Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Edition 2019-11

Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Edition 2021-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Edition 2017-09

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Edition 2021-01

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1
Edition 2024-06

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Edition 2010-06

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
Edition 2001-11

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 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