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ANSI/AAMI ST67:2019

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
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$131.00
$131.00
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ANSI/AAMI ST77:2013/(R)2018 (PDF)

Containment devices for reusable medical device sterilization
$93.00
$162.00
$162.00
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ANSI/AAMI ST79:2017

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
$357.00
$408.00
$408.00
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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.
$160.00
$282.00
$282.00
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ANSI/AAMI/ISO 11135:2014/A1:2018

Sterilization of health-care products— Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release
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ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019

Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
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$243.00
$243.00
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ANSI/AAMI/ISO 11137-2: 2013/(R)2019

Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
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$243.00
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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
$74.00
$131.00
$131.00
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ANSI/AAMI/ISO 11138-1:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 1: General requirements
$137.00
$243.00
$243.00
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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
$65.00
$114.00
$114.00
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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
$65.00
$114.00
$114.00
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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
$65.00
$114.00
$114.00
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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
$65.00
$114.00
$114.00
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ANSI/AAMI/ISO 11138-7:2019

Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
$137.00
$243.00
$243.00
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ANSI/AAMI/ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements.
$93.00
$162.00
$162.00
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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 11737-1:2018 (PDF)

Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
$99.00
$173.00
$173.00
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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 13408-5-2006/(R)2015

Aseptic processing of health care products - Part 5: Sterilization in place
$74.00
$131.00
$131.00
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