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AAMI TIR43:2011

Ultrapure dialysate for hemodialysis and related therapies
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AAMI TIR58:2014

Water testing methodologies
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AAMI TIR72:2017 (PDF)

Dialysis fluid chemical composition
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AAMI TIR77:2018 (PDF)

Sorbent-based regenerative hemodialysis systems
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ANSI/AAMI RD47:2020

Reprocessing of hemodialyzers
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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/ISO 23500-1:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements
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ANSI/AAMI/ISO 23500-2:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies
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ANSI/AAMI/ISO 23500-3:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies
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ANSI/AAMI/ISO 23500-4:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies
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ANSI/AAMI/ISO 23500-5:2019

Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies
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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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ANSI/AAMI/ISO 8638:2010/(R)2015 (PDF)

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