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

Biological evaluation of medical devices—Part 2: Animal welfare requirements
Execute Date: february 2027

Standard published on 28.1.2026

Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices

Standard published on 10.12.2015

Biological evaluation of medical devices—Part 22:Guidance on nanomaterials

Standard published on 30.12.2022

Biological evaluation of medical devices—Part 23:Tests for irritation

Standard published on 27.11.2023