JWG 8 - TC 62/SC 62D/JWG 8

ISO 12487:2026 This document specifies the requirements and methods for the clinical investigation of medical electrical (ME) equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE 1 This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode.
NOTE 2 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient.
This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document.
This document specifies additional disclosure requirements.
This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.
NOTE 3 ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.

IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph.
This edition includes the following significant technical changes with respect to the previous edition:
a) updates of the normative references and the bibliography;
b) expansion of the applicability to pandemic infectious diseases in general.

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.

ISO/TR 13154:2017(E) provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection.
NOTE The equipment standard for screening thermographs is found in IEC 80601-2-59.

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.

ISO/TR 13154:2009 provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for individual non-invasive febrile temperature screening of humans under indoor environmental conditions to prevent the spread of infection.