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EN ISO 11197:2009 Standard

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  Keywords:

#applies #document #particular #take #requirements

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical supply units (ISO 11197:2004)

  Purpose

Clause 1 of EN 60601-1:1990 applies with the following addition: This document applies to medical supply units as defined in 3.5. This particular document applies in conjunction with EN 60601-1. The requirements of this particular document take priority over those of EN 60601-1.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 11197:2004"

Anyway is still possible use the "EN ISO 11197:2004" until March 21st, 2010

  Related Standards

EN 1641:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Materials

EN 60601-2-47:2001

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Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory e...

EN 60627:2001/AC:2002

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Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter gridsIEC 60627:2001

EN 60627:2001

Medical devices Directive (93/42/EEC)

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter gridsIEC 60627:2001

EN 60601-2-54:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipmen...

EN 60601-2-52:2010/AC:2011

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC ...

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