BS EN 60601-2-16-1998 医用电气设备.安全性详细要求.血液透析设备,血液全过滤设备和血液过滤设备安全性的详细要求

标准号：BS EN 60601-2-16-1998
中文标准名称：医用电气设备.安全性详细要求.血液透析设备,血液全过滤设备和血液过滤设备安全性的详细要求
英文标准名称：Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
标准类型：C45
发布日期：1998/7/15 12:00:00
实施日期：1998/7/15 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.20
适用范围：Addition: This particular standard specifies the minimum safety requirements for single PATIENT HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION equipment (as defined in 2.101). These devices are intended for use either by medical staff or under the supervision of medical expertise, including HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT operated by the PATIENT. These particular requirements do not apply to —EXTRACORPOREAL CIRCUITS, —DIALYSERS, —DIALYSING FLUID CONCENTRATES, —water purification EQUIPMENT, —EQUIPMENT used to perform peritoneal dialysis (see IEC 60601-2-39).