EN 60601-2-57

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Logo of the German Institute for Standardization DIN EN 60601-2-57
Area Medical technology
title Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light sources for use in therapy, diagnosis, monitoring and for cosmetic / aesthetic purposes
Latest edition 2011-11
ISO IEC 76D / 403 / CDV: 2009

The EN 60601-2-57 with the title “Medical electrical equipment - Part 2-57: Special specifications for the safety including the essential performance characteristics of non-laser light sources for use in therapy, diagnosis, monitoring and for cosmetic / aesthetic Purposes "is part of the EN 60601 series of standards (the EN-60601 series is currently being transferred to the EN-80601 series).

The DIN standard DIN EN 60601-2-57 is published by the German Institute for Standardization .

The standard is based on the international version IEC IEC 76D / 403 / CDV: 2009. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-57 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for the safety, tests and guidelines of non-laser light sources for use in therapy, diagnosis, monitoring and for cosmetic / aesthetic purposes. 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 .

scope of application

This International Standard relates to the basic safety and essential performance characteristics of devices that contain one or more sources of optical radiation in the wavelength range from 200 nm to 3000 nm, with the exception of laser radiation , and which are intended to measure photobiological effects in humans or animals for therapeutic purposes. Generate diagnostic, monitoring, and cosmetic / aesthetic or veterinary applications; these devices are hereinafter referred to as light source devices (LS devices).

This standard does not apply to devices for tanning the skin, to ophthalmic instruments or other devices whose special safety problems are dealt with by corresponding international standards, and excludes devices intended for lighting.

The safety requirements set out in this International Standard only apply to hazards to the eye and skin; Risks to the internal tissues are outside the scope of application.

LS devices can contain one or more sources of optical radiation, with or without a power supply, or can be built into a complex system that includes optical, electrical or mechanical systems or other radiation sources.

This part of the standard 2-57 describes the minimum requirements; compliance with part 2-57 may be insufficient to achieve the required device safety level. Other safety or performance standards may apply to LS devices.

extra information

  • This standard is new and has no previous standard.
  • The standard is still in the drafting stage.

The following changed requirements are contained in EN 60601-2-57 (extract):

  • Classification
  • Labels
  • Protection against dangerous radiation
  • Accuracy and protection against dangerous initial values
  • Special dangers and 1st errors