EN 60601-2-22

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Logo of the German Institute for Standardization DIN EN 60601-2-22
Area Medical technology
title Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment
Latest edition 08.2015
ISO IEC 60601-2-22: 2007 + A1: 2012

The EN 60601-2-22 with the title "Medical electrical devices - Part 2-22: Special specifications for the safety of diagnostic and therapeutic laser devices" is part of the EN 60601 series of standards .

The DIN standard DIN EN 60601-2-22 is published by the German Institute for Standardization .

The standard is based on the international version IEC 60601-2-22. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-22 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for the safety, tests and guidelines of diagnostic and therapeutic laser devices .

validity

The German edition 08.2015 is accepted as a German standard from the date of its publication .

  • The version (12.1996) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
  • An amendment A1 was published in January 1998 (Tables 103 and 104 are affected).
  • A guide was published in October 2007 (corresponding to the 12.1996 edition). This guide is intended to provide help when applying EN 60601-2-22.
  • In November 2005 a draft for use with the 3rd edition of DIN EN 60601-1 was published.
  • The current edition 08.2015 is an adaptation to the structure and status of DIN EN 60601-1: 2007 with the associated supplementary standards, corresponding to the international version IEC 60601-2-22: 2007 + A1: 2012
  • When using it, the possible validity of the EN 60825 series must be observed.

scope of application

These special stipulations specify requirements for the safety of laser devices in medical use, classified as laser devices of class 3B or class 4 according to 3.17 and 3.18 of EN 60825-1, hereinafter referred to as laser devices.

Laser devices for medical use that are classified as class 1, 2 or 3A laser devices are covered by EN 60601-1 and IEC 60825-1.

extra information

The following changed requirements are contained in EN 60601-2-22 (excerpt):

  • Light and laser radiation
  • Accuracy of the operating data
  • Protection against dangerous output values
  • Error cases
  • Construction and construction