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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 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 13408-1:2008/(R)2017 & A1:2013

Aseptic processing of health care products -- Part 1: General requirements (includes Amendment 1).
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ANSI/AAMI/ISO 13408-2:2018 (PDF)

Aseptic processing of health care products—Part 2: Sterilizing filtration
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ANSI/AAMI/ISO 13408-3:2006/(R)2015

Aseptic processing of health care products - Part 3: Lyophilization.
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ANSI/AAMI/ISO 13408-4-2005/(R)2014

Aseptic processing of health care products - Part 4: Clean-in-place technologies
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ANSI/AAMI/ISO 13408-5-2006/(R)2015

Aseptic processing of health care products - Part 5: Sterilization in place
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ANSI/AAMI/ISO 13408-6:2005/(R)2013

Aseptic processing of health care products -- Part 6: Isolator systems. (Includes Amendment 1)
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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 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 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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ANSI/AAMI/ISO 14708-3:2017 (PDF)

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ANSI/AAMI/ISO 14708-4:2008/(R)2011

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps.
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ANSI/AAMI/ISO 14937:2009/(R) 2013

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
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ANSI/AAMI/ISO 14971:2019-PDF

Medical devices—Application of risk management to medical devices
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ANSI/AAMI/ISO 15674:2016 (PDF)

Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
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