Biological Evaluation of Medical Devices Series
MEDICAL DEVICE PRODUCT DEVELOPMENT AND TESTING JUST GOT EASIER. AND MORE ECONOMICAL.
Updated to include 10993-9:2009 and 10993-16:2010, this CD brings together all the American National Standards that manufacturers, researchers, laboratories, and regulators involved in development, testing, or approval should not be without, you can't get the ANSI/AAMI/ISO 10993 series of standards for less anywhere!
Fully searchable, this easy-to-use CD includes all current 10993, 14155, and 22442 standards and guidance documents. These documents are widely accepted in the U.S., Europe, and other markets that rely on international standards.
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WHAT'S INCLUDED
With AAMI Standards on CD-Biological Evaluation of Medical Devices Series, you'll get every current published AAMI/American National Standard on this topic for less than $14 per document!
- 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 10993-7:1995/(R)2001)
- 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)2006)
- Part 15: Identification and quantification of degradation products from metals and alloys, 1ed (ANSI/AAMI/ISO 10993-15:2000/(R)2006)
- 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)
- 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 - Part 1: General requirements, 2ed (ANSI/AAMI/ISO 14155-1:2003 (R)2008)
- Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans, 1ed (ANSI/AAMI/ISO 14155-2:2003(R)2008)
- 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, Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- 22442-2:2007, Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- 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