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ANSI/AAMI/IEC 60601-2-27:2011/(R)2016

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
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ANSI/AAMI/IEC 60601-2-47:2012/(R)2016

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
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ANSI/AAMI/IEC 62366-1:2015 (PDF)

Medical Devices Part 1: Application of Usability Engineering to Medical Devices
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ANSI/AAMI/ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
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ANSI/AAMI/ISO 10993-14:2001/(R)2011

Biological evaluation of medical devices, Part 14: Identification and quantification of degradation products from ceramics.
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ANSI/AAMI/ISO 10993-17:2002/(R)2012

Biological evaluation of medical devices, Part 17: Establishment of allowable limits for leachable substances.
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ANSI/AAMI/ISO 10993-2-2006/(R)2014

Biological evaluation of medical devices - Part 2: Animal welfare requirements
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ANSI/AAMI/ISO 10993-3:2014

Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
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ANSI/AAMI/ISO 10993-6:2016 (PDF)

Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
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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 & 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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ANSI/AAMI/ISO 11138-1:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 1: General requirements
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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
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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
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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
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ANSI/AAMI/ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements.
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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.
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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.
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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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