Biological evaluation of medical devices. Tests for skin sensitization.

Standard published on 8.2.2023

Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization.

Standard published on 17.2.2023

Biological evaluation of medical devices. Tests for systemic toxicity.

Standard published on 10.11.2025

Biological evaluation of medical devices. Sample preparation and reference materials.

Standard published on 4.11.2025

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

Standard published on 31.10.2010

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

Standard published on 30.6.2009

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