Biological evaluation of medical devices - Part 9: framework for identification and quantification of potential degradation products
Edition 2021-09-29

Biological evaluation of medical devices - Part 10: tests for skin sensitization
Edition 2023-02-08

Biological evaluation of medical devices - Part 12: sample preparation and reference materials
Edition 2021-06-16

Biological evaluation of medical devices - Part 13: identification and quantification of degradation products from polymeric medical devices
Edition 2010-09-01

Biological evaluation of medical devices - Part 14: identification and quantification of degradation products from ceramics
Edition 2009-08-01

Biological evaluation of medical devices - Part 15: identification and quantification of degradation products from metals and alloys
Edition 2023-05-24

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Edition 2017-12-06

Biological evaluation of medical devices - Part 17: toxicological risk assessment of medical device constituents
Edition 2023-11-22

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 2023-07-26

Biological evaluation of medical devices - Part 19: physico-chemical, morphological and topographical characterization of materials
Edition 2022-06-15