Catalog of standards
Catalog of standards
11
HEALTH CARE TECHNOLOGY
11.040
Medical equipment
11.040.40
Implants for surgery, prosthetics and orthotics
| Reference number of the normative document | Title of the normative document | Կարգավիճակը | Developer of the normative document and its address | Price in Armenian drams (AMD) (including VAT) |
Cart |
| GOST ISO 8615-2012 | Implants for surgery. Fixation devices for use in the ends of the femur in adults. Technical requirements | Active |
|
7200 |
Russian |
| AST GOST R ISO 11318-2016 | Connector assembly DF-1 for implantable defibrillators. Technical requirements and test methods | Active |
|
6400 |
Russian |
| GOST ISO 14602-2012 | Non-active surgical implants. Implants for osteosynthesis. Particular requirements | Active |
|
5200 |
Russian |
| AST GOST R ISO 14630-2023 | Non-active surgical implants. General requirements | Active |
|
5600 |
Russian |
| AST GOST R ISO 15032-2023 | Prostheses. Structural testing of hip units | Active |
|
11200 |
Russian |
| AST GOST R ISO 16061-2023 | Instrumentation for use in association with non-active surgical implants. General requirements | Active |
|
5600 |
Russian |
| AST GOST R ISO 21534-2023 | Non-active surgical implants. Joint replacement implants. Particular requirements | Active |
|
4400 |
Russian |
| AST GOST R ISO 21535-2023 | Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants | Active |
|
3600 |
Russian |
| AST GOST R ISO 21536-2023 | Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants | Active |
|
2800 |
Russian |
| AST GOST R ISO 25539-1-2023 | Cardiovascular implants. Endovascular devices. Part 1. Endovascular prostheses | Active |
|
26000 |
Russian |
| AST GOST R ISO 25539-2-2023 | Cardiovascular implants. Endovascular devices. Part 2. Vascular stents | Active |
|
29600 |
Russian |
| GOST 30399-95 | Implants for surgery. Metal bone screws with asymmetrical thread and spherical under-surface. Mechanical requirements and test methods | Active |
- - |
1600 |
Russian |
| GOST 30400-95 | Implants for surgery. Metal bone screws with hexagonal drive connection, spherical under surface of head, asymmetrical thread. Dimensions | Active |
- - |
3600 |
Russian |
| GOST 31212-2003 | Implantable cardiac pacemakers. General specifications and basic test methods | Active |
|
4800 |
Russian |
