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Biological Evaluation of Medical Devices Standards

     

Biological Evaluation of Medical Devices Standards Package

Biological Evaluation of Medical Devices Series, Edition 2007.1. Includes

  • ANSI/AAMI/ISO 10993-1:2009;Biological evaluation of medical devices - Part 1: Evaluation and testing
  • ANSI/AAMI/ISO 10993-2:2006 (R2010);Biological evaluation of medical devices - Part 2: Animal welfare requirements
  • ANSI/AAMI/ISO 10993-3:2003 (R2009);Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ANSI/AAMI/ISO 10993-4:2002 (R2009) & A1/2006 (R2009); Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
  • ANSI/AAMI/ISO 10993-5:2009;Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ANSI/AAMI/ISO 10993-6:2007/(R)2010;Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • ANSI/AAMI/ISO 10993-7:2008 ;Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • ANSI/AAMI/ISO 10993-9:2009;Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • ANSI/AAMI/ISO 10993-10:2010;Biological evaluation of medical devices - Part 10:
  • ANSI/AAMI 10993-11:2006 (r2010);Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ANSI/AAMI/ISO 10993-12:2007;Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • ANSI/AAMI/ISO 10993-13:2010;Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices
  • ANSI/AAMI/ISO 10993-14:2001 (R2006); Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • ANSI/AAMI/ISO 10993-15:2000 (R2006);Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
  • ANSI/AAMI/ISO 10993-16: 2010;Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
  • ANSI/AAMI/ISO 10993-17:2002 (R2008);Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
  • ANSI/AAMI BE83:2006;Biological evaluation of medical devices - Part 18: Chemical characterization of materials
  • ANSI/AAMI/ISO TIR10993-19:2006;Biological evaluation of medical devices - Part 19: Physio-chemical, morphological and topographical characterization of materials
  • ANSI/AAMI/ISO TIR10993-20:2006;Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
  • ANSI/AAMI/ISO 14155-2011;Clinical investigation of medical devices for human subjects - Good Clinical Practice
  • ANSI/AAMI/ISO 22442-1:2007: Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management
  • ANSI/AAMI/ISO 22442-2:2007: Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and Handling
  • ANSI/AAMI/ISO 22442-3:2007: Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
  • AAMI TIR19:1998:Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals.

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