Catalog of standards
Catalog of standards | Reference number of the normative document | Title of the normative document | Status | Developer of the normative document and its address | Price in Armenian drams (AMD) (including VAT) |
Cart |
| AST GOST R ISO 22442-1-2023 | Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management | Active |
|
8800 |
Russian |
| GOST ISO/TS 10993-19-2024 | Medical devices. Biological evaluation of medical devices. Part 19. Physico-chemical, morphological and topographical characterization of materials | Active |
|
5600 |
Russian |
| GOST ISO 10993-1-2021 | Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process | Active |
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| GOST ISO 10993-5-2023 | Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity | Active |
|
10000 |
Russian |
| GOSt ISO 10993-6-2021 | Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation | Active |
|
10800 |
Russian |
| GOST ISO 10993-9-2022 | Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products | Active |
|
3600 |
Russian |
| GOST ISO 10993-10-2023 | Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests | Active |
|
17200 |
Russian |
| AST ISO 10993-11-2015 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Active |
National Institute of Standards CJSV (Yerevan) 2004 c. Yrevan, Komitas str. 49/4 |
14400 |
Armenian |
| GOST ISO 10993-12-2023 | Medical devices. Biological evaluation of medical devices. Part 12. Selection and preparation of samples for research | Active |
|
8000 |
Russian |
| GOST ISO 10993-14-2011 | Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics | Active |
|
6800 |
Russian |
| GOST ISO 10993-15-2023 | Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys | Active |
|
5600 |
Russian |
| GOST ISO 10993-16-2021 | Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables | Active |
|
4400 |
Russian |
| GOST ISO 10993-17-2011 | Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances | Active |
|
13600 |
Russian |
| GOST ISO 10993-18-2022 | Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process | Active |
|
24800 |
Russian |
| AST ISO 10993-20-2015 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices | Active |
|
22000 |
Armenian |
| GOST ISO 10993-23-2023 | Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies | Active |
|
20000 |
Russian |
| AST GOST R ISO 14155-2023 | Clinical investigation of medical devices for human subjects. Good clinical practice | Active |
|
29200 |
Russian |
| AST ISO/TS 16782-2020 | Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing | Active |
NATIONAL BODY FOR STANDARDS AND METROLOGY |
32500 |
Armenian |
| AST GOST R ISO 20776-1-2023 | Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Part 1. Broth microdilution reference method for laboratory testing of the activity of antimicrobial agents against rapidly growing infectious disease-causing aerobic bacteria | Active |
|
7600 |
Russian |
| AST GOST R ISO 22442-2-2023 | Medical devices utilizing animal tissues and their derivatives. Part 2. Controls on sourcing, collection and handling | Active |
|
5200 |
Russian |
| AST GOST R ISO 22442-3-2023 | Medical devices utilizing animal tissues and their derivatives. Part 3. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy agents | Active |
|
7200 |
Russian |
| GOST 34901-2022 | Medical devices. Biological impact evaluation system. General requirements for research (testing) | Active |
|
8800 |
Russian |
