IEC TR 62653:2020 ED2

Guideline for safe operation of medical equipment used for haemodialysis treatments

Publication date:   Apr 17, 2020

Scope

IEC TR 62653:2020 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.
The physician is responsible for the treatment prescription. However, the Organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. The requirements of IEC 60601-2-16 ensure that medical electrical equipment used for extracorporeal renal replacement therapy operates with a high level of safety. Despite that high level of safety, however, some residual risk remains, related to medical-biological, physical-chemical and technical Hazards. The Organization administering the treatment is responsible for managing the residual risk. This document is not intended to be used as the basis of regulatory inspection or certification assessment activities. IEC TR 62653:2020 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) update the relevant references to the new numbering scheme of the ISO 23500 family;
b) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 62353:2014 and 60601-2-16:2018;
c) technical additions in several sections.