ISO/DIS 12487

This Draft International Standard is in the enquiry phase with ISO members.

ISO/DIS 12487

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Abstract

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

Status
: Under development

You can help develop this draft international standard by contacting your national member

Stage
: DIS ballot initiated: 12 weeks [40.20]
Edition
: 1

Number of pages
: 24
Technical Committee :
ISO/TC 121/SC 3

ICS :
11.040.55
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