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About This Item

 

Full Description

BS EN ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.

This International Standard applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.


Cross References:
IEC 60598-1:2014
IEC 60601-1-9:2007
IEC 60601-1-6:2010
IEC 60601-1-10:2007
IEC 61950:2007
IEC 60529:1989+AMD1:1999
IEC 60601-1-3:2008
ISO 16571:2014
IEC 60601-1-8:2006+A1:2012
IEC 61386-1:2008
IEC 60364-5-54:2011
IEC 60601-1:2005+A1:2012
ISO 7396-1:2007
ISO 5359:2014
IEC 60601-1-2:2014
ISO 7396-2:2007
ISO 9170-1:2008
EN 50174-2:2009+A2:2014
ISO 9170-2:2008
ISO 14971:2007
ISO 3744:2010
EN 50174-1:2009+A2:2014
IEC 60364-7-710:2002
EN 61140
EN 13348
EN 60446


Incorporates the following:
Corrigendum, May 2018
 

Document History

  1. BS EN ISO 11197:2019


    Medical supply units

    • Most Recent
  2. BS EN ISO 11197:2016

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    Medical supply units

    • Historical Version
  3. BS ISO 11197:2016


    Medical supply units

    • Historical Version
  4. BS 12/30262133 DC


    BS EN ISO 11197. Medical supply units

    • Historical Version
  5. BS EN ISO 11197:2009


    Medical supply units

    • Historical Version
  6. BS EN ISO 11197:2004


    Medical supply units

    • Historical Version
  7. BS EN 793:1998


    Particular requirements for safety of medical supply units

    • Historical Version