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. Tests for genotoxicity, carcinogenicity and reproductive toxicity.

Standard published on 31.10.2014

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

Standard published on 30.4.2025

Biological evaluation of medical devices. Tests for in vitro cytotoxicity.

Standard published on 17.3.2025

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

Standard published on 20.5.2026

Tracked Changes. Biological evaluation of medical devices. Tests for local effects after implantation.

Standard published on 4.6.2026

Biological evaluation of medical devices. Ethylene oxide sterilization residuals.

Standard published on 9.6.2026