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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 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 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- 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/ISO 11140-3:2007/(R)2015

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test.
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ANSI/AAMI/ ISO 14117:2019

Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
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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 14708-5: 2010/(R)2015 (PDF)

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/ ISO 81060-2:2019

Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type
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ANSI/AAMI/ ISO 8638:2010/(R)2015

Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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