Harmonized Standards
EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
EN ISO 10993-03
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
EN ISO 10993-04
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
EN ISO 10993-05
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
EN ISO 10993-06
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-07
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
EN ISO 10993-09
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
EN ISO 10993-11
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
EN ISO 10993-13
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices