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 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2017 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2017 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. ISO 80601-2-56:2017 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 ISO 80601-2-56:2017.

Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps

S'applique à tous les équipements électroniques de commande, de régulation, de protection, d'alimentation etc, reliés à la batterie d'accumulateurs du véhicule ou à une source d'alimentation basse tension avec ou sans liaison galvanique avec la ligne de contact. Ne s'applique pas toutefois aux circuits électroniques de puissance qui doivent être conforme à la CEI 61287-1. Couvre les conditions de fonctionnement, la conception, la construction mécanique et les essais des équipements electroniques ainsi que les exigences de base du matériel et logiciel. Annule et remplace les CEI 60571-1, 60571-2, 60571-3.

General Information

Status
Published
Publication Date
21-Mar-2017
Current Stage
PPUB - Publication issued
Start Date
24-Apr-2017
Completion Date
22-Mar-2017
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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
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INTERNATIONAL ISO
STANDARD 80601-2-56
Second edition
2017-03
Medical electrical equipment —
Part 2-56:
Particular requirements for basic
safety and essential performance
of clinical thermometers for body
temperature measurement
Appareils électromédicaux —
Partie 2-56: Exigences particulières relatives à la sécurité
fondamentale et aux performances essentielles des thermomètres
médicaux pour mesurer la température de corps
Reference number
ISO 80601-2-56:2017(E)
©
ISO 2017

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ISO 80601-2-56:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

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ISO 80601-2-56:2017(E)
Contents Page
Foreword . v
Introduction . vi
201.1  * Scope, object and related standards . 1
201.1.1  Scope . 1
201.1.2  Object . 1
201.1.3  Collateral standards . 2
201.1.4  Particular standards . 2
201.2  Normative references . 3
201.3  Terms and definitions . 4
201.4  General requirements . 7
201.4.2  RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 7
201.4.3  ESSENTIAL PERFORMANCE . 8
Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements . 8
201.5  General requirements for testing of ME EQUIPMENT . 8
201.6  Classification of ME EQUIPMENT and ME SYSTEMS . 8
201.7  ME EQUIPMENT identification, marking and documents . 8
201.7.9  ACCOMPANYING DOCUMENT . 9
201.8  Protection against electrical HAZARDS from ME EQUIPMENT . 10
201.9  Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 10
201.10 Protection against unwanted and excessive radiation HAZARDS . 10
201.11 Protection against excessive temperatures and other HAZARDS . 11
201.11.7  Biocompatibility of ME EQUIPMENT and ME SYSTEMS . 11
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 12
201.12.1  Accuracy of controls and instruments . 12
201.12.2  Usability .
...

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