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About This Item


Full Description

This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.

This document 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 61386-1:2008/AMD1:2017
IEC 60601-1:2005/AMD1:2012
IEC 60598-1:2014/AMD1:2017
IEC 60601-1-6:2010/AMD1:2013
ISO 9170-2:2008
IEC 60601-1-3:2008/AMD1:2013
ISO 14971:2019
ISO 3744:2010
ISO 9170-1:2017
ISO 5359:2014
ISO 32
EN 50174-1:2018
EN 50174-2:2018
ISO 7396-1:2016
IEC 60601-1-2:2014
ISO 7396-2:2007
IEC 60364-7-710:2002
IEC 62684 Ed.2.0
BS EN ISO 14971:2019
ISO 16571:2014
IEC 60529:1989+AMD2:2013 CSV/COR2:2015
EN 61140
EN 13348
IEC 60529:1989/AMD1:1999
IEC 60601-1-9:2007
IEC 60050-826:2004
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-10:2007
EN 62680-1-1:2015
IEC 60529:1989/AMD2:2013
ISO 19054:2006
IEC 61950:2007

All current amendments available at time of purchase are included with the purchase of this document.

Document History

  1. BS EN ISO 11197:2019


    Medical supply units

    • Most Recent
  2. BS EN ISO 11197:2016

    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