Reference number
ISO 80601-2-56:2017
International Standard
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
Edition 2
2017-03
Read sample
ISO 80601-2-56:2017
67348
Published (Edition 2, 2017)
This standard has 1 amendment.

ISO 80601-2-56:2017

ISO 80601-2-56:2017
67348
Language
Format
CHF 173
Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

  •  : Published
     : 2017-03
    : International Standard to be revised [90.92]
  •  : 2
     : 49
  • ISO/TC 121/SC 3
    11.040.55 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2018

ISO 80601-2-56:2017/Amd 1:2018
75005
Language
Format
CHF 18
Convert Swiss francs (CHF) to your currency

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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