EN 60601-2-39
EN 60601-2-39, entitled "Medical electrical equipment - Part 2-39: Particular requirements for safety, including the essential features of peritoneal dialysis equipment", is part of the EN 60601 series.
The German Institute for Standardization is the editor of the DIN standard DIN EN 60601-2-39
The standard is based on the international version IEC 60601-2-39. Within the framework of the VDE standard, the standard is classified as VDE 0750-2-39, see DIN VDE standards Part 7
This supplementary standard regulates general requirements for the safety, testing and guidelines of peritoneal dialysis machines. The purpose is to describe features of basic safety as well as tests and to provide instructions for their application. Validity Edit the source text
The German edition 9.2008 has been adopted as a German standard from its date of appearance. Scope of Application Edit the source text
This international standard applies to basic safety and the essential performance characteristics of peritoneal dialysis ME devices, hereinafter referred to as PD devices. These PD devices are intended to be used either by medical personnel or under medical supervision, including PD devices that are operated by the patient regardless of whether they are used in the hospital or in the home. If a section or subsection is only intended specifically for use on ME devices or ME systems, this can be seen from the heading and content of the section or subsection. If this is not the case, the section or subsection, where applicable, applies to the ME devices and the ME systems. Hazards resulting from the intended physiological mode of operation of ME devices or ME systems within the scope of this standard are not covered by special requirements in this standard. This standard can also be applied to PD devices used to compensate or facilitate disease, injury or infirmity.
These particular requirements do not apply to the dialysis solution or the dialysis solution circuit. Edit additional information source text
The following amended requirements are contained in EN 60601-2-39 (excerpt):
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