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prEN ISO 12487

Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024)

General information

Draft
Base Documents
ISO/DIS 12487; prEN ISO 12487
Directives or regulations
None
You can view draft standards in the Commenting portal🡭.

Standard history

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Date
Type
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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.

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