ISO 80601-2-56:2017
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Standard No.
ISO 80601-2-56:2017
Release Date
2017
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 80601-2-56:2017/Amd 1:2018
Latest
ISO 80601-2-56:2017/Amd 1:2018

ISO 80601-2-56:2017 Referenced Document

  • ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
  • EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)
  • IEC 60601-1-11:2015 Medical electrical equipment - Part 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 60601-1-12:2014 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service
  • IEC 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment
  • 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 60601-2-19:2009 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
  • IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 80601-2-59:2008 Medical electrical equipment - Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening
  • ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 14159:2002 Safety of machinery - Hygiene requirements for the design of machinery
  • 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 15223-1:2016 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 9000:2015 Quality management systems - Fundamentals and vocabulary
  • ISO/IEC GUIDE 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

ISO 80601-2-56:2017 history

  • 2018 ISO 80601-2-56:2017/Amd 1:2018 Amendment 1 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
  • 2017 ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
  • 2009 ISO 80601-2-56:2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement



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