GOST R ISO 80601-2-55-2015
Medical electrical equipment. Part 2-55. Particular requirements for the basic safety and essential performance of respiratory gas monitorors

Standard No.
GOST R ISO 80601-2-55-2015
Release Date
2015
Published By
RU-GOST R
Latest
GOST R ISO 80601-2-55-2015

GOST R ISO 80601-2-55-2015 Referenced Document

  • IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
  • IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
  • IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance
  • IEC 60601-1-10:2007 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers
  • IEC 60601-1-11:2010 Medical electrical equipmentPart 1-11:General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  • IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
  • IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
  • IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-1-9:2007 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
  • IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • ISO 7000:2004 Graphical symbols for use on equipment - Index and synopsis
  • ISO 7010:2011 Graphical symbols - Safety colours and safety signs - Registered safety signs
  • ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

GOST R ISO 80601-2-55-2015 history

  • 2015 GOST R ISO 80601-2-55-2015 Medical electrical equipment. Part 2-55. Particular requirements for the basic safety and essential performance of respiratory gas monitorors



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