Supplement: This specific standard details the safety requirements for hemodialysis equipment for individual patients, as specified in clause 2.1.26. These devices are intended for use by medical personnel or as hemodialysis devices operated by patients under the supervision of a medical professional. These specific requirements do not apply to blood lines, hemodialyzers, dialysate concentrates, or water purification equipment.
GB 9706.2-1991 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