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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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AAMI/ISO TIR19218-1:2011 & A1:2013

Medical devices hierarchal coding structure for adverse events. Part 1: Event type codes. (Includes Amendment 1)
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ANSI/AAMI 11663:2014

Quality of dialysis fluid for hemodialysis and related therapies.
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ANSI/AAMI 13958:2014

Concentrates for hemodialysis and related therapies.
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ANSI/AAMI 13959:2014

Water for hemodialysis and related therapies.
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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 Format)

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ANSI/AAMI ST72:2011/(R)2016 (PDF)

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
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ANSI/AAMI ST90:2017

Processing of health care products - Quality management systems for processing in health care facilities
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ANSI/AAMI/ ISO 14708-5: 2010/(R)2015

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
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ANSI/AAMI/ISO 15223-2:2010/(R)2016

Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
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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 60601-2-25:2011/(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

Medical electrical equipment - Part 2-50: Particular requirements for 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 10993-11-2006/(R)2014

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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