標準號：BS EN 60601-2-16-1998
中文標準名稱：醫用電氣設備.安全性詳細要求.血液透析設備,血液全過濾設備和血液過濾設備安全性的詳細要求
英文標準名稱：Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
標準類型：C45
發布日期：1998/7/15 12:00:00
實施日期：1998/7/15 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.20
適用范圍：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).