ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Standard No.

ISO 10993-1:2018

Release Date

2018

Published By

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

• 2018 ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• 2010 ISO 10993-1:2009/Cor 11:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
• 2010 ISO 10993-1:2009/cor 1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Technical Corrigendum 1
• 2009 ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• 2003 ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
• 1997 ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
• 1992 ISO 10993-1:1992/Cor 1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests; technical corrigendum 1
• 1992 ISO 10993-1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests