SIS SS-IEC 601-2-16-1991 医疗电气设备．第2部分：血液透析设备安全细则

标准号：SIS SS-IEC 601-2-16-1991
中文标准名称：医疗电气设备．第2部分：血液透析设备安全细则
英文标准名称：Medical electrical equipment - Part 2: Particular requirements for the safety ofhaemodiafysis equipment
发布日期：1991/9/11 12:00:00
实施日期：1999/12/31 12:00:00
适用范围：This clause of the General Standard applies except as follows:1.1 ScopeAddition:This Particular Standard specifies the safety requirements for single patient single pass haemodialysis equipment as defined in Sub-clause 2.1.26. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis equipment operated by the patient. These Particular Requirements do not apply to blood lines, haemodialysers, dialysing fluid concentrate or water purification equipment.