Biological Evaluation of Medical Devices Series
Your source for medical device product development and testing guidance
Updated to include 22442-4 and 14155, this CD brings together 25 American National Standards that manufacturers, researchers, laboratories, and regulators involved in development, testing, or approval should not be without!
Fully searchable, this easy-to-use CD includes 14155 and all current 10993 and 22442 standards and guidance documents. Widely accepted in the U.S., Europe, and other markets that rely on international standards, you can't get the ANSI/AAMI/ISO 10993 series of standards for less anywhere!
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| AAMI Standards on CD: Biological Evaluation of Medical Devices Series | BIOTCD |
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What's included:
- Part 1: Evaluation and testing (ANSI/AAMI/ISO 10993-1:2009)
- Part 2: Animal welfare requirements, (ANSI/AAMI/ISO 10993-2:2006)
- Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity, 2ed (ANSI/AAMI/ISO 10993-3:2003)
- Part 4: Selection of tests for interactions with blood (ANSI/AAMI/ISO 10993-4:2002(R)2009 & A1:2006(R)2009)
- Part 5: Tests for in vitro cytotoxicity, 3ed (ANSI/AAMI/ISO 10993-5:2009)
- Part 6: Tests for local effects after implantation, 2ed (ANSI/AAMI/ISO 10993-6:2007)
- Part 7: Ethylene oxide sterilization residuals, 3ed (ANSI/AAMI/ISO 10993-7:2008
- Part 9: Framework for identification and quantification of potential degradation products, 2ed (ANSI/AAMI/ISO 10993-9:2009)
- Part
10: Tests for irritation and delayed type hypersensitivity, 2ed
(ANSI/AAMI BE78:2002(R)2008; adoption of ISO 10993-10:2002 with national deviation) - Part 11: Tests for systemic toxicity (ANSI/AAMI 10993-11:2006)
- Part 12: Sample preparation and reference materials, 3ed (ANSI/AAMI/ISO 10993-12:2007)
- Part 13: Identification and quantification of degradation products from polymeric medical devices, 1ed (ANSI/AAMI/ISO 10993-13:1999/(R)2004)
- Part 14: Identification and quantification of degradation products from ceramics, 1ed (ANSI/AAMI/ISO 10993-14:2001/(R)2011)
- Part 15: Identification and quantification of degradation products from metals and alloys, 1ed (ANSI/AAMI/ISO 10993-15:2000/(R)2011)
- Part 16: Toxicokinetic study design for degradation products and leachables, 2ed (ANSI/AAMI/ISO 10993-16:2010)
- Part 17: Establishment of allowable limits for leachable substances, 1ed (ANSI/AAMI/ISO 10993-17:2002(R)2008
- Part 18:Chemical characterization of materials (ANSI/AAMI BE83:2006/(R)2011)
- Part 19: Physicochemical, morphological, and topographical characterization of materials (ANSI/AAMI/ISO 10993-19:2006)
- Part 20: Principles and methods for immunotoxicology testing of medical devices (ANSI/AAMI/ISO 10993-20:2006)
- Clinical investigation of medical devices for human subjects (ANSI/AAMI/ISO 14155:2011
- Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals, 1ed and Amendment (AAMI TIR19:1998; TIR19/A1:1999)
- 22442-1:2007/(R)2011, Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- 22442-2:2007/(R)2011, Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- 22442-3:2007/(R)2011, 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
- 22442-4:2010, Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes