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ANSI/AAMI/ISO 11137-1:2006/(R)2015 and A1:2013

Sterilization of health care products-Radiation-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, 2ed and Amendment 1.
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ANSI/AAMI/ISO 11138-1:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 1: General requirements
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ANSI/AAMI/ISO 11138-2:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
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ANSI/AAMI/ISO 11138-3:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
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ANSI/AAMI/ISO 11138-4:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
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ANSI/AAMI/ISO 11138-5:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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ANSI/AAMI/ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements.
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ANSI/AAMI/ISO 11140-4:2007/(R)2015

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration.
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ANSI/AAMI/ISO 11140-5:2007/(R)2015

Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs.
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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 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 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 13408-3:2006/(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 13408-6:2005/A1:2013

Aseptic processing of health care products -- Part 6: Isolator systems, 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 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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