Normas ISO

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

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

Biological evaluation of medical devices-- Part 17: Establishment of allowable limits for leachable substances

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1

Biological evaluation of medical devices-- Part 18: Chemical characterization of materials