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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

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Publication date: 2009-10-01
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ISO 80601-2-56:2009 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2009 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2009 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 80601-2-56:2009 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 80601-2-56:2009.Requirements for ME equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601‑2‑59:2008 and such ME equipment is not covered by ISO 80601-2-56:2009.
Document identifier
ISO 80601-2-56:2009
Title
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO Category
TC 121/SC 3: Lung ventilators and related equipment
Publication date
2009-10-01
Status
Ineffective
International Relationship
BS EN ISO 80601-2-56:2012 * DIN EN ISO 80601-2-56
Cross references
Latest version
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
Document identifier ISO 80601-2-56:2017
Publication date 2017-03-01
Classification 11.040.55. Diagnostic equipment
Status Effective
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History of version
ISO 80601-2-56:2017*ISO 80601-2-56:2009 * ISO 80601-2-56:2017 * ISO 80601-2-56:2009
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