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

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

Standard published on 1.1.2026

Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

Standard published on 1.1.2013

Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

Standard published on 1.3.2021

Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies

Standard published on 1.6.2024

Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

Standard published on 1.6.2019

Medical devices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

Standard published on 1.6.2019

Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

Standard published on 1.3.2021