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AAMI HIT1000-3(PS):2019

Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
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AAMI/ISO TIR13004:2013/(R)2016

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
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ANSI/AAMI 2700-1:2019

Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
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ANSI/AAMI EQ93:2019

Medical equipment management—Vocabulary used in medical equipment programs
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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 ST72:2019

Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
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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 60601-2-21:2009/(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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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 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 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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