This specific standard specifies the minimum safety requirements for peritoneal dialysis equipment (see definition in 2.1.102, hereinafter referred to as equipment). This standard applies to equipment intended for use by medical personnel or under the supervision of a medical professional, including use in a hospital or in a home environment operated by a patient. This specific requirement does not apply to dialysate, dialysate lines and equipment intended for continuous ambulatory peritoneal dialysis only.
GB 9706.39-2008 history
2021GB 9706.239-2021 Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
2008GB 9706.39-2008 Medical electrical equipment.Part 2-39:Particular requirements for the safety of peritoneal dialysis equipment
GB 9706.39-2008 Medical electrical equipment.Part 2-39:Particular requirements for the safety of peritoneal dialysis equipment was changed to GB 9706.239-2021 Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.