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IEC TR 62653

Guideline for safe operation of medical equipment used for haemodialysis treatments

inactive
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Organization: IEC
Publication Date: 1 June 2012
Status: inactive
Page Count: 34
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be complied with to ensure safe, permissible and proper application.

The physician is responsible for the HAEMODIALYSIS 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.

If applicable, the scope may be applicable to the use of the equipment in paediatrics, home HAEMODIALYSIS, acute and SORBENT DIALYSIS SYSTEMS.

The requirements of IEC 60601-2-16 ensure that 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 technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.

Document History

April 1, 2020
Guideline for safe operation of medical equipment used for haemodialysis treatments
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...
IEC TR 62653
June 1, 2012
Guideline for safe operation of medical equipment used for haemodialysis treatments
This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be complied with to ensure safe,...

References

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