EN ISO 80601-2-56:2017

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)

Publication date:   Nov 15, 2017

General information

60.60 Standard published   Jul 26, 2017

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.55   Diagnostic equipment

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Scope

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients.
Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment.
Me equipment that measures a body temperature is inside the scope of this document.
ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4].
If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.
Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1.
NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 80601-2-56:2012

NOW

PUBLISHED
EN ISO 80601-2-56:2017
60.60 Standard published
Jul 26, 2017

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 80601-2-56:2017/A1:2020

REVISED BY

IN_DEVELOPMENT
prEN ISO 80601-2-56 rev