No products
AAMI/ISO 11137-1 AMD 1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
AAMI/ISO 10993-9:1999 (R2014) Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
AAMI/ISO 10993-7:2008 (R2012) Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
AAMI/ISO 10993-5:2009 (R2014) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
AAMI/ISO 10993-4:2002 (R2013) Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
AAMI/ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
AAMI/ISO 10993-2:2006 (R2014) Biological evaluation of medical devices - Part 2: Animal welfare requirements
AAMI/ISO 10993-1:2009 (R2013) Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
AAMI/ISO 10993-17:2002 (R2012) Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
AAMI/ISO 10993-15:2000 (R2011) Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
AAMI/ISO 10993-14:2001 (R2011) Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
AAMI/ISO 10993-13:2010 (R2014) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices