EN ISO 5362:2024

SLOVENSKI STANDARD
oSIST prEN ISO 5362:2023
01-marec-2023
Anestezijska in dihalna oprema - Dihalni baloni (ISO/DIS 5362:2023)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO/DIS
5362:2023)
Anästhesie- und Beatmungsgeräte - Anästhesie-Reservoirbeutel (ISO/DIS 5362:2023)
Matériel d’anesthésie et de réanimation respiratoire - Ballons réservoirs d’anesthésie
(ISO/DIS-5362:2023)
Ta slovenski standard je istoveten z: prEN ISO 5362
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5362:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 5362:2023
oSIST prEN ISO 5362:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5362
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-01-13 2023-04-07
Anaesthetic and respiratory equipment – Anaesthetic
reservoir bags
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5362:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 5362:2023
ISO/DIS 5362:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5362
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
Anaesthetic and respiratory equipment – Anaesthetic
reservoir bags
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 5362:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

oSIST prEN ISO 5362:2023
ISO/DIS 5362:2022(E)
20 Contents
21 Foreword . 4
22 Introduction. 4
23 Scope . 6
24 2 Normative references . 6
25 3 Terms and definitions . 6
26 4 General requirements . 7
27 5 Materials . 7
28 5.1 General . 7
29 5.2 Biological evaluation of the breathing gas pathways . 7
30 5.3 Material recommendations. 7
31 6 Design requirements . 7
32 6.1 General . 7
33 Designated size . 7
6.2
34 6.3 Leakage . 7
35 6.4 Necks . 7
36 6.5 Tails . 8
37 6.6 Elastic resistance . 9
38 6.7 Elastic recovery . 9
39 7 Requirements for anaesthetic reservoir bags supplied sterile . 9
40 8 Packaging . 9
41 9 Information supplied by the manufacturer . 9
42 9.1 General . 9
43 9.2 Marking . 9
44 Annex A (informative) Rationale . 10
45 Annex B (normative) Leakage test . 11
46 Annex C (normative) Determination of designated size . 12
47 Annex D (normative) Test for security of attachment of plain neck to a 22 mm cone conical
48 connector . 13
49 Annex E (normative) Test for security of attachment of adaptor of assembled neck . 14
50 Annex F (normative) Test for elastic resistance and elastic recovery . 15
51 Annex G (informative) Recommendations for materials . 16
52 Annex H (informative) Hazard identification for Risk assessment . 17
53 Bibliography . 18
oSIST prEN ISO 5362:2023
ISO/DIS 5362:2022(E)
54 Foreword
55 ISO (the International Organization for Standardization) is a worldwide federation of national standards
56 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
57 through ISO technical committees. Each member body interested in a subject for which a technical
58 committee has been established has the right to be represented on that committee. International
59 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
60 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
61 electrotechnical standardization.
62 The procedures used to develop this document and those intended for its further maintenance are
63 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
64 different types of ISO documents should be noted. This document was drafted in accordance with the
65 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
66 Attention is drawn to the possibility that some of the elements of this document may be the subject of
67 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
68 patent rights identified during the development of the document will be in the Introduction and/or on
69 the ISO list of patent declarations received (see www.iso.org/patents).
70 Any trade name used in this document is information given for the convenience of users and does not
71 constitute an endorsement.
72 For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
73 expressions related to conformity assessment, as well as information about ISO's adherence to the World
74 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
75 www.iso.org/iso/foreword.html.
76 This document was prepared by Technical Committee 121, Anaesthetic and respiratory equipment
77 Subcommittee SC 2, Airways and related equipment.
78 This fifth edition cancels and replaces the fourth edition (ISO 5362:2006), which has been technically
79 revised.
80 The main changes compared to the previous edition are as follows:
81  this document has been rewritten to follow the format of ISO 18190 General requirements for
82 airways and related equipment. The requirements in this device-specific standard take
83 precedence over any conflicting requirements in the general standard. All common requirements
84 that appear in the General standard have been removed from this document.
85  the test method using water to test the pressure required to distend the anaesthetic reservoir bag
86 has been deleted and the alternative test method to test the pressure required to distend the
87 anaesthetic reservoir bag using air has been made normative;
88  the test method for leakage using air has been made normative.
89  neck adaptors can be either 22 mm cones or sockets
oSIST prEN ISO 5362:2023
ISO/DIS 5362:2022(E)
90 Introduction
91 This document is primarily concerned with the design of the neck, size designation, leakage and
92 resistance to pressure required to distend anaesthetic reservoir bags.
93 Flammable anaesthetic agents and gases are no longer in common use. However, this document still
94 includes requirements, through reference to the airway and related devices general standard ISO 18190
95 for electrical conductivity so that anaesthetic reservoir bags designed for use with flammable
96 anaesthetic agents/gases can still be manufactured.
97 Recommendations for materials are given in Annex G.
oSIST prEN ISO 5362:2023
ISO/DIS 5362:2022(E)
98 Anaesthetic and respiratory equipment – Anaesthetic reservoir
99 bags
100 1 Scope
101 This document specifies requirements for single-use and reusable anaesthetic reservoir bags for use with
102 anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size
103 designation, elasticity and, where relevant, electrical resistance.
104 This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags
105 for use with anaesthetic gas scavenging systems.
106 2 Normative references
107 The following documents are referred to in the text in such a way that some or all of their content
108 constitutes requirements of this document. For dated references, only the edition cited applies. For
109 undated references, the latest edition of the referenced document (including any amendments) applies.
110 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
111 ISO 18190:2016, Anaesthetic and respiratory equipment —
General requirements for airways and related
equipment
113 ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
114 Evaluation and testing within a risk management process
115 ISO 20417, Medical devices - Information to be supplied by the manufacturer
116 3 Terms and definitions
117 For the purposes of this document, the terms and definitions given in ISO 18190 and the following apply.
118 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
119 — IEC Electropedia: available at ht
...