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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)

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)

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
Publication Date
30-Jul-2024
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
31-Jul-2024
Completion Date
31-Jul-2024
Ref Project
SIST EN ISO 5362:2024 - Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)

Relations

Replaces
EN ISO 5362:2019 - Anaesthetic reservoir bags (ISO 5362:2006)
Effective Date
19-Jan-2023

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

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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CEN
EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST 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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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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CEN
EN ISO 80601-2-12:2023(Main)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
SIST EN ISO 80601-2-12:2024

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:
¾     intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 2      For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 3      For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 4      A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
¾     intended to be operated by a healthcare professional operator; and
¾     intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
NOTE 5     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+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 6     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 7     A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
NOTE 8     See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
¾     ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84;
¾     ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72;
¾     ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80;
¾     obstructive sleep a

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