|
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 |
|
№ |
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 |
|
№ |
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 |
+7 (499) 653-79-14