ISO-80601-2-56 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 - 2ND EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

ORDER

Price:

$185.00        

To find similar documents by classification:

11.040.55 (Diagnostic equipment Including medical monitoring equipment, medical thermometers and related materials)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ISO 80601-2-56:2017

Revision Level

2ND EDITION

Status

Current

Publication Date

March 1, 2017

Committee Number

ISO/TC 121/SC 3