Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
ANSI/AAMI/ISO 11138-2:2017/(R)2024

ANSI/AAMI/ISO 11138-2:2017/(R)2024

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Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes

€126.00

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ANSI/AAMI/ISO 11138-3:2017/(R)2024

ANSI/AAMI/ISO 11138-3:2017/(R)2024

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Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes

€126.00

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ANSI/AAMI/ISO 11138-4:2017/(R)2024

ANSI/AAMI/ISO 11138-4:2017/(R)2024

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Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes

€126.00

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ANSI/AAMI/ISO 11138-5:2017/(R)2024

ANSI/AAMI/ISO 11138-5:2017/(R)2024

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Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

€126.00

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ANSI/AAMI/ISO 11138-7:2019

ANSI/AAMI/ISO 11138-7:2019

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Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results

€268.00

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ANSI/AAMI/ISO 13408-7:2012/(R)2018

ANSI/AAMI/ISO 13408-7:2012/(R)2018

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Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products

€178.00

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ANSI/AAMI/ISO 11607-1:2019

ANSI/AAMI/ISO 11607-1:2019

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Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

€251.00

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ANSI/AAMI/ISO 14160:2011/(R)2016

ANSI/AAMI/ISO 14160:2011/(R)2016

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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 proces

€268.00

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ANSI/AAMI/ISO 11607-2:2019

ANSI/AAMI/ISO 11607-2:2019

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Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

€174.00

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ANSI/AAMI/ISO 14937:2009/(R)2013

ANSI/AAMI/ISO 14937:2009/(R)2013

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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

€268.00

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ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017 [HISTORICAL]

ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017 [HISTORICAL]

Withdrawn Most Recent

Aseptic processing of health care products—Part 1: General requirements (includes Amendment 1)

€268.00

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ANSI/AAMI/ISO 13408-2:2018

ANSI/AAMI/ISO 13408-2:2018

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Aseptic processing of health care products—Part 2: Sterilizing filtration

€204.00

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ANSI/AAMI/ISO 13408-3:2006/(R)2015

ANSI/AAMI/ISO 13408-3:2006/(R)2015

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Aseptic processing of health care products—Part 3: Lyophilization

€144.00

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ANSI/AAMI/ISO 13408-4:2005/(R)2014

ANSI/AAMI/ISO 13408-4:2005/(R)2014

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Aseptic processing of health care products—Part 4: Clean-in-place technologies

€144.00

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ANSI/AAMI/ISO 13408-5:2006/(R)2015

ANSI/AAMI/ISO 13408-5:2006/(R)2015

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Aseptic processing of health care products—Part 5: Sterilization in place

€144.00

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