AAMI Products

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 are ANSI/AAMI/ISO 8637-3 on plasmafilters and ANSI/AAMI/IEC 60601-2-39:2018 on peritoneal dialysis equipment. Also new to the collection are AAMI TIR72 on dialysis fluid chemical composition and AAMI TIR77 on sorbent-based regenerative hemodialysis systems. ANSI/AAMI/RD47 on reprocessing of hemodialyzers has been updated.

• 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 TIR58:2014
• AAMI TIR43:2011
• AAMI TIR77:2018
• ANSI/AAMI RD47:2020, formerly ANSI/AAMI RD47:2008/(R)2013

Date of Publication: September 2020

Pages: 591

ISBN: 978-1-57020-772-3