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Standartų projektų portalas

Projekto etapai

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

Organizacija

CEN Europos standartizacijos komitetas

ICS

11.040.55 - Diagnostikos įranga

Technikos komitetas

TK 32 Sveikata

Užsienio technikos komitetas

CEN/TC 205

Komentarų skaičius

0

Komentavimo pradžia

2024-12-13

Taikymo sritis

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.