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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 60601-2-4:2010/A1:2018 (Consolidated Text)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
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$282.00
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ANSI/AAMI/IEC 60601-2-50:2009/(R)2014 & A1:2016

Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
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ANSI/AAMI/IEC 80601-2-30:2018

Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
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ANSI/AAMI/IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
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$162.00
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ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 (PDF)

Amendment 1 to Medical Electrical Equipment Part 2-58
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ANSI/AAMI/ISO 10993-11:2017

Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
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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 10993-13-2010/(R)2014

Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices.
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ANSI/AAMI/ISO 10993-15:2000/(R)2011

Biological evaluation of medical devices, Part 15: Identification and quantification of degradation products from metals and alloys.
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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 10993-4:2017

Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
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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 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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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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$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
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$114.00
$114.00
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