International Organization for Standardization (ISO)
Latest
ISO 10993-1:2018
ISO 10993-1:2018 Referenced Document
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 10993-1:2018 history
2018ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
2010ISO 10993-1:2009/Cor 11:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
2010ISO 10993-1:2009/cor 1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Technical Corrigendum 1
2009ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
2003ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
1997ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
1992ISO 10993-1:1992/Cor 1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests; technical corrigendum 1
1992ISO 10993-1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests