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EN 60601-2-28:2010 Standard

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  Keywords:

#subclause #clause #equipment #intended #systems

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosisIEC 60601-2-28:2010

  Purpose

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: – hereafter referred to as ME EQUIPMENT; – intended for medical diagnosis and imaging. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to Mem SYSTEMS, as relevant.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-2-28:1993"

Anyway is still possible use the "EN 60601-2-28:1993" until April 1st, 2013

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