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
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.
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Laboratory performance requirements
1 * General test requirements
2 * Laboratory accuracy
3 * Time response for a continuous clinical thermometer
* Clinical accuracy validation
1 Method
2 * Human subject population requirements
3 * Clinical bias calculation
4 * Limits of agreement calculation
5 * Clinical repeatability calculation
* Probes, probe cable extenders and probe covers
1 General
2 Labeling
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Laboratory performance requirements
1 * General test requirements
2 * Laboratory accuracy
3 * Time response for a continuous clinical thermometer
* Clinical accuracy validation
1 Method
2 * Human subject population requirements
3 * Clinical bias calculation
4 * Limits of agreement calculation
5 * Clinical repeatability calculation
* Probes, probe cable extenders and probe covers
1 General
2 Labeling