prEN ISO 12487

Respiratory equipment - Clinical investigation of clinical thermometers prEN ISO 12487

General information

10.99 New project approved   Mar 1, 2023

CEN

CEN/TC 205 Non-active medical devices

European Norm

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.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

NOW

IN_DEVELOPMENT
prEN ISO 12487
10.99 New project approved
Mar 1, 2023