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.
IEC/TR 62653-2012由国际电工委员会 IX-IEC 发布于 2012-06。
IEC/TR 62653-2012 在中国标准分类中归属于: C41 医用超声、激光、高频仪器设备,在国际标准分类中归属于: 11.040.20 输血、输液和注射设备。
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