TheraGenesis

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process more

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood more

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity more

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation more

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals more

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

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity more

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials more

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

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

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

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