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

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

Norma vydána dne 1.1.2013

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

Norma vydána dne 1.3.2021

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

Norma vydána dne 1.6.2024

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

Norma vydána dne 1.6.2019

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

Norma vydána dne 1.6.2019

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

Norma vydána dne 1.3.2021

Medical devices. Biological evaluation of medical devices. Part 5. Cytotoxicity studies by in vitro methods

Norma vydána dne 1.6.2024

Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation

Norma vydána dne 1.3.2022