The Complete ISO 10993 Biological Evaluation of Medical Devices List

Standard:Title:
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO-10993-4 Amendment 1 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO-10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-9 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-13 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-15 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-16 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-17 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-19 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-20 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices