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-biological, physical-chemical, and technical hazards. the organization administering the treatment is responsible for managing the residual risk.
Note: PD IEC TR 62653 is not intended to be used as the basis of regulatory inspection or certification assessment activities.
Who is PD IEC TR 62653 for?
PD IEC TR 62653 on the safe operation of medical equipment used for hemodialysis treatments is useful for:
- Manufacturers of medical equipment for hemodialysis treatments
- Test laboratories for medical equipment
- Regulatory authorities
- Notified organizations
Why should you use PD IEC TR 62653?
Haemodialysis is a therapeutic method for treating renal insufficiency, in addition, to peritoneal dialysis and renal transplantation. haemodialysis is often used as a general term for related extracorporeal methods of renal replacement therapy. At present, haemodialysis is a standard procedure in renal replacement therapy, which, when applied properly, yields high-quality results. The treatment is a complex procedure that is under the influence of medical-biological, physical-chemical, and technical processes.
PD IEC TR 62653 guideline helps you with treatment, dialysis machine, preparing the vascular access, connection to the extracorporeal circuit, initiation of treatment, hazards during the treatment terminating the dialysis treatment, notification of incidents, handling medical electrical equipment and medical devices for hemodialysis treatments
What’s changed since the last update?
PD IEC TR 62653:2020 supersedes IEC TR 62653:2006, which has been withdrawn. PD IEC TR 62653:2020 has some technical changes with respect to IEC TR 62653:2006. These include:
- Update the relevant references to the new numbering scheme of the ISO 23500 family
- Alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 62353:2014 and 60601-2-16:2018
- Technical additions in several sections
