prEN ISO 12487
Elektrinė medicinos įranga. Medicininių termometrų klinikinių charakteristikų įvertinimas (ISO/DIS 12487:2024)
Standarto projektas Viešoji apklausaProjekto 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 komitetasICS
11.040.55 - Diagnostikos įrangaTechnikos komitetas
TK 32 SveikataUžsienio technikos komitetas
CEN/TC 205Komentarų skaičius
0Komentavimo pradžia
2024-12-13Taikymo 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.