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EN 60601-1-3:2008/AC:2010 Standard

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  Keywords:

#equipment #medical #systems #electrical #applies

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipmentIEC 60601-1-3:2008

  Purpose

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of the PATIENT are used for diagnosis, planning or guidance of medical procedures.

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 60601-1-3:2008"

  Related Standards

EN ISO 10993-4:2009

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EN 80601-2-59:2009

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EN 80601-2-35:2009

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Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating device...

EN 62366:2008

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Medical devices - Application of usability engineering to medical devicesIEC 62366:2007

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