標準號：IEC/TR 62653-2012
中文標準名稱：血液透析治療用醫療設備安全操作導則
英文標準名稱：Guideline for safe operation of medical equipment used for haemodialysis treatments
標準類型：C41
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C41
國際標準分類號：11.040.20;11.040.25
適用范圍：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 andprocesses 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.