EN 80601-2-56

Area	Medical technology
title	Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of medical thermometers for measuring body temperature
Latest edition	5.2009 (draft)
ISO	IEC 62D / 613 / CD: 2007

The EN 80601-2-56 with the title "Part 2-56: Special provisions for the safety including the essential performance characteristics of medical thermometers for measuring body temperature" is part of the EN 60601 series of standards (the EN-60601 series is currently being integrated into the EN -80601 series transferred).

The DIN standard DIN EN 80601-2-56 is published by the German Institute for Standardization .

The standard is based on the international version IEC 62D / 613 / CD: 2007. Within the framework of the VDE standards, the standard is classified as VDE 0750-256 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines of medical thermometers for measuring body temperature. The purpose is to describe the features of basic safety, the essential performance features and tests and also to provide instructions for their application.

validity

The final version of the standard is to be used in accordance with the 3rd edition of DIN EN 60601-1 .
Appeals could be made until July 31, 2008.

scope of application

This International Standard specifies general, metrological and technical requirements for electrical medical thermometers . This International Standard applies to all electrical medical thermometers used to measure patient body temperature .

The medical thermometers can be equipped with interfaces for the integration of secondary displays, pressure devices and other additional devices and thus form ME systems. This International Standard does not apply to such accessories. ME devices that measure a temperature not as a primary task but as a secondary function are outside the scope of this international standard (e.g. Swan-Ganz thermodilution determination of cardiac output).

The requirements for ME devices that are to be used for non-invasive fever (temperature) screening of groups of people or individuals under indoor ambient conditions are specified in EN 80601-2-59 (currently draft).

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.

extra information

This standard is new and has no previous standard.
The draft standard EN 60601-2-56 (temperature measurements with thermal imaging cameras) is being further developed under the number EN 80801-2-59.
The standard is still in the drafting stage.

The following changed requirements are contained in EN 80601-2-56 (excerpt):

Accuracy of the displays and protection against dangerous output values
Laboratory performance requirements
Validation of clinical measurement accuracy