Standards GOST - Russian national standards - Page 123

Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process

Standard published on 1.3.2022

Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests

Standard published on 1.6.2024

Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity

Standard published on 1.3.2022

Medical devices. Biological evaluation of medical devices. Part 12. Selection and preparation of samples for research

Standard published on 1.6.2024

Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

Standard published on 1.10.2017

Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics

Standard published on 1.1.2013

Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys

Standard published on 1.6.2024

Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

Standard published on 1.3.2022

Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process

Standard published on 1.7.2023

Medical devices. Biological evaluation of medical devices. Part 19. Physico-chemical, morphological and topographical characterization of materials

Standard published on 12.7.2025