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

Norma vydaná dňa 1.6.2024

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

Norma vydaná dňa 1.3.2022

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

Norma vydaná dňa 1.6.2024

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

Norma vydaná dňa 1.10.2017

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

Norma vydaná dňa 1.1.2013

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

Norma vydaná dňa 1.6.2024

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

Norma vydaná dňa 1.3.2022

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

Norma vydaná dňa 1.7.2023

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

Norma vydaná dňa 12.7.2025

Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements

Norma vydaná dňa 1.1.2026