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IEC/TR 62653-ed.2.0
Guideline for safe operation of medical equipment used for haemodialysis treatments
Name übersetzen
NORM herausgegeben am 17.4.2020
Informationen über die Norm:
Bezeichnung normen: IEC/TR 62653-ed.2.0
Ausgabedatum normen: 17.4.2020
SKU: NS-992327
Zahl der Seiten: 36
Gewicht ca.: 108 g (0.24 Pfund)
Land: Internationale technische Norm
Kategorie: Technische Normen IEC
Kategorie - ähnliche Normen:
Transfusion, infusion and injection equipmentSyringes, needles and catheters
Die Annotation des Normtextes IEC/TR 62653-ed.2.0 :
IEC TR 62653:2020 is available as IEC TR 62653:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. 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. IEC TR 62653:2020 est disponible sous forme de IEC TR 62653:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis ledition precedente.
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