Biological evaluation of medical devices—Part 10:Tests for skin sensitization

Standard published on 23.8.2024

Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Standard published on 26.11.2021

Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Standard published on 27.11.2023

Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Standard published on 29.12.2017

Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics

Standard published on 5.3.2003

Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys

Standard published on 30.12.2022

Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables

Standard published on 26.11.2021

Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents

Standard published on 29.8.2025

Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process

Standard published on 30.12.2022

Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials

Standard published on 30.12.2022