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ISO 80601-2-55:2018

(Main)

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.
ISO 80601-2-55:2018 specifies requirements for
- anaesthetic gas monitoring,
- carbon dioxide monitoring, and
- oxygen monitoring.
NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.
ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents.
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+Amd 1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601‑1:2005+Amd 1:2012, 4.2.

Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires

ISO 80601-2-55:2018 spécifie les exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoire (mgr), désignés ci-après par appareils em, destinés à être utilisés en service continu sur un patient.
ISO 80601-2-55:2018 spécifie les exigences relatives au:
- monitorage des gaz anesthésiques;
- monitorage du dioxyde de carbone; et
- monitorage de l'oxygène.
NOTE 1 Un mgr peut être soit un appareil em autonome, soit un appareil em intégré à un autre appareil, par exemple un poste de travail d'anesthésie ou un ventilateur.
Les mgr destinés à être utilisés avec des agents anesthésiques inflammables ne font pas partie du domaine d'application du présent document.
Si un article ou paragraphe est spécifiquement destiné à ne s'appliquer qu'aux appareils em ou aux systèmes em, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique aux appareils em et aux systèmes em, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils em ou des systèmes em dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques dans le présent document, à l'exception des paragraphes 7.2.13 et 8.4.1 de l'IEC 60601‑1:2005+Amd 1:2012.
NOTE 2 Des informations supplémentaires peuvent être consultées dans l'IEC 60601‑1:2005+Amd 1:2012, 4.2.

General Information

Status
Published
Publication Date
11-Feb-2018
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
SC 62D - Particular medical equipment, software, and systems
Drafting Committee
JWG 6 - TC 62/SC 62D/JWG 6
Current Stage
PPUB - Publication issued
Start Date
20-Apr-2018
Completion Date
14-Feb-2018
Ref Project

Relations

Revises
ISO 80601-2-55:2011 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Effective Date
05-Sep-2023

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ISO 80601-2-55:2018 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitorsISO 80601-2-55:2018 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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ISO 80601-2-55:2018 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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INTERNATIONAL ISO
STANDARD 80601-2-55
Second edition
2018-02
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic
safety and essential performance of
respiratory gas monitors
Appareils électromédicaux —
Partie 2-55: Exigences particulières relatives à la sécurité de base et
aux performances essentielles des moniteurs de gaz respiratoires
Reference number
ISO 80601-2-55:2018(E)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 80601-2-55:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 80601-2-55:2018(E)
Contents Page
Foreword .iv
Introduction .vi
201.1  Scope, object, and related standards . 1
201.2  Normative references . 3
201.3  Terms and definitions . 4
201.4  General requirements . 6
201.5  General requirements for testing of ME EQUIPMENT . 7
201.6  Classification of ME EQUIPMENT and ME SYSTEMS . 7
E EQUIPMENT identification, marking, and documents . 7
201.7  M
201.8  Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9  Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10Protection against unwanted and excessive radiation HAZARDS . 14
201.11Protection against excessive temperatures and other HAZARDS . 14
201.12Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13HAZARDOUS SITUATIONS and fault conditions . 22
201.14PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
201.15Construction of ME EQUIPMENT . 22
201.16ME SYSTEMS . 24
201.17Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
201.101  *Interfering gas and vapour effects . 24
201.102  *Gas leakage . 25
201.103  *Port connectors for DIVERTING RGMs . 25
201.104  *Sampling flowrate . 25
201.105  *Contamination of breathing systems . 25
201.106  FUNCTIONAL CONNECTION . 25
202  Electromagnetic disturbances — Req
...

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[1] Numbers in square brackets refer to the Bibliography.
[2] Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018.
[3] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.

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