Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

Anästhesie- und Beatmungsgeräte - Anästhesie-Reservoirbeutel (ISO 5362:2024)

Dieses Dokument legt Anforderungen an Anästhesie-Reservoirbeutel für die Verwendung mit Anästhesie- und Beatmungsgeräten fest. Es enthält Anforderungen zur Ausführung der Muffe, zu den Größen und zur Elastizität.
Dieses Dokument ist nicht anwendbar für Beutel mit besonderen Zwecken, z. B. Bälge und selbstaufblasende Beutel und Beutel für den Gebrauch mit Anästhesiegas-Fortleitungssystemen.
Die Anforderungen in dieser gerätespezifischen Norm haben Vorrang vor jedweden gegenteiligen Anforderungen in der allgemeinen Norm für Atemwegsvorrichtungen (ISO 18190). Alle gemeinsamen Anforderungen, die in der allgemeinen Norm für Atemwegsvorrichtungen erscheinen, wurden aus diesem Dokument entfernt.

Matériel d’anesthésie et de réanimation respiratoire - Ballons réservoirs d’anesthésie (ISO 5362:2024)

Le présent document spécifie les exigences relatives aux ballons réservoirs d’anesthésie à usage unique et réutilisables, destinés à être utilisés avec des systèmes respiratoires d’anesthésie et de ventilateurs. Il inclut également des exigences relatives à la conception du col, à la désignation de la taille et à l’élasticité.
Le présent document n’est pas applicable aux réservoirs à usage spécial, par exemple les soufflets, les réservoirs autogonflables et les réservoirs utilisables avec des systèmes d'évacuation des gaz anesthésiques.
Les exigences mentionnées dans cette norme spécifique d’un dispositif prévalent sur les exigences contradictoires de la norme générale relative aux canules (ISO 18190). Toutes les exigences communes qui figurent dans la norme générale relative aux canules ont été supprimées du présent document.

Anestezijska in dihalna oprema - Dihalni baloni (ISO 5362:2024)

General Information

Status
Published
Publication Date
30-Jul-2024
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
31-Jul-2024
Completion Date
31-Jul-2024

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SLOVENSKI STANDARD
01-oktober-2024
Anestezijska in dihalna oprema - Dihalni baloni (ISO 5362:2024)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
Anästhesie- und Beatmungsgeräte - Anästhesie-Reservoirbeute (ISO 5362:2024)
Matériel d’anesthésie et de réanimation respiratoire - Ballons réservoirs d’anesthésie
(ISO 5362:2024)
Ta slovenski standard je istoveten z: EN ISO 5362:2024
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 5362
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5362:2019
English Version
Anaesthetic and respiratory equipment - Anaesthetic
reservoir bags (ISO 5362:2024)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Anästhesie-
Ballons réservoirs d'anesthésie (ISO 5362:2024) Reservoirbeutel (ISO 5362:2024)
This European Standard was approved by CEN on 12 May 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5362:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 5362:2024) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2025, and conflicting national standards shall
be withdrawn at the latest by January 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 5362:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 5362:2024 has been approved by CEN as EN ISO 5362:2024 without any modification.

International
Standard
ISO 5362
Fifth edition
Anaesthetic and respiratory
2024-07
equipment – Anaesthetic
reservoir bags
Matériel d’anesthésie et de réanimation respiratoire — Ballons
réservoirs d’anesthésie
Reference number
ISO 5362:2024(en) © ISO 2024
ISO 5362:2024(en)
© ISO 2024
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
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 5362:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Materials . 2
5.1 General .2
5.2 Biocompatibility evaluation of the breathing gas pathways .2
5.3 Material recommendations .2
6 Design requirements . 2
6.1 General .2
6.2 Designated size .2
6.3 Leakage .2
6.4 Necks .3
6.5 Tails .4
6.6 Elastic resistance .5
6.7 Elastic recovery .5
7 Requirements for anaesthetic reservoir bags supplied sterile . 5
8 Packaging. 5
9 Information supplied by the manufacturer . 6
9.1 General .6
9.2 Marking .6
Annex A (informative) Rationale . 7
Annex B (normative) Leakage test . 8
Annex C (normative) Determination of designated size . 9
Annex D (normative) Test for security of attachment of plain neck to a 22 mm cone conical
connector . 10
Annex E (normative) Test for security of attachment of adaptor of assembled neck .11
Annex F (normative) Test for elastic resistance and elastic recovery .12
Annex G (informative) Recommendations for materials .13
Annex H (informative) Hazard identification for risk assessment . 14
Bibliography .15

iii
ISO 5362:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
...

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