GB 9706.239-2021 Medical electrical equipment—Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Scope

This part of GB 9706 applies to the basic safety and basic performance of peritoneal dialysis medical devices (hereinafter referred to as PD devices) defined in 201.3.208. This part applies to PD devices intended to be used by medical personnel or under the supervision of medical experts, including PD devices operated by patients in hospitals or in home environments.
If a chapter or a clause explicitly states that it only applies to ME devices or ME systems, the title or text of the chapter or clause will indicate this. If this is not the case, the relevant chapter or clause applies to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
Note: See 4.2 of the general standard.
This part also applies to PD devices used to eliminate or alleviate diseases, injuries, or disabilities.
This part does not apply to dialysis solution or dialysis solution pipelines.

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