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ANSI/AAMI/ISO 11737-2:2019

Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
$93.00
$162.00
$162.00
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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).
$137.00
$243.00
$243.00

ANSI/AAMI/ISO 13408-2:2018 (PDF)

Aseptic processing of health care products—Part 2: Sterilizing filtration
$74.00
$131.00
$131.00
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ANSI/AAMI/ISO 13408-3:2006/(R)2015

Aseptic processing of health care products - Part 3: Lyophilization.
$74.00
$131.00
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ANSI/AAMI/ISO 13408-4-2005/(R)2014

Aseptic processing of health care products - Part 4: Clean-in-place technologies
$74.00
$131.00
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ANSI/AAMI/ISO 13408-5-2006/(R)2015

Aseptic processing of health care products - Part 5: Sterilization in place
$74.00
$131.00
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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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$131.00
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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
$137.00
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$243.00
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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.
$118.00
$209.00
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ANSI/AAMI/ISO 14971:2019 (PDF)

Medical devices—Application of risk management to medical devices
$137.00
$243.00
$243.00
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ANSI/AAMI/ISO 15223-2:2010/(R)2016

Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
$74.00
$131.00
$131.00

ANSI/AAMI/ISO 15882:2008/(R)2013

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results.
$114.00
$200.00
$200.00
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ANSI/AAMI/ISO 17664:2017 (PDF)

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.

Supersedes ST81
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$200.00
$200.00
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ANSI/AAMI/ISO 17665-1:2006/(R) 2013

Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices.
$130.00
$228.00
$228.00
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ANSI/AAMI/ISO 20857:2010/(R)2015

Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices.
$137.00
$243.00
$243.00

ANSI/AAMI/ISO 22442-1:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management.
$99.00
$173.00
$173.00
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ANSI/AAMI/ISO 23500-2:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies
$130.00
$228.00
$228.00
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ANSI/AAMI/ISO 23500-3:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
$93.00
$162.00
$162.00
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ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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