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ISO 80601-2-56

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
ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2017 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2017 applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. ISO 80601-2-56:2017 does not apply to auxiliary equipment. ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56:2017.
BASE PUBLICATION

Technical committee

TC 62/SC 62D Particular medical equipment, software, and systems

Category

Safety
Publication typeInternational Standard
Publication date2017-03-22
Edition2.0
ICS

11.040.55

Stability date2024
Pages49
File size1.39 MB
EditionDatePublicationEditionStatus
  • Ensure healthy lives and promote well-being for all

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