GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment (English Version)
Addition: This particular standard specifies the minimum safety requirements for single-use hemodialysis, hemodiafiltration and hemofiltration equipment (see the definition in 2.101). These devices are intended for use by medical personnel or under specialist supervision and include hemodialysis, hemodiafiltration and hemofiltration equipment operated by the patient. These particular requirements do not apply to — extracorporeal circuits, — dialyzers, — dialysate concentrates, — water purification equipment, — peritoneal dialysis equipment (IEC 60601-2-39:1999).
GB 9706.2-2003 history
2021GB 9706.216-2021 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
2003GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
1991GB 9706.2-1991 Medical electrical equipment--Particular requirements for safety of haemodialysis equipment