透析治疗中医疗产品安全使用指南

[中文适用范围]： 本技术报告描述了血液透析、血液滤过和血液透析滤过设备使用的技术要求。应遵守这些原则，以确保安全、允许和正确的应用。医生负责开具血液透析治疗处方。然而，实施治疗的组织对与治疗相关的所有资源、结构和流程负责。这里不再描述这些职责。如果适用，该范围可能适用于儿科、家庭血液透析、急性和吸附性透析系统中设备的使用。 IEC 60601-2-16 的要求确保用于体外肾脏替代治疗的设备以高安全水平运行。然而，尽管安全水平很高，但仍然存在一些与医学生物、物理化学和技术危害相关的残余风险。实施治疗的组织负责管理残余风险。本技术报告不作为监管检查或认证评估活动的依据。 [外文原描述]： IEC 62653:2012(E) which is a 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. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.