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
Medical electrical equipment - Part 2: Particular requirements for the safety ofhaemodiafysis equipment
SIS SS-IEC 601-2-16-1991 中，可能用到以下仪器设备
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- 标准号
- SIS SS-IEC 601-2-16-1991
- 发布日期
- 1991年09月11日
- 实施日期
- 废止日期
- 无
- 发布单位
- SE-SIS
- 适用范围
- This clause of the General Standard applies except as follows: 1.1 Scope Addition: 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.