Standards developed by MEDITEX company


No.

Standard name

Number and date of the order on approval of national standard

1

GOST R ISO 15225-2014 - Medical devices. Quality management. Medical device nomenclature data structure.

Rosstandart order of September 22, 2014 No. 1161-st

2

GOST R 57184-2016 - Medical electrical equipment. Devices and apparatus for cryoablation. Specifications for governmental purchases.

Rosstandart order of October 21, 2016 No. 1484-st
3
GOST R 57185-2016 - Medical electrical equipment. Infusion pumps. Specifications for governmental purchases.

Rosstandart order of October 21, 2016 No. 1485-st



TO THE BEGINNING

Standard name

Number and date of the order on approval of national standard / introduction of interstate standard

1

GOST 25377-2015 - Needles for injections for repeated use. Specifications.

Rosstandart order of December 02, 2015 No. 2101-st

2

GOST R 57080-2016 - Medical electric equipment. X-ray bone densitometer (absorptiometer). Specifications for governmental purchases.


Rosstandart order of September 19, 2016 No. 1161-st
3 GOST R 57081-2016 - Medical electrical equipment. Universal radiographic digital systems. Specifications for governmental purchases.

Rosstandart order of September 19, 2016 No. 1162-st

4 GOST R 57082-2016 - Medical electrical equipment. Radiology workstation. Specifications for governmental purchases.

Rosstandart order of September 19, 2016 No. 1163-st

5 GOST R 57083-2016 - Medical electrical equipment. X-Ray systems for digital radiography and tomosynthesis. Specifications for governmental purchases.

Rosstandart order of September 19, 2016 No. 1164-st

6 GOST R 57084-2016 - Medical electrical equipment. Flat-panel digital X-Ray detectors. Specifications for governmental purchases.

Rosstandart order of September 19, 2016 No. 1165-st

7 GOST R 57085-2016 - Medical electrical equipment. Computed radiography systems. Specifications for governmental purchases.

Rosstandart order of September 19, 2016 No. 1166-st

8 GOST R 57086-2016 - Medical electrical equipment. Devices for laser lithotripsy. Specifications for governmental purchases.

Rosstandart order of September 19, 2016 No. 1167-st

9 GOST R 15.013–2016 - System of products development and launching into manufacture. Medical devices.

Rosstandart order of September 19, 2016 No. 1168-st

10 GOST R IEC 60601-2-36-2016 - Medical electrical equipment. Part 2-36. Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy.

Rosstandart order of September 19, 2016 No. 1169-st

11 GOST R 57088-2016 Medical electrical equipment. Mobile digital X-ray Unit. Specifications for governmental purchases.

Rosstandart order of September 20, 2016 No. 1171-st

12 GOST R 57089-2016 - Medical electrical equipment. Dental intra-oral general purpose digital X-ray equipment. Specifications for governmental purchases.

Rosstandart order of September 20, 2016 No. 1172-st

13 GOST R 57090-2016 - Medical electrical equipment. Pediatric X-ray equipment for digital radiography. Specifications for governmental purchases.

Rosstandart order of September 20, 2016 No. 1173-st

14 GOST R 57091-2016 - Medical electrical equipment. Medical automatic X-Ray Film Processor for dark room. Specifications for governmental purchases.

Rosstandart order of September 20, 2016 No. 1174-st

15 GOST R 57092-2016 - Medical electrical equipment. Equipment for telemedicine videoconferencing. Specifications for governmental purchases.

Rosstandart order of September 20, 2016 No. 1175-st

16 GOST R IEC 60601-2-16-2016 - Medical electrical equipment. Part 2-16. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.

Rosstandart order of September 28, 2016 No. 1242-st

17 GOST R IEC 60601-2-25-2016 - Medical electrical equipment. Part 2-25. Particular requirements for the basic safety and essential performance of electrocardiographs.

Rosstandart order of September 28, 2016 No. 1243-st

18 GOST 31214-2016 - Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity.

Rosstandart order of October 21, 2016 No. 1483-st

19
GOST R ISO 14708-3-2016 - Implants for surgery. Active implantable medical devices. Part 3. Implantable neurostimulators.

Rosstandart order of October 21, 2016 No. 1487-st

20 GOST R ISO 14708-4-2016 - Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps.

Rosstandart order of October 21, 2016 No. 1488-st

21 GOST R ISO 14708-7-2016 - Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems.

Rosstandart order of October 21, 2016 No. 1489-st

22 GOST R ISO 13022-2016 - Medical products containing viable human cells. Application of risk management and requirements for processing practices.

Rosstandart order of March 01, 2016 No. 102-st

23 GOST ISO 10993-7-2016 - Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals.

Rosstandart order of October 31, 2016 No. 1532-st

24 GOST ISO 10993-13-2016 - Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices.

Rosstandart order of October 31, 2016 No. 1533-st

25 GOST ISO 10993-16-2016 - Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables.

Rosstandart order of October 31, 2016 No. 1534-st

26 GOST R 52770-2016 - Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests.

Rosstandart order of October 31, 2016 No. 1535-st


TO THE BEGINNING

Standard name

Number and date of the order on approval of national standard / introduction of interstate standard


1

GOST R 57155-2016 - Medical electrical equipment. External automatic defibrillators. Specifications for governmental purchases

Rosstandart order of October 13, 2016 No. 1399-st

2

GOST R 57492-2017 - Medical devices. Implantable cardiac pacemakers. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 504-st

3

GOST R 57500-2017 - Medical devices. Implantable infusion pumps. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 512-st

4

GOST R 57496-2017 - Radiopharmaceuticals. General guidance on the organization of production.

Rosstandart order of June 08, 2017 No. 508-st

5

GOST R 57503-2017 - Medical devices. Individual means of patients protection in radiology and nuclear medicine departments. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 515-st

6

GOST R 57493-2017 - Medical devices. Individual means of personnel protection in radiology and nuclear medicine departments. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 505-St

7

GOST R 57630-2017 / IEC / TS 62736-2016 - Ultrasonic devices. Pulse-echo scanners. Simplified methods of testing the constancy of imaging system parameters.

Rosstandart order of August 29, 2017 No. 975-st

8

GOST R 57498-2017 - Medical devices. X-Ray therapy apparatus with anode voltage from 10 kV to 300 kV. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 510-st

9

GOST R IEC 60601-2-17-2017 Medical electrical equipment. Part 2-17. Particular requirements for the basic safety and essential performance of brachytherapy aferloading equipment.


Rosstandart order of August 29, 2017 No. 973-st

10

GOST R IEC 60601-2-8-2017 - Medical electrical equipment. Part 2-8. Particular requirements for the basic safety and essential performance of therapeutic x-ray apparatus with anode voltage from 10 kV to 1 MV.

11

GOST R 57495-2017 - Medical devices. Implantable neurostimulators. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 507-st

12

GOST R 57505-2017 - Medical devices. Cochlear implant system. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 517-st

13

GOST R 57506-2017 - Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 518-st

14

GOST R 57497-2017 - Medical devices. Implantable active devices intended to support circulatory system. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 509-st

15

GOST R 57499-2017 - Rules of production and quality control of radiopharmaceuticals in PET centers in accordance with the rules of good manufacturing practice.

Rosstandart order of June 08, 2017 No. 511-st

16

GOST R 57631-2017 / IEC/TS 62791-2015 - Ultrasonic devices. Pulse-echo scanners. Low reflection spherical phantoms and test methods for monochrome medical ultrasonic apparatus used with different types transducers.

Rosstandart order of August 29, 2017 No. 976-st

17

GOST R 57504-2017 - Medical devices. Syringe infusion pumps. Specifications for governmental purchases.

Rosstandart order of June 08, 2017 No. 516-st

18

GOST R IEC 60601-2-24-2017 - Medical devices. Part 2-24. Particular requirements for the basic safety and essential performance of infusion pumps and controllers.

Rosstandart order of August 29, 2017 No. 974-st

19

GOST R 57629-2017 - Medical devices. General safety requirements and compatibility of single use infusion pipelines.

Rosstandart order of August 29, 2017 No. 971-st

20

GOST R 57502-2017 - Medical devices. Manufacturing process description.

Rosstandart order of June 08, 2017 No. 514-st

21

GOST R 57501-2017 - Maintenance of medical devices. Requirements for governmental purchases.

Rosstandart order of June 08, 2017 No. 513-st

22

GOST R ISO 7886-2-2017 - injection single use syringes, sterile. Part 2. Syringes for use with automatic syringe infusion pumps.

Rosstandart order of August 29, 2017 No. 972-st

23

GOST __-2017 - Telemedicine systems. General requirements for the basic safety and essential performance of mobile telemedicine laboratory diagnostic systems.

24

GOST __-2017 - Telemedicine systems. General requirements for the basic safety and essential performance ofstationary telemedical consultative-diagnostic centres.

25

GOST R 57386-2017 - Implants for surgery. Fundamental principles

Rosstandart order of February 22, 2017 No. 53-st

26

GOST R 57387-2017 - Implants for surgery. Standard test method for measuring load induced subsidence of intervertebral deviceы under static axial compression.

Rosstandart order of February 22, 2017 No. 54-st

27

GOST R 57388-2017 - Implants for surgery. Standard specification and test methods for absorbable plates and screws for internal fixation implants.

Rosstandart order of February 22, 2017 No. 55-st

28

GOST R 57389-2017 - Implants for surgery. Standard specification and test methods for metallic bone staples.

Rosstandart order of February 22, 2017 No. 56-st

29

GOST R 57390-2017 - Implantaty for surgery. Standard test methods for spinal implant constructs in a model of vertebrectomy.

Rosstandart order of February 22, 2017 No. 57-st

30

GOST R ISO 12189-2017 - Implants for surgery. Mechanical testing of implantable spinal devices. Fatigue test method for spinal implant assemblies using an anterior support.

Rosstandart order of February 22, 2017 No. 58-st

31

GOST R ISO 13179-1-2017 - Implants for surgery. Plasma sprayed unalloyed titanium coatings on metallic surgical implants. Part 1. General requirements.

Rosstandart order of February 22, 2017 No. 59-st

32

GOST R ISO 13782-2017 - Implants for surgery. Metallic materials. Unalloyed tantalum for surgical implants.

Rosstandart order of February 22, 2017 No. 60-st

33

GOST R ISO 14630-2017 - Non-active surgical implants. General requirements.

Rosstandart order of February 22, 2017 No. 61-st

34

GOST R ISO 15142-1-2017 - Implants for surgery. Metal intramedullary nailing systems. Part 1. Intramedullary nails.

Rosstandart order of February 22, 2017 No. 62-st

35

GOST R ISO 15142-2-2017 - Implants for surgery. Metal intramedullary nailing systems. Part 2. Locking components.

Rosstandart order of February 22, 2017 No. 63-st

36

GOST R ISO 14607-2017 - Non-active surgical Implants. Breast implants. Particular requirements.

Rosstandart order of February 22, 2017 No. 64-st

37

GOST R ISO 16402-2017 - Implants for surgery. Cement based on acrylic resin. Fatigue testing in bending of cement based on acrylic resin used in orthopedics.

Rosstandart order of February 22, 2017 No. 65-st


TO THE BEGINNING


Your question to the medical industry professionals:

* * *
CAPTCHA
* Personal data processing consent:*