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:Establishment of allowable limits for leachable substances

Standard published on 4.11.2005

Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
Execute Date: september 2026

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

Biological evaluation of medical devices - Part 2: Animal welfare requirements

Standard published on 30.12.2011