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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 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 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 11137-1:2006/A1:2013

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, Amendment 1.
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ANSI/AAMI/ISO 11137-2:2013

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose.
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ANSI/AAMI/ISO 11137-3-2017 (PDF)

Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control
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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 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 13408-1:2008/(R)2011/A1:2013

Aseptic processing of health care products -- Part 1: General requirements, Amendment 1.
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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 13408-6:2005/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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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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