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projektai-lsd Lithuanian Standards Board
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prEN ISO 12487

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

Draft Public enquiry
Comment end date 2025-02-11
Export comments Read draft and comment

Project stage codes

1. Decision on WI Proposal
2. Projektas
3. Viešoji apklausa
From 2024-12-13 till 2025-02-11
4. Closure of enquiry
5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.040.55 - Diagnostic equipment

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 205

Number of comments

0

Comment start date

2024-12-13

Scope

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.