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ANSI/AAMI/ISO 10993-10:2010/(R)2014

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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ANSI/AAMI/ISO 10993-11:2017

Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
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ANSI/AAMI/ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
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ANSI/AAMI/ISO 10993-13-2010/(R)2014

Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices.
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ANSI/AAMI/ISO 10993-15:2000/(R)2011

Biological evaluation of medical devices, Part 15: Identification and quantification of degradation products from metals and alloys.
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ANSI/AAMI/ISO 10993-17:2002/(R)2012

Biological evaluation of medical devices, Part 17: Establishment of allowable limits for leachable substances.
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ANSI/AAMI/ISO 10993-2-2006/(R)2014

Biological evaluation of medical devices - Part 2: Animal welfare requirements
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ANSI/AAMI/ISO 10993-3:2014

Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
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ANSI/AAMI/ISO 10993-4:2017

Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
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ANSI/AAMI/ISO 10993-5:2009/(R)2014

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
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ANSI/AAMI/ISO 10993-6:2016 (PDF)

Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
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ANSI/AAMI/ISO 10993-7:2008/(R)2012

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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ANSI/AAMI/ISO 10993-9:2009/(R)2014

Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products.
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ANSI/AAMI/ISO 11135:2014

Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
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ANSI/AAMI/ISO 11135:2014/A1:2018

Sterilization of health-care products— Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release
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ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019

Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
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ANSI/AAMI/ISO 11607-1:2019

Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
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ANSI/AAMI/ISO 11607-2:2019

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
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ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems.
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ANSI/AAMI/ISO 11737-1:2018 (PDF)

Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
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