IEC TR 62653
Guideline for safe operation of medical equipment used for haemodialysis treatments
|Publication Date:||1 April 2020|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
|ICS Code (Syringes, needles and catheters):||11.040.25|
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.
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.