 - 6 

4 

4 - 6 

5 

4 - 6 

6 

4 - 6 

7 

4 - 6 

8 

4 - 6 

9 

4 - 6 

12 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

9 

GOST 31620-2012 

Surgical suture materials. General technical requirements. Trial methods

06.05.2017 

6.2 - 6.6 

3 

6.2 - 6.6 

6 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

10 

GOST EN 556-1-2011
(EN 556-1:2001, IDT) 

Sterilization of medical devices. Requirements for medical devices to be designated "sterile". Part 1. Requirements for medical devices that are terminally sterilized

06.05.2017 

4.1 

3 

4.1 

16 

4.2 

19 

4.1 

58 

11 

GOST IEC 60522-2011
(IEC 60522:1999, IDT)

Diagnostic X-ray tubes. Methods of determining the continuous radiation filtration

06.05.2017 

4, 5 

3 

4, 5 

4 

4, 5 

6 

4, 5 

8 

12 

GOST IEC 60580-2011 (IEC 60580:2000, IDT) 

Medical electrical equipment. Dose area product meters

06.05.2017 

4, 5, 6 

31 

4, 5, 6 

32 

4, 5, 6 

33 

13 

GOST IEC 60601-2-22-2011
(IEC 60601-2-22:2007, IDT) 

Medical electrical equipment. Part 2-22. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

06.05.2017 

201.4 - 201.17 

3 

201.4 - 201.17 

4 

201.4 - 201.17 

5 

201.4 - 201.17 

6 

201.4 - 201.17 

7 

201.4 - 201.17 

8 

201.11 

12 

201.11 

14 

201.11 

15 

201.15 

26 

201.16 

27 

201.9, 201.11 - 201.13, 201.15, 201.17 

28 

201.11 

29 

201.7 

30 

201.12 

31 

201.10 

34 

201.10 

35 

201.10 

36 

201.10 

37 

201.14 

38 

201.13 

39 

201.12 

42 

201.17 

43 

201.17 

44 

201.8 

45 

201.9 

46 

201.9 

47 

201.9 

48 

201.8, 201.15 

49 

201.15 

50 

201.11 

51 

201.12, 201.15 

52 

201.12, 201.15 

53 

201.12 

54 

201.7 

58 

201.7 

65 

14 

GOST IEC 60825-1-2013
(IEC 60825-1:2007, IDT) 

Safety of laser products. Part 1. Equipment classification, requirements and manual

06.05.2017 

4 - 6, 7.2, 8, 9 

34 

4 - 6, 7.2, 8, 9 

35 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

15 

GOST ISO 10555-1-2021,
(ISO 10555-1:2013 + Amd.1:2017, IDT) 

Sterile single-use intravascular catheters. Part 1. General requirements.

01.12.2023 

4, 5 

3 

4, 5 

4 

4, 5 

5 

4, 5 

6 

4, 5 

7 

4, 5 

12 

4, 5 

13 

5, 6 

27 

4, 5 

28 

(Item 15 amended by the recommendation of the Board of the Eurasian Economic Commission dated 06.27.2023 N 15)

16 

GOST ISO 10555-5-2021
(ISO 10555-5:2013, IDT) 

Sterile single-use intravascular catheters. Part 5. Peripheral catheters with integral needle

01.12.2023 

4, appendix A - D 

3 

4, appendix A - D 

4 

4, appendix A - D 

5 

4, appendix A - D 

6 

4, appendix A-D

7 

4, appendix A - D 

12 

4, appendix A - D 

13 

4, appendix A - D 

27 

4, appendix A - D 

28 

(Item 16 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

17 

GOST ISO 10993-11-2021
(ISO 10993-11:2017, IDT) 

Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity effects

01.12.2023 

4 - 6 

12 

4 - 6 

13 

4 - 6 

15 

(Item 17 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

18 

GOST ISO 10993-1-2021
(ISO 10993-1:2018, IDT) 

Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process.

01.12.2023 

5 - 7 

12 

4 - 7 

13 

4 - 7 

15 

(Item 18 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

19 

GOST ISO 10993-12-2015
(ISO 10993-12:2012, IDT) 

Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

06.05.2017 

4 - 11 

13 

4 - 11 

15 

20 

Excluded. - Recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10

21 

GOST ISO 10993-13-2016
(ISO 10993-13:2010, IDT) 

Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

01.01.2018 

4 - 6 

12 

4 - 6 

13 

4 - 6 

15 

22 

GOST ISO 10993-14-2011
(ISO 10993-14:2001, IDT) 

Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics

06.05.2017 

4 - 6 

12 

4 - 6 

13 

4 - 6 

15 

23 

GOST ISO 10993-15-2011
(ISO 10993-15:2000, IDT) 

Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys

06.05.2017 

4 - 9 

12 

4 - 9 

13 

4 - 9 

15 

24 

Excluded. - Recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10

25 

GOST ISO 10993-16-2021
(ISO 10993-16:2017, IDT) 

Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

01.12.2023 

4, 5, appendix A 

12 

4, 5, appendix A 

13 

4, 5, appendix A 

15 

(Item 25 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

26 

GOST ISO 10993-17-2011
(ISO 10993-17:2002, IDT) 

Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances

06.05.2017 

4 - 10 

12 

4 - 10 

13 

4 - 10 

15 

27 

GOST ISO 10993-18-2011
(ISO 10993-18:2005, IDT) 

Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials

06.05.2017 

5 - 8, Appendix A 

12 

5 - 8  Appendix A 

13 

5 – 8 Appendix A 

15 

28 

GOST ISO 10993-3-2018
(ISO 10993-3:2014, IDT) 

Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

01.08.2021 

4 - 7 

12 

4 - 7 

13 

4 - 7 

15 

(Item 28 amended by the recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10)

29 

GOST ISO 10993-4-2020
(ISO 10993-4:2017, IDT) 

Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for devices in contact with blood

01.12.2023 

6 

12 

6 

13 

6 

15 

(Item 29 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

30 

GOST ISO 10993-5-2011
(ISO 10993-5:1999, IDT) 

Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity

06.05.2017 

4 - 10 

12 

4 - 10 

13 

4 - 10 

15 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

31 

GOST ISO 10993-6-2021
(ISO 10993-6:2016, IDT) 

Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation

01.12.2023 

4, 5,  appendex A, B, C, D 

12 

4, 5, appendix A, B, C, D 

13 

4, 5, appendix A, B, C, D 

15 

(Item 31 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

32 

Excluded. - Recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10

33 

GOST ISO 10993-7-2016
(ISO 10993-7:2008, IDT) 

Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

01.01.2018 

4, 5 

13 

4, 5 

15 

34 

GOST ISO 10993-9-2015 (ISO 10993-9:2009, IDT) 

Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

06.05.2017 

4, 5, Appendix A 

12 

4, 5, Appendix A 

13 

4, 5, Appendix A 

15 

35 

GOST ISO 11135-2017
(ISO 11135:2014, IDT) 

Sterilization of  medical devices. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices

01.08.2021 

4 - 12 

18 

4 - 12 

19 

(Item 35 amended by the recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10)

36 

GOST ISO 11137-1-2011
(ISO 11137-1:2006, IDT) 

Sterilization of medical devices. Radiation sterilization. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

06.05.2017 

4 - 12 

18 

4 - 12 

19 

37 

GOST ISO 11137-2-2011
(ISO 11137-2:2006, IDT) 

Sterilization of medical devices. Radiation sterilization. Part 2. Establishing the sterilizing dose

06.05.2017 

4 - 10 

18 

4 - 10 

19 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

38 

GOST ISO 11138-1-2012
(ISO 11138-1:1994, IDT) 

Sterilization of medical devices. Biological indicators. Part 1. General requirements

06.05.2017 

4 - 5, Appendix A 

3 

4 - 5, Appendix A 

5 

4 -5, Appendix A 

6 

4 - 5, Appendix A 

9 

4 - 5, Appendix A 

11 

4 - 5, Appendix A 

13 

4 - 5, Appendix A 

14 

4 - 5, Appendix A 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

39 

GOST ISO 11138-2-2012
(ISO 11138-2:1994, IDT) 

Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization

06.05.2017 

4 - 7 

3 

4 - 7 

5 

4 - 7 

6 

4 - 7 

9 

4 - 7 

11 

4 - 7 

13 

4 - 7 

14 

4 - 7 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

40 

GOST ISO 11138-3-2012
(ISO 11138-3:1994, IDT) 

Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization

06.05.2017 

4 - 10, Appendix A 

3 

4 – 10, Appendix A 

5 

4 - 10, Appendix A 

6 

4 - 10, Appendix A 

9 

4 - 10, Appendix A 

11 

4 - 10, Appendix A 

13 

4 - 10, Appendix A 

14 

4 - 10, Appendix A 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

41 

GOST ISO 11140-1-2011
(ISO 11140-1:2005, IDT) 

Sterilization of health care products. Chemical indicators. Part 1. General requirements

06.05.2017 

4.2 - 4.7, 5.5, 6.1, 8 

3 

4.2 - 4.7, 5.5, 6.1, 8 

5 

4.2 - 4.7, 5.5, 6.1, 8 

6 

5.8 

9 

5.8 

11 

4.2 - 4.7, 5.5, 6.1, 8 

13 

4.2 - 4.7, 5.5, 6.1, 8 

14 

4.2 - 4.7, 5.5, 6.1, 8 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

42 

GOST ISO 11140-3-2011
(ISO 11140-3:2000, IDT) 

Sterilization of health care products. Chemical indicators. Part 3. Class 2 indicator test sheets for use in steam penetration tests

06.05.2017 

4.1, 6, 7, 8.1 

3 

4.1, 6, 7, 8.1 

5 

4.1, 6, 7, 8.1 

6 

4.1, 6, 7, 8.1 

9 

4.1, 6, 7, 8.1 

11 

4.1, 6, 7, 8.1 

13 

4.1, 6, 7, 8.1 

14 

4.1, 6, 7, 8.1 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

43 

GOST ISO 11737-1-2012 (ISO 11737-1:1995, IDT) 

Sterilization of medical devices. Microbiological methods. Part 1. Evaluation of a population of microorganisms on products

06.05.2017 

4 - 8 

19 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

44 

GOST ISO 11737-2-2011 (ISO 11737-2:1998, IDT) 

Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

06.05.2017 

4 - 7 

19 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

45 

GOST ISO 13485-2017
(ISO 13485:2016, IDT) 

Medical devices. Quality management systems. Requirements for regulatory purposes

01.08.2021 

4.1, 4.2, 5.1, 5.3 - 5.6, 6.4, 7.1 - 7.6, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1 - 8.5.3 

3 

4.1, 4.2, 5.1, 5.3 - 5.6, 6.4, 7.1 - 7.6, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1 - 8.5.3 

4 

4.1, 4.2, 5.1, 5.3 - 5.6, 6.4, 7.1 - 7.6, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1 - 8.5.3 

5 

4.1, 4.2, 5.1, 5.3 - 5.6, 6.4, 7.1 - 7.6, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1 - 8.5.3 

6 

4.1, 4.2, 5.1, 5.3 - 5.6, 6.4, 7.1 - 7.6, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1 - 8.5.3 

7 

4.1, 4.2, 5.1, 5.3 - 5.6, 6.4, 7.1 - 7.6, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1 - 8.5.3 

8 

(Item 45 amended by the recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10)

46 

GOST ISO 14160-2011
(ISO 14160:1998, ЮТ) 

Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants

06.05.2017 

4 - 7 

18 

4 - 7 

19 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

47 

GOST ISO 14971-2021
(ISO 14971:2019, IDT) 

Medical devices. Application of risk management to medical devices

01.12.2023 

4 - 10 

3 

4 - 10 

4 

4 - 10 

5 

4 - 10 

7 

4 - 10 

8 

(Item 47 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

48 

GOST ISO 7864-2011
(ISO 7864:1993, IDT) 

Sterile single-use injection needles

06.05.2017 

4 - 15 

3 

4 - 15 

4 

14 

5 

4 - 15 

6 

8, 15 

9 

4 - 13 

12 

4 - 13 

14 

5, 6, 14 

15 

10, 14 

16 

10, 14 

18 

7 - 9, 13 

27 

7, 8, 12, 13, 15 

28 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

49 

GOST ISO 7886-1-2011
(ISO 7886-1:1993, IDT) 

Sterile single-use injection syringes. Part 1. Syringes for manual use

06.05.2017 

5 - 14 

3 

12 - 14 

4 

15 

5 

12, 14, 15 

6 

16 

9 

16 

11 

5, 6, 7, 8 

12 

5 - 8, 15 

13 

5 - 8, 14 

15 

14 

16 

15 

18 

13 

27 

9 - 11, 14.1 

31 

10, 11.1, 11.2, 12.1, 12.3 

32 

9, 10, 14.1 

33 

12.2 

52 

12.1, 12.2, 14 

53 

16 

58 

15.1, 15.2 

60 

16 

65 

50 

GOST ISO 7886-3-2011 (ISO 7886-3:2005, IDT) 

Sterile single-use injection syringes. Part 3. Auto-disable syringes for fixed-dose immunization

06.05.2017 

5, 6, 7, 8, 10, 11.1, 12.1, 12.2, 13.1, 13.2, 14.1, 14.2, 14.3 

3 

12.1, 12.2, 13.1, 13.2, 14.1, 14.2, 14.3 

4 

14.4 

5 

12.1, 12.2, 14.3, 15.1 

6 

16 

9 

16 

11 

5, 6, 7, 8 

12 

5, 6, 7, 8, 15.1, 15.2 

13 

5, 6, 7, 8, 14.2 

15 

14.3 

16 

15.1, 15.2 

18 

13.2 

27 

9, 10, 11.1, 14.1 

31 

10, 11.1, 11.2, 12.1, 12.3 

32 

9, 10, 14.1 

33 

12.2 

52 

12.1, 12.2, 14.3 

53 

16 

58 

15.1, 15.2 

60 

16 

65 

51 

GOST ISO 7886-4-2011
(ISO 7886-4:2006, IDT) 

Sterile single-use injection syringes. Part 4. Syringes with reuse-prevention feature

06.05.2017 

6 - 15 

3 

13 - 15 

4 

16 

5 

13, 15, 16 

6 

17 

9 

17 

11 

6 - 9 

12 

6 - 9, 16 

13 

6 - 9, 15 

15 

15 

16 

16 

18 

14 

27 

10 - 12, 15.1 

31 

11, 12, 13 

32 

10, 11 

33 

13 

52 

13, 15 

53 

17 

58 

16 

60 

17 

65 

52 

GOST ISO 8537-2011
(ISO 8537:2007, IDT) 

Sterile single-use injection syringes, with or without needle, for insulin. Requirements and trail methods

06.05.2017 

4 - 14, Appendix A - I 

3 

4 - 14, Appendix A - I 

4 

4 - 15 

5 

4 - 14, Appendix A - I 

6 

16 

9 

16 

11 

4 - 14, Appendix A - I 

12 

4 - 14, Appendix A - I 

13 

4 - 14, Appendix A - I 

15 

4 - 14, Appendix A - I 

16 

15 

18 

4 - 14, Appendix A - I 

27 

9 

32 

4 - 14, Appendix A - I 

52 

4 - 14, Appendix A - I 

53 

16 

58 

16 

60 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

53 

GOST ISO 9801-2011
(ISO 9801:1997, IDT) 

Trial lens sets. Technical requirements and trial methods

06.05.2017 

4, 5 

3 

4, 5 

4 

4, 5 

6 

4, 5 

7 

4, 5 

8 

4.2, 5.1 

31 

4.2, 5.1 

32 

4.2, 5.1 

33 

6 

58 

7 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

54 

GOST ISO/TS 10993-19-2011
(ISO/TS 10993-19:2006, IDT) 

Medical devices. Biological evaluation of medical devices. Part 19. Physico-chemical, morphological and topographical characterization of materials

06.05.2017 

5 - 8 

8 

5 - 8 

15 

55 

GOST ISO/TS 10993-20-2011
(ISO/TS 10993-20:2006, IDT) 

Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicity testing of medical devices

06.05.2017 

4 - 7 

8 

4 - 7 

15 

56 

GOST OIML R 76-1-2011
(OIML R76-1:2006, IDT) 

State system for ensuring the uniformity of measurements. Non-automatic weighing instruments. Part 1. Metrological and technical requirements. Trials

06.05.2017 

Appendix A 

31 

Appendix A 

32 

Appendix  A 

33 

57 

GOST R ISO 14644-1-2017
(ISO 14644-1:2015, IDT) 

Cleanrooms and associated controlled environments. Part 1. Classification of air cleanliness by particle concentration

01.08.2021 

4, 5, Appendix А 

20 

(Item 57 amended by the recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10)

58 

GOST ISO 14698-1-2005
(ISO 14698-1:2003, IDT) 

Cleanrooms and associated controlled environments. Biocontamination control. Part 1. General principles and methods

06.05.2017 

4 - 9 

20 

59 

GOST ISO 14698-2-2005
(ISO 14698-2:2003, IDT) 

Cleanrooms and associated controlled environments. Biocontamination control. Part 2. Analyzing biocontamination data

06.05.2017 

4 

20 

60 

GOST R 50267.2.54-2013
(IEC 60601-2-54:2009, MOD) 

Medical electrical equipment. Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

06.05.2017 

201.4 - 201.17, 202, 203 

3 

201.4 - 201.17, 202, 203 

4 

201.4 - 201.17, 202, 203 

5 

201.4 - 201.17, 202, 203 

6 

201.4 - 201.17, 202, 203 

7 

201.4 - 201.17, 202, 203 

8 

201.11 

12 

201.11 

14 

201.11 

15 

201.15 

26 

201.16 

27 

201.9, 201.11 - 201.13, 201.15, 201.17, 202 

28 

201.11 

29 

201.7 

30 

201.12 

31 

201.10, 203 

34 

201.10, 203 

35 

201.10 

36 

201.10, 203 

37 

201.14 

38 

201.13 

39 

201.12 

42 

201.17, 202 

43 

201.17, 202 

44 

201.8 

45 

201.9 

46 

201.9 

47 

201.9 

48 

201.8, 201.15 

49 

201.15 

50 

201.11 

51 

201.12, 201.15 

52 

201.12, 201.15 

53 

201.12 

54 

201.7 

58 

201.7 

65 

61 

GOST R 52459.27-2009
(EN 301 489-27:2004, MOD) 

Electromagnetic compatibility of technical equipment. Radio communication equipment. Part 27. Particular requirements for active implantable medical devices with extremely low power and associated peripheral devices

06.05.2017 

4 - 7 

28 

4 - 7 

43 

4 - 7 

44 

62 

GOST R 52459.31-2009
(EN 301 489-31:2005, MOD) 

Electromagnetic compatibility of technical equipment. Radio communication equipment. Part 31. Particular requirements for radio equipment for active implantable medical devices with extremely low power and associated peripheral devices, operating in the frequency range from 9 to 315 kHz

06.05.2017 

4 - 7 

28 

4 - 7 

43 

4 - 7 

44 

63 

Excluded. - Recommendation of the Board of the Eurasian Economic Commission dated08.06.2021 N 10

64 

GOST R 52770-2016 

Medical devices. Safety requirements. Methods of sanitary-chemical and toxicological trials

01.10.2017 

4.1 - 4.5, 5, 6, Appendix А, Б, В 

13 

4.1 - 4.5, 5, 6, Appendix А, Б, В 

15 

65 

GOST R 53469-2009 (ISO 8600-1:2005, MOD) 

Optics and optical instruments. Endoscopes and endotherapeutic medical devices. Part 1. General requirements

06.05.2017 

5.2 - 5.6 

3 

5.2 - 5.6 

6 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

66 

GOST R 54794-2011 

Ethanol vapor analyzers. General technical conditions

06.05.2017 

5.2.1 - 5.2.3, 5.3, 7.4, 8.1, 8.3 - 8.5, 8.8, 9.1, 10, Appendix А 

3 

5.2.1 - 5.2.3, 5.3, 7.4, 8.1, 8.3 - 8.5, 8.8, 9.1, 10, Appendix А 

4 

5.2.1 - 5.2.3, 5.3, 7.4, 8.1, 8.3 - 8.5, 8.8, 9.1, 10, Appendix А 

5 

5.2.1 - 5.2.3, 5.3, 7.4, 8.1, 8.3 - 8.5, 8.8, 9.1, 10, Appendix А 

6 

5.2.1 - 5.2.3, 5.3, 7.4, 8.1, 8.3 - 8.5, 8.8, 9.1, 10, Appendix А 

7 

5.2.1 - 5.2.3, 5.3, 7.4, 8.1, 8.3 - 8.5, 8.8, 9.1, 10, Appendix А 

8 

5.2.1 

31 

5.2.1 

32 

5.2.1 

33 

10 

65 

67 

GOST R 8.605-2004
(IEC/TR 61206:1993, MOD) 

State system for ensuring the uniformity of measurements. Medical ultrasonic diagnostic devices. General requirements for methods of measuring parameters of continuous wave Doppler devices

06.05.2017 

4, 5 

3 

4, 5 

32 

4, 5 

38 

4, 5 

52 

4, 5 

53 

4, 5 

54 

68 

GOST R ISO 10328-2021
(ISO 10328:2016, IDT) 

Prostheses. Testing the design of lower limb prostheses. Requirements and trials methods

01.12.2023 

4 - 16 

3 

4 - 16 

4 

4 - 16 

5 

4 - 16 

6 

4 - 16 

7 

(Item 68 amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

69 

GOST R ISO 10651-4-2015
(ISO 10651-4:2002, IDT) 

Medical lung ventilators. Part 4. Particular requirements for basic safety and essential performance of manually powered resuscitators

06.05.2017 

4 - 10 

3 

4 - 10 

4 

5.4, 5.5, 7.1 

5 

4.1 - 4.3, 4.5 - 4.7, 5.2 - 5.4, 6.1 - 6.7, 7.1, 7.2 

6 

5.1 - 5.5, 7.1 

7 

9.1 

8 

70 

GOST R ISO 10993-2-2009
(ISO 10993-2:2006, IDT) 

Medical devices. Biological evaluation of medical devices. Part 2. Requirements for the treatment of animals. 

06.05.2017 

4.5, 4.8 "a", "b", "c", "d1", "d2", "d8" 

3 

4.5, 4.8 "a", "b", "c", "d1", "d2", "d8" 

6 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

71 

GOST R ISO 11334-1-2010
(ISO 11334-1:2007, IDT) 

Walking aids manipulated by one arm. Requirements and trials methods. Part 1. Elbow crutches

06.05.2017 

4, 5 

3 

4, 5 

4 

4, 5 

5 

4, 5 

6 

4, 5 

7 

4, 5 

8 

6 

9 

4, 5 

12 

4, 5 

46 

4, 5 

55 

4, 5 

56 

4, 5 

57 

6 

58 

6 

65 

72 

GOST R ISO 12866-2011
(ISO 12866:1999, IDT) 

State system for ensuring the uniformity of measurements. Ophthalmic perimeters. Technical requirements and trials methods

06.05.2017 

4.2 - 4.4, 5 

3 

4.2 - 4.4, 5 

4 

4.2 - 4.4, 5 

6 

4.2 - 4.4, 5 

8 

4.2 - 4.4, 5 

31 

4.2 - 4.4, 5 

32 

73 

GOST R ISO 13408-1-2000
(ISO 13408-1:1998, IDT) 

Aseptic manufacturing of health care products. Part 1. General requirements

06.05.2017 

3 - 21 

18 

3 - 21 

19 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

74 

GOST R ISO 13408-2-2007
(ISO 13408-2:2003, IDT) 

Aseptic manufacturing of health care products. Part 2. Filtration

06.05.2017 

4 - 12 

18 

4 - 12 

19 

75 

GOST R ISO 13408-3-2011
(ISO 13408-3:2006, IDT) 

Aseptic manufacturing of health care products. Part 3. Lyophilization

06.05.2017 

4 - 9 

18 

4 - 9 

19 

76 

GOST R ISO  13408-4-2011
(ISO 13408-4:2005, IDT) 

Aseptic manufacturing of health care products. Part 4. Clean-in-place

06.05.2017 

4 - 9 

18 

4 - 9 

19 

77 

GOST R ISO 13408-5-2011
(ISO 13408-5:2006, IDT) 

Aseptic manufacturing of health care products. Part 5. Sterilize-in-place

06.05.2017 

4 - 9 

18 

4 - 9 

19 

78 

GOST R ISO 13408-6-2009
(ISO 13408-6:2005, IDT) 

Aseptic manufacturing of health care products. Part 6. Isolator systems

06.05.2017 

4 - 9 

18 

4 - 9 

19 

79 

GOST R ISO 14155-2022 (ISO 14155:2020, IDT) 

Clinical investigations of medical devices for human subjects - Good clinical practice

31.03.2025 

4 - 10, Appendix A, H, I 

3 

4 - 10, Appendix A, H, I 

6 

4 - 10, Appendix A, H, I 

8 

(Item 79 amended by the recommendation of the Board of the Eurasian Economic Commission dated 11.02.2025 N 2)

80 

GOST R ISO 14630-2017
(ISO 14630:2012, IDT) 

Non-active surgical implants. General requirements

01.08.2021 

4 - 8 

3 

4 - 8 

4 

4, 5, 7, 8, 10 

5 

4 - 10 

6 

4 - 8 

7 

5, 7 

8 

4 - 8 

12 

4, 6 - 8, 10 

13 

6, 7, 8 

14 

9, 10 

16 

9, 10 

18 

9, 10 

19 

9, 10 

20 

9, 10 

21 

6 

22 

6 

23 

5, 6, 11 

27 

4, 5, 6 

28 

9 

58 

9, 10 

60 

(Item 80 amended by the recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10)

81 

GOST R ISO 14937-2012
(ISO 14937:2009, IDT) 

Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

06.05.2017 

4 - 12 

18 

4 - 12 

19 

82 

GOST R ISO 15032-2001
(ISO 15032:2000, IDT) 

Prostheses. Testing the design of hip joints

06.05.2017 

4 - 9 

3 

4 - 9 

4 

4 - 9 

5 

4 - 9 

6 

4 - 9 

7 

4 - 9 

8 

4 - 9 

9 

4 - 9 

12 

83 

GOST R ISO 15223-1-2023 (ISO 15223-1:2021, IDT) 

Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements

31.03.2025 

4 

11 

5.1 - 5.4 

58 

5.2.7 

60 

(Item 83 amended by the recommendation of the Board of the Eurasian Economic Commission dated 11.02.2025 N 2)

84 

GOST R ISO 15882-2012
(ISO 15882:2008, IDT) 

Sterilization of medical devices. Chemical indicators. Guidance for selection, use and interpretation of results

06.05.2017 

3 - 11 

18 

3 - 11 

19 

85 

GOST R ISO 16061-2011
(ISO 16061:2008, IDT) 

Instruments for use in association with non-active surgical implants. General requirement

06.05.2017 

4 - 8 

3 

4 - 8 

4 

4, 5, 7, 8, 10 

5 

4 - 10 

6 

4 - 8 

7 

5, 7 

8 

4 - 8 

12 

4, 6 - 8, 10 

13 

6, 7, 8 

14 

9, 10 

16 

9, 10 

18 

9, 10 

19 

9, 10 

20 

9, 10 

21 

6 

22 

6 

23 

5, 6, 11 

27 

4, 5, 6 

28 

9 

58 

9, 10 

60 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

86 

GOST R ISO 16201-2010
(ISO 16201:2006, IDT) 

Assistive products for persons with disability. Environmental control systems for domestic use

06.05.2017 

4 - 6 

3 

4 - 6 

4 

4 - 6 

5 

4 - 6 

6 

4 - 6 

7 

4.1 

8 

4.3 

12 

4.2, 6 

27 

6 

28 

6 

29 

5.1 

38 

6 

43 

6 

45 

6 

46 

6 

49 

6 

51 

5.2 

54 

87 

GOST R ISO 17664-2012
(ISO 17664:2004, IDT) 

Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices

06.05.2017 

3 - 6 

58 

3 - 6 

65 

88 

GOST R ISO 17665-1-2016
(ISO 17665-1:2006, IDT) 

Sterilization of health care products - Moist heat - Part 1. Requirements for the development, validation and routine control of a sterilization process for medical devices

01.03.2017 

4 - 12 

18 

4 - 12 

19 

89 

GOST R ISO 20857-2016
(ISO 20857:2010, IDT) 

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

01.03.2017 

4 - 12 

18 

4 - 12 

19 

90 

GOST R ISO 21534-2013
(ISO 21534:2007, IDT) 

Surgical implants non-active. Joint replacement implants. Particular requirements

06.05.2017 

4 - 8 

3 

4 - 8 

4 

4, 5, 7, 8, 10 

5 

4 - 10 

6 

4 - 8 

7 

5, 7 

8 

4 - 8 

12 

4, 6 - 8, 10 

13 

6, 7, 8 

14 

9, 10 

16 

9, 10 

18 

9, 10 

19 

9, 10 

20 

9, 10 

21 

6 

22 

6 

23 

5, 6, 11 

27 

4, 5, 6 

28 

9 

58 

9, 10 

60 

9 

65 

91 

GOST R ISO 21535-2020
(ISO 21535:2007 + Amd.1:2016, IDT) 

Surgical implants non-active. Joint replacement implants. Specific requirements for hip joint replacement implants

01.12.2023 

4 - 8 

3 

4 - 8 

4 

4, 5, 7, 8, 10 

5 

4 - 10 

6 

4 - 8 

7 

5, 7 

8 

4 - 8 

12 

4, 6 - 8, 10 

13 

6 - 8 

14 

9, 10 

16 

9, 10 

18 

9, 10 

19 

9, 10 

20 

9, 10 

21 

6 

22 

6 

23 

5, 6, 11 

27 

4, 5, 6 

28 

9 

58 

9, 10 

60 

9 

65 

(Item 91 as amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

92 

GOST R ISO 21536-2013
(ISO 21536:2007, IDT) 

Surgical implants non-active. Joint replacement implants. Specific requirements for knee joint replacement implants

06.05.2017 

4 - 8 

3 

4 - 8 

4 

4, 5, 7, 8, 10 

5 

4 - 10 

6 

4 - 8 

7 

5, 7 

8 

4 - 8 

12 

4, 6 - 8, 10 

13 

6, 7, 8 

14 

9, 10 

16 

9, 10 

18 

8, 9, 10 

19 

8, 9 

20 

9, 10 

21 

6 

22 

6 

23 

5, 6, 11 

27 

4, 5, 6 

28 

9 

58 

9, 10 

60 

9, 11 

65 

93 

GOST R ISO 22442-1-2011
(ISO 22442-1:2007, IDT) 

Medical devices using tissues and their derivatives of animal origin. Part 1. Risk management

06.05.2017 

4.1 - 4.6, Appendix C 

12 

4.1 - 4.6,
Appendix C 

13 

4.1 - 4.6, Appendix C 

16 

4.1 - 4.6,
Appendix C 

23 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated27.06.2023 N 15)

94 

GOST R ISO 22442-2-2011
(ISO 22442-2:2007, IDT) 

Medical devices using tissues and their derivatives of animal origin. Part 2. Control of selection, collection and processing

06.05.2017 

4 - 8, Appendix A 

12 

4 - 8, Appendix A 

13 

4 - 8, Appendix A 

16 

4 - 8, Appendix A 

23 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

95 

GOST R ISO 22442-3-2011
(ISO 22442-3:2007, IDT) 

Medical devices using tissues and their derivatives of animal origin. Part 3. Validation of the elimination and/or inactivation of viruses and agents of transmissible spongiform encephalopathy

06.05.2017 

4 - 9, Appendix A 

12 

4 - 9, Appendix A 

13 

4 - 9, Appendix A 

16 

4 - 9, Appendix A 

23 

96 

GOST R ISO 22523-2007
(ISO 22523:2006, IDT) 

Limb prostheses and external orthoses. Requirements and trials methods

06.05.2017 

4 - 14 

3 

4 - 14 

4 

4 - 14 

5 

4 - 14 

6 

4 - 14 

7 

4 - 14 

8 

13 

9 

5.1, 5.2 

12 

5.2, 13, 14 

13 

5.2.2, 5.4 

14 

5.2, 5.3 

16 

14 

21 

12.1, 13 

27 

7, 9, 11.1, 12.2, 12.3 

28 

5.1, 8.2, 8.4 

29 

8.3 

38 

8.1, 8.2 

40 

7 

43 

8 

45 

11, 12 

46 

6 

47 

6 

48 

8.2, 11.2 

49 

9 

51 

8.5 

53 

13.1, 13.2 

54 

13 

58 

13 

65 

97 

GOST R ISO 22675-2019
(ISO 22675:2016, IDT) 

Prosthetics. Trials of ankle joints and foot joints of lower limb prostheses. Requirements and trial methods

01.08.2021 

5 10, 15, 16, 17 

4 

5 - 10, 15, 16, 17 

7 

5, 20 

9 

5, 20 

27 

5 - 10, 15, 16, 17 

46 

20 

58 

(Item 97 as amended by the recommendation of the Board of the Eurasian Economic Commission dated 08.06.2021 N 10)

98 

GOST R ISO 25424-2013
(ISO 25424:2009, IDT) 

Sterilization of medical devices. Low-temperature steam formaldehyde sterilization. Requirements for development, validation and routine control of the sterilization process

06.05.2017 

4 - 12 

18 

4 - 12 

19 

99 

GOST R ISO 25539-1-2012
(ISO 25539-1:2003, IDT) 

Cardiovascular implants. Intravascular implants. Part 1. Endovascular prostheses

06.05.2017 

4 - 10 

3 

4 - 10 

4 

5, 8, 10.1 

5 

4, 5, 7, 8, 10.1 

6 

4, 5, 7 

7 

7 

8 

4 - 8 

12 

5 - 9, 10.1 

13 

5 - 7, 10.1 

14 

9 

16 

9, 10.1 

18 

9, 10.1 

19 

6, 10.1 

22 

6, 9 

23 

5, 7, 10.2, 10.3 

27 

5, 6, 7 

28 

10.2 

58 

10.2 

60 

10.3 

65 

100 

GOST R ISO 25539-2-2012
(ISO 25539-2:2008, IDT) 

Cardiovascular implants. Intravascular implants. Part 2. Vascular stents

06.05.2017 

4 - 8, 10 - 12 

3 

4 - 8, 10 

4 

4 - 8, 10 - 12 

5 

4 - 8, 10 - 12 

6 

4 - 8, 10 - 12 

7 

6 - 8 

8 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

101 

GOST R ISO 7396-1-2011
(ISO 7396-1:2007, IDT) 

Medical gas pipeline systems. Part 1. Pipeline systems for compressed medical gases and vacuum

06.05.2017 

4, 5.1 - 5.2.7, 6, 7, 8, 11, 12.1 - 12.4 

3 

4, 5.1 - 5.2.7, 5.3.1 - 5.3.4, 5.8 - 5.10, 6, 7, 8, 11, 12.1 - 12.4, 12.6.2 - 12.6.9 

4 

4.4.1, 4.4.2, 5.1 - 5.2.7, 5.2.8, 5.3.1 - 5.3.4, 5.4, 5.5.1, 5.5.2.12, 5.5.2.1 - 5.5.2.10, 5.5.3, 5.6, 5.7.1 - 5.7.7, 5.8 - 5.10, 6, 7, 11, 12.1 - 12.4, 12.6.2 - 12.6.9 

6 

4.4.2, 5.1 - 5.2.7, 6, 7.3, 11, 13, 

7 

13 

9 

4, 4.3.3, 4.3.6, 5.3.7, 5.3.8 

12 

4.3.7, 4.3.8, 5.5.2.1 - 5.5.2.10, 5.5.3, 5.6, 12.6.10, 12.6.11, 12.6.12, 12.6.13, 12.6.14 

13 

4 

14 

4.3.7, 4.3.8, 5.1 - 5.2.7, 5.3.1 - 5.3.4, 5.5.2.11, 5.5.3, 5.6, 5.7.8 - 5.7.9, 12.5.2, 12.6.1, 12.6.2 - 12.6.9 

15 

5.7.1 - 5.7.7 

16 

9 

27 

4.3.4, 4.3.9, 5.5.2.12, 7.2.5, 7.2.6, 9.3, 12.5.1, 12.5.2 

28 

4.3.2, 4.3.4, 4.3.5, 4.3.6, 5.3.7, 5.6, 7.1, 12.5.1, 12.5.2 

29 

6, 9.3, 9.3, 11.1.3, 4.3.4 

41 

9.3 

43 

9.3, 11.1.3 

45 

4.3.4, 4.3.6, 5.3.5, 5.3.6, 7.1, 12.5.1, 12.5.2, 12.6.1 

46 

5.5.2.13, 5.7.10 

47 

12.6.15 - 12.6.16, 9 

49 

5.1 - 5.2.7, 5.7.1 - 5.7.7, 6, 12.6.15 - 12.6.16 

52 

5.1 - 5.2.7, 6 

53 

6 

54 

13 

58 

13, 9 

65 

(amended by the recommendation of the Board of the Eurasian Economic Commission dated 27.06.2023 N 15)

102 

GOST R ISO 80601-2-12-2013
(ISO 80601-2-12:2011, IDT) 

Medical electrical equipment. Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators

06.05.2017 

201.4 - 201.17, 201.101 - 201.108, 202, 206, 208 

3 

201.4 - 201.17, 201.101 - 201.108, 202, 206, 208 

4 

201.7 

5 

201.4 - 201.17, 201.101 - 201.108, 202, 206, 208 

6 

201.12.1, 201.12.4, 201.13, 201.15, 201.102, 201.105 

7 

201.103 

8 

201.7, 201.16 

9 

201.9, 201.11 

12 

201.11 

13 

201.11 

14 

201.11, 201.13 

15 

201.11 

16 

201.11 

20 

201.7 

21 

201.15 

26 

201.8, 201.9, 201.11, 201.14, 201.15, 201.16, 201.101, 201.102, 201.106, 201.108 

27 

201.8, 201.9, 201.12, 201.15, 201.101, 201.106, 201.108, 202, 206 

28 

201.8, 201.11, 201.12, 201.15 

29 

201.7 

30 

201.12 

31 

201.12 

32 

201.7 

33 

201.10, 201.12, 201.17, 202 

34 

201.14 

38 

201.13 

39 

201.11.8 

40 

201.12, 201.11.8 

41 

201.12.4, 201.12, 208 

42 

201.17, 202 

43 

201.17, 202 

44 

201.8, 201.15, 201.16 

45 

201.9, 201.15, 201.16 

46 

201.9, 201.16 

47 

201.9, 201.16 

48 

201.7, 201.8, 201.15, 201.16, 201.101 

49 

201.15 

50 

201.11, 201.15, 201.16 

52 

201.12, 201.101 

53 

201.7 

60 

201.7, 201.16 

65 

103 

GOST R ISO 80601-2-13-2013
(ISO 80601-2-13:2011, IDT) 

Medical electrical equipment. Part 2-13: Particular requirements for the basic safety and essential performance of anaesthetic workstations

06.05.2017 

201.4 - 201.17, 201.101 - 201.107, 202, 203, 206, 208 - 211 

3 

201.4 - 201.17, 201.101 - 201.107, 202, 203, 206, 208 - 211 

4 

201.4 - 201.17, 201.101 - 201.107, 202, 203, 206, 208 - 211 

5 

201.4 - 201.17, 201.101 - 201.107, 202, 203, 206, 208 - 211 

6 

201.4 - 201.17, 201.101 - 201.107, 202, 203, 206, 208 - 211 

7 

201.4 - 201.17, 201.101 - 201.107, 202, 203, 206, 208 - 211 

8 

201.11 

12 

201.11 

14 

201.11 

15 

201.15 

26 

201.16 

27 

201.9, 201.11 - 201.13, 201.15, 201.17, 202, 206 

28 

201.11 

29 

201.7 

30 

201.12 

31 

201.10 

34 

201.10 

35 

201.10 

36 

201.10 

37 

201.14 

38 

201.13 

39 

201.12 

42 

201.17, 202 

43 

201.17, 202 

44 

201.8 

45 

201.9 

46 

201.9 

47 

201.9 

48 

201.8, 201.15 

49 

201.15 

50 

201.11 

51 

201.12, 201.15 

52 

201.12, 201.15 

53 

201.12 

54 

201.7 

58 

201.7 

65 

104 

GOST R ISO 80601-2-55-2015
(ISO 80601-2-55:2011, IDT) 

Medical electrical equipment. Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

06.05.2017 

201.11.6.4 - 201.11.6.6 

13 

201.11.6.4, 201.11.6.8 

14 

201.11.6.4 

15 

201.11.6.6, 201.11.6.7, 201.105 

16 

201.11.6.7 

19 

201.7.2.101, 201.7.2.4.101, 201.7.2.13.101, 201.7.2.17.101, 201.12.1.102, 201.102, 201.103, 208 

27 

201.9, 201.101, 202, 206 

28 

201.11 

29 

201.12.1, 201.101 

31 

201.7, 201.12.1.103, 201.12.1.104, 206, 208 

32 

201.7.4.3 

33 

202 

36 

201.14 

38 

208 

42 

202 

43 

201.8 

45 

201.9 

46 

201.9 

47 

201.9 

48 

201.8, 201.15, 

49 

201.103 

201.11 

51 

201.104 

54 

201.7.9.1 

58 

201.7.2.17.101 

60 

201.7, 201.12 

65 

105 

GOST R IEC 60601-1-2010
(IEC 60601-1:2005, IDT) 

Medical electrical equipment. Part 1: General requirements for basic safety and essential performance

06.05.2017 

4 - 17 

3 

4 - 17 

4 

4 - 17 

5 

4 - 17 

6 

4 - 17 

7 

4 - 17 

8 

11 

12 

11 

14 

11 

15 

15 

26 

16 

27 

9, 11 - 13, 15, 17 

28 

11 

29 

7 

30 

12 

31 

10 

34 

10 

35 

10 

36 

10 

37 

14 

38 

13 

39 

12 

42 

17 

43