What is PD IEC TR 62653 about?
PD IEC TR 62653 discusses guidelines for the safe operation of medical equipment used for hemodialysis treatments. PD IEC TR 62653 layouts the technical recommendations for use of medical equipment in chronic hemodialysis, hemofiltration, and haemodiafiltration. these principles are important to be complied with to ensure safe, permissible, and appropriate application.
The term hemodialysis is used in PD IEC TR 62653 as a synonym for all therapy modalities. 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-biologic...