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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 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
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AAMI EQ93:2018(PS) (PDF)

Medical equipment management--Vocabulary used in medical equipment programs
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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 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 ST72:2011/(R)2016 (PDF)

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
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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/ ISO 11137-1: 2006/(R)2015 & A1:2013 (PDF Version)

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices (Consolidated Text)
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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 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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