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

Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Standard published on 4.6.2019

Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

Standard published on 15.4.2022

Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity

Standard published on 29.12.2017

Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Standard published on 15.4.2022

Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Standard published on 10.12.2015

Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

Standard published on 30.12.2022