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

Standard published on 24.5.2023

Tracked Changes. Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys.

Standard published on 26.5.2023

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

Standard published on 30.3.2020

Tracked Changes. Biological evaluation of medical devices. Toxicological risk assessment of medical device constituents.

Standard published on 20.12.2023

Biological evaluation of medical devices. Toxicological risk assessment of medical device constituents.

Standard published on 26.1.2026

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

Standard published on 27.7.2023

Biological evaluation of medical devices. Animal welfare requirements.

Standard published on 10.11.2025

Biological evaluation of medical devices. Tests for irritation.

Standard published on 4.11.2025

Biological evaluation of medical devices. Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity.

Standard published on 8.10.2026

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

Standard published on 30.4.2025