Standards developed by MEDITEX company


Data on approval of national standards developed by MEDITEX company at our own expense

 

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

Data on approval of national standards/introduction of interstate standards in fulfillment of the State contract № 130-107 of May 12, 2015   

 

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

IMBIIT 

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

Data on approval of national standards/introduction of interstate standards in fulfillment oа the State contract № 130-10 of March 14, 2016   

 

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.

 

 

CYTOproect

   

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


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