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ANSI/AAMI NS28:1988/(R)2015 (PDF)

Intracranial pressure monitoring devices
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ANSI/AAMI NS4:2013/(R)2017 (PDF)

Transcutaneous electrical nerve stimulators
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ANSI/AAMI PB70:2012

ANSI/AAMI PB70 provides manufacturers with a consistent basis for creating device labeling claims regarding barrier efficacy against liquid-borne microorganisms. Through labeling requirements, the standard is also intended to assist end-users in selecting the appropriate protective apparel and drapes to inhibit the transfer of microorganisms associated with blood, body fluids, and other potentially infectious materials.
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ANSI/AAMI PB70:2012 Red-Line (PDF)

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ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 (PDF)

(Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
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ANSI/AAMI ST24:1999/(R)2018 (PDF)

Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
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ANSI/AAMI ST50:2004/(R)2018 (PDF)

Dry heat (heated air) sterilizers
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ANSI/AAMI ST55:2016 (PDF)

Table-top Steam Sterilizers
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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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ANSI/AAMI ST77:2013/(R)2018 (PDF)

Containment devices for reusable medical device sterilization
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ANSI/AAMI/IEC 60601-1-12:2016 (PDF)

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
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ANSI/AAMI/IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
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ANSI/AAMI/IEC 60601-2-16:2012

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.
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ANSI/AAMI/IEC 60601-2-16:2012 Red-Line (PDF)

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ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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ANSI/AAMI/IEC 60601-2-2:2017 (PDF)

Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
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ANSI/AAMI/IEC 60601-2-20:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
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ANSI/AAMI/IEC 60601-2-21:2009/(R)2014 & A1:2016

Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
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ANSI/AAMI/IEC 60601-2-25:2011/(R)2016

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
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