MDD Biologic Safety
EN ISO 10993-14
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
EN ISO 10993-15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
EN ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
EN ISO 10993-17
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
EN ISO 10993-18
Biological evaluation of medical devices - Part 18: Chemical characterization of materials