ISO/CD 12487
Medical electrical equipment — Clinical performance evaluation of clinical thermometers
Reference number
ISO/CD 12487
Edition 1
Committee Draft
ISO/CD 12487
A draft is being reviewed by the committee.


This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode.

This document covers both intermittently and continuously measuring clinical thermometers.

NOTE           For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient.

This document specifies additional disclosure requirements.

This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.

General information

  •  : Under development
    : CD approved for registration as DIS [30.99]
  •  : 1
  • ISO/TC 121/SC 3
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This standard contributes to the following Sustainable Development Goal

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