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  • AAMI
    AAMI Biological Package
    Edition: VAR
    $3,087.00
    / user per year

Content Description

AAMI Biological Package package includes:
  • ANSI/AAMI/ISO 10993-2-2006/(R)2014 - Biological evaluation of medical devices-Part 2: Animal welfare requirements / 2006
  • ANSI/AAMI/ISO 10993-3:2014 - Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity / 2014
  • ANSI/AAMI/ISO 10993-4:2017, Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood / 2017
  • ANSI/AAMI/ISO 10993-5:2009/(R)2014 - Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity / 2009
  • ANSI/AAMI/ISO 10993-6:2016 - Biological evaluation of medical devices-Part 6: Tests for local effects after implantation / 2016
  • ANSI/AAMI/ISO 10993-9:2009/(R)2014 - Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products / 2009
  • ANSI/AAMI/ISO 10993-10:2010/(R)2014 - Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization / 2010
  • ANSI/AAMI/ISO 10993-11:2017, Biological evaluation of medical devices-Part 11: Tests for systemic toxicity / 2017
  • ANSI/AAMI/ISO 10993-12:2012 - Biological evaluation of medical devices-Part 12: Sample preparation and reference materials / 2012
  • ANSI/AAMI/ISO 10993-13-2010/(R)2014 - Biological evaluation of medical devices-Part 13: Identification and quantification of degradation products from polymeric devices / 2014
  • ANSI/AAMI/ISO 10993-14:2001/(R)2011 - Biological evaluation of medical devices-Part 14: Identification and quantification of degradation products from ceramics / 2001
  • ANSI/AAMI/ISO 10993-15:2019 Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys / 2019
  • ANSI/AAMI/ISO 10993-16:2017 / 2017
  • ANSI/AAMI/ISO 10993-17:2002/(R)2012 - Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances / 2002
  • ANSI/AAMI/ISO 13022:2012 - Medical products containing viable human cells-Application of risk management and requirements for processing practices / 2012
  • ANSI/AAMI/ISO 14155:2011 - Clinical investigation of medical devices for human subjects. / 2011
  • ANSI/AAMI/ISO 22442-2:2016 - Medical devices utilizing animal tissues and their derivatives-Part 2: Controls on sourcing, collection and handling. / 2016
  • ANSI/AAMI/ISO 22442-3:2007/(R)2016 - Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents / 2007
  • ANSI/AAMI BE83:2006/(R)2011 - Biological evaluation of medical devices-Part 18: Chemical characterization of materials / 2006
  • ANSI/AAMI/ISO TIR10993-19:2006 - Biological evaluation of medical devices-Part 19: Physio-chemical, morphological and topographical characterization of materials / 2006
  • ANSI/AAMI/ISO TIR10993-20:2006 - Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices / 2006
  • AAMI/ISO TIR22442-4:2011/(R)2016 - 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 / 2011
  • ANSI/AAMI/ISO TIR37137:2014 - Cardiovascular biological evaluation of medical devices-Guidance for absorbable implants / 2014

About AAMI

The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 8,000 professionals united by one important mission—the development, management, and use of safe and effective health technology.
 
AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals. AAMI helps members:
 
Contain costs
Stay on top of new technology and policy developments
Add value in healthcare organizations
Improve professional skills
Enhance patient care
AAMI provides a unique and critical forum for a variety of professionals including clinical and biomedical engineers and technicians, physicians, nurses, hospital administrators, educators, scientists, manufacturers, distributors, government regulators, and others with an interest in healthcare technology. AAMI fulfills its mission through:
 
Courses, conferences, and continuing education, including certification programs.
Collaborative initiatives, including summits with the FDA
A rich array of resources, including peer-reviewed journals, technical documents, books, videos, podcasts, and other products.
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