EN 80601-2-55

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Logo of the German Institute for Standardization DIN EN 80601-2-55
Area Medical technology
title Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of breathing gas monitors
Latest edition 5.2009 (draft)
ISO IEC 62D / 746 / CD: 2009

The EN 80601-2-55 with the title "Part 2-55: Special provisions for the safety including the essential performance characteristics of monitoring devices for breathing gases" is part of the EN 60601 series of standards (the EN-60601 series is currently being incorporated into EN-80601 Row transferred).

The DIN standard DIN EN 80601-2-55 is published by the German Institute for Standardization .

The standard is based on the international version IEC IEC 62D / 746 / CD: 2009. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-55 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines of monitoring devices for breathing gases. 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 .
  • The standard is intended to replace DIN EN ISO 21647 (VDE 0750-2-55) including all corrections (1 + 2).

scope of application

This standard applies to the basic safety and essential performance of monitoring devices for respiratory gases , RGM (s: respiratory gas monitor), hereinafter referred to as ME ME device and system which are intended for continuous use in humans.

This International Standard specifies requirements for:

  • Monitors for anesthetic gases;
  • Carbon dioxide monitors;
  • Oxygen monitors.

Monitoring devices designed for use with flammable anesthetic agents are outside the scope of this International Standard. Requirements of this International Standard that replace or change the requirements of EN 60601-1: 2005 take precedence over the corresponding general provisions.

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

The standard is still in the drafting stage. The following changed requirements are contained in EN 60601-2-55 (extract):

  • Protection against ingress of liquids and solids
  • Interruption of the power supply
  • Protection against dangerous initial values
  • Protection against mechanical hazards (safety against impacts and vibrations)
  • Safe handling of gases (leaks, pressure)
  • Electromagnetic compatibility
  • Alarms