EN 60601-2-31

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Logo of the German Institute for Standardization DIN EN 60601-2-31
Area Medical technology
title Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external pacemakers with internal power supply
Latest edition 1.2009
ISO IEC 60601-2-31

The EN 60601-2-31 titled "Electrical Medical devices - Part 2-31: Particular requirements for basic safety and essential performance of external pacemakers with internal power supply" is part of the series of standards EN 60601 .

The DIN standard DIN EN 60601-2-31 is published by the German Institute for Standardization .

The standard is based on the international version IEC 60601-2-31. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-31 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for safety, tests and guidelines for external battery-operated pacemakers . The purpose is to describe features of the basic safety and the essential services, as well as tests and to give additional instructions for their application.

validity

The German edition 1.2009 has been accepted as a German standard from the date of its publication .

  • The current version (1.2009) is to be used in accordance with the 3rd edition of DIN EN 60601-1 .
  • The previous standard from October 1996 and the associated amendment A1 from May 1999 were withdrawn in January 2009, but may be used until June 2011 with the 2nd edition of DIN EN 60601-1.

scope of application

This International Standard applies to the basic safety including the essential performance characteristics of external pacemakers that are supplied by a device's own power supply, hereinafter referred to as ME device.

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 device and the ME system.

Devices that result 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 does not apply to the implantable parts of actively implantable medical devices that are dealt with in ISO 14708 . It does not apply to external pacemakers that can be directly or indirectly connected to the supply network and not to ME devices that stimulate via the thorax or the esophagus , or to ME devices for antitachycardia therapy (these are dealt with in: EN 45502-2-2 / VDE 0750-10-2).

extra information

The following changed requirements are contained in EN 60601-2-31 (extract):