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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.
$114.00
$200.00
$200.00
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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.
$93.00
$162.00
$162.00

ANSI/AAMI/ISO 11607-1:2019

Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
$93.00
$162.00
$162.00
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ANSI/AAMI/ISO 11607-2:2019

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
$74.00
$131.00
$131.00
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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
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$131.00
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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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$131.00
$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
$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
$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)
$74.00
$131.00
$131.00
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ANSI/AAMI/ISO 13408-6:2005/A1:2013

Aseptic processing of health care products -- Part 6: Isolator systems, Amendment 1.
$40.00
$70.00
$70.00
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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
$93.00
$162.00
$162.00
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ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes
$137.00
$243.00
$243.00
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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
$243.00
$243.00
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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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$243.00
$243.00
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ANSI/AAMI/ISO 14708-3:2017 (PDF)

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$228.00
$228.00
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ANSI/AAMI/ISO 14708-4:2008/(R)2011

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps.
$130.00
$228.00
$228.00
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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
$209.00
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ANSI/AAMI/ISO 15223-1:2016 (PDF)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
$93.00
$162.00
$162.00
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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
$65.00
$114.00
$114.00
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