BS PD IEC TR 62653:2020

This document describes the technical recommendations for use of medical equipment in chronic HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles are important to be complied with to ensure safe, permissible and appropriate application.

The term HAEMODIALYSIS is used in this document as synonym for all therapy modalities.

The scope can be applicable to the use of the medical equipment in home, acute and pediatrics environment. The scope may also be applicable to SORBENT DIALYSIS SYSTEMS.Cross References:ISO/IEC TS 27008IEC 80001IEC 60601-1-11:2015IEC 60364-7-710:2002IEC 60601-2-16:2018ISO 14971:2019IEC 62353:2014 ISO 23500-5:2019IEC 60601-1:2005/AMD1:2012ISO 23500-2:2019ISO 23500-3:2019IEC 60601-1:2005ISO 23500-4:2019IEC 60309-2:1999 ISO 23500-1:2019ISO/IEC 27001:2013