EN 60601-2-39

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Logo of the German Institute for Standardization DIN EN 60601-2-39
Area Medical technology
title Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis machines.
Latest edition 9/2008
ISO IEC 60601-2-39: 2008

The EN 60601-2-39 with the title "Medical electrical equipment - Part 2-39: Special stipulations for the safety including the essential performance features of peritoneal dialysis machines" is part of the EN 60601 series of standards .

The German Institute for Standardization is the publisher 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 standards, the standard is classified as VDE 0750-2-39 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines of peritoneal dialysis machines. The purpose is to describe features of the basic safety as well as tests and to give additional instructions for their application.

validity

The German edition 9.2008 is accepted as a German standard from the date of its publication .

  • The current version (9.2008) is to be used in accordance with the 3rd edition of DIN EN 60601-1 .
  • The previous edition of the standard (2.2000) is to be used in accordance with the 2nd edition of DIN EN 60601-1. Edition 2.2000 can still be used until 3.2011.

scope of application

This international standard applies to the 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 patient-operated, regardless of whether they are used in a hospital or home environment. 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 sub-section, where applicable, applies to the ME equipment and the ME systems. Hazards resulting from the intended physiological mode of action of ME devices or ME systems in the scope of this standard are not covered by special requirements in this standard. This standard can also be applied to PD devices that are used to compensate or relieve illness, injury or ailments.

These special stipulations do not apply to the dialysis solution or the dialysis solution circuit.

extra information

The following changed requirements are contained in EN 60601-2-39 (extract):

  • Accuracy of operating data and protection against dangerous output values.
  • construction