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

Norma vydána dne 1.6.2024

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

Norma vydána dne 1.3.2022

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

Norma vydána dne 1.6.2024

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

Norma vydána dne 1.10.2017

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

Norma vydána dne 1.1.2013

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

Norma vydána dne 1.6.2024

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

Norma vydána dne 1.3.2022

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

Norma vydána dne 1.7.2023

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

Norma vydána dne 12.7.2025

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

Norma vydána dne 1.1.2026