STANDARD

Withdrawn

ÖNORM EN ISO 80601-2-56

Issue date: 2013 01 01

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)

IEC 60601-1:2005, Clause 1 applies, except as follows: Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard 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 standard does not apply to auxiliary equipment. ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard. Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME EQUIPMENT is not covered by this standard. 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 standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1.

General information on ÖNORM EN ISO 80601-2-56

Format
Digital | 60 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 80601-2-56 from 2000 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 14155-1:2003
Titel
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Ausgabedatum
2003 02 26
Art
Standard
Dokumentnummer
ISO 14155-2:2003
Titel
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Ausgabedatum
2003 05 16
Art
Standard
Dokumentnummer
ISO 15223-1:2007
Titel
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
Ausgabedatum
2007 04 04
Art
Standard

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