This collection of AAMI dialysis standards and technical information reports includes the latest versions of all dialysis documents. AAMI adopted the 2019 ISO 23500 series of dialysis fluid standards as replacements for the ANSI/AAMI 2014 versions, which have been technically revised. AAMI also adopted the ISO 8637 series standards, which supersede the previous versions that had been published under separate designations. These are American National Standards. A crosswalk of the current and former designations of these standards is presented below and replaces the “Glossary of equivalent standards” sections in the documents that follow.
Added to the AAMI collection for the first time is the Acute Dialysis Survey Readiness Handbook, 2nd Edition. Updated in 2021, this handbook brings together applicable requirements from the U.S. Centers for Medicare & Medicaid Services (CMS), consensus standards, and other requirements from the four major hospital accrediting organizations: The Joint Commission, Healthcare Facilities Accreditation Program, DNV Healthcare, and Center for Improvement in Healthcare Quality.
New editions of AAMI TIR43:2021, Ultrapure dialysis fluid for hemodialysis and related therapies, and TIR58, Water testing methodologies, have also been added to the collection.
Complete Dialysis Collection
- ANSI/AAMI/ISO 23500-1:2019, formerly ANSI/AAMI 23500:2014
- ANSI/AAMI/ISO 23500-2:2019, formerly ANSI/AAMI 26722:2014
- ANSI/AAMI/ISO 23500-3:2019, formerly ANSI/AAMI 13959:2014
- ANSI/AAMI/ISO 23500-4:2019, formerly ANSI/AAMI 13958:2014
- ANSI/AAMI/ISO 23500-5:2019, formerly ANSI/AAMI 11663:2014
- ANSI/AAMI/ISO 8637-1:2017, formerly ANSI/AAMI/ISO 8637:2010 and ISO 8637:2010/AMD1-2013
- ANSI/AAMI/ISO 8637-2:2018, formerly ANSI/AAMI/ISO 8638:2010
- ANSI/AAMI/IEC 8637-3:2018, formerly ISO 13960:2010
- ANSI/AAMI/IEC 60601-2-16:2018, formerly ANSI/AAMI/IEC 60601-2-16:2012
- ANSI/AAMI/IEC 60601-2-39:2018, formerly IEC 60601-2-39:2007
- AAMI TIR72:2017
- AAMI TIR58:2021
- AAMI TIR43:2021
- AAMI TIR77:2018
- ANSI/AAMI RD47:2020, formerly ANSI/AAMI RD47:2008/(R)2013
- Acute Dialysis: Survey Readiness Handbook, 2nd edition, 2021
Date of Publication: May 2021