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SIST EN ISO 5362:2024

(Main)

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

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

ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.
ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life.
ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags.
Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

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

Dieses Dokument legt Anforderungen an Anästhesie-Reservoirbeutel zum einmaligen Gebrauch und zur Wiederverwendung für die Verwendung mit Anästhesie- und Beatmungsgeräten fest. Sie enthält Anfor
derungen zur Ausführung der Muffe, zu den Größen, zur Elastizität und gegebenenfalls zum elektrischen Widerstand.
Beutel für besondere Zwecke, z.B. Bälge und selbstaufblasende Beutel und Beutel für den Gebrauch mit Anästhesiegas-Fortleitungssystemen, gehören nicht zum Anwendungsbereich dieses Dokuments.

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

L'ISO 5362:2006 spécifie les exigences relatives aux ballons réservoirs antistatiques et non antistatiques destinés à être utilisés avec les appareils d'anesthésie ou les systèmes respiratoires de ventilateurs pulmonaires. Elle inclut également les exigences relatives à la conception du col, à la désignation de la taille, à la distension et, le cas échéant, les exigences relatives à la résistance électrique.
L'ISO 5362:2006 inclut des exigences relatives aux ballons réutilisables ou non réutilisables. Les ballons réutilisables doivent satisfaire aux exigences de l'ISO 5362:2006 pendant toute la durée de vie recommandée du produit.

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

Standard ISO 5362:2006 določa zahteve za antistatične ali neantistatične dihalne balone za uporabo z anestezijskim aparatom ali ventilatorskimi dihalnimi sistemi. Vključuje zahteve za zasnovo vratu, označevanje velikosti, razteznost in električno upornost, če je ustrezno.
Standard ISO 5362:2006 vključuje zahteve za balone za enkratno in večkratno uporabo. Baloni za večkratno uporabo morajo biti skladni z zahtevami standarda ISO 5362:2006 glede priporočljive življenjske dobe izdelkov.
Standard ISO 5362:2006 se ne uporablja za balone za posebne namene, na primer mehove in samoraztezne balone.
Baloni za uporabo s sistemi za odstranjevanje anestezijskih plinov se ne štejejo za dihalne balone, zato ne spadajo na področje uporabe standarda ISO 5362:2006.

General Information

Status
Published
Public Enquiry End Date
30-Mar-2023
Publication Date
18-Aug-2024
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
08-Aug-2024
Due Date
13-Oct-2024
Completion Date
19-Aug-2024
Ref Project
EN ISO 5362:2024 - Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)

Relations

Revises
SIST EN ISO 5362:2019 - Anaesthetic reservoir bags (ISO 5362:2006)
Effective Date
01-Dec-2021

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Standards Content (Sample)


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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Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024)
EN ISO 80369-2:2024

This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1        The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2        The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3        Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4        If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.

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SIST EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
EN ISO 16571:2024

Full revision of currently published 2014 version.  Additionally, expand scope to include plume evacuation systems for endoscopic procedures (e.g. minimally invasive, laparoscopic).
The scope is now the following:
This Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices. It is applicable to:
a) portable and mobile plume evacuation systems,
b) local stationary plume evacuation systems,
c) dedicated central pipeline systems for plume evacuation systems, and
d) plume evacuation systems integrated into other equipment (e.g. laser equipment).

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SIST EN ISO 81060-2:2020/A2:2024(Amendment)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
EN ISO 81060-2:2019/A2:2024
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SIST
SIST EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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