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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 10993-5:2009/(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 11607-1:2006/(R)2015 (PDF)

Packaging for terminally sterilized medical devices • Part 1: Requirements for materials, sterile barrier systems, and packaging systems
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ANSI/AAMI/ISO 11607-2:2006/(R)2015

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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ANSI/AAMI/ISO 11737-2-2009/(R)2014

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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ANSI/AAMI/ISO 12417-1:2015 (PDF)

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
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ANSI/AAMI/ISO 13022:2012

Medical products containing viable human cells -- Application of risk management and requirements for processing practices.
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ANSI/AAMI/ISO 13408-7:2012/(R)2018 (PDF)

Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products
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ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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ANSI/AAMI/ISO 14117:2012

Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.
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ANSI/AAMI/ISO 14155:2011

Clinical investigation of medical devices for human subjects.
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ANSI/AAMI/ISO 14160:2011/(R)2016 (PDF)

Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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ANSI/AAMI/ISO 14708-1:2014

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
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