Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Edition 2019-11

Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables
Edition 2025-12

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Edition 2017-05

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
Edition 2023-09

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1
Edition 2025-11

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
Edition 2020-01

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor
Edition 2022-05

Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Edition 2020-03

Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
Edition 2006-08