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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 2024
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ii
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
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)
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Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment
Subcommittee SC 2, Airway devices and related equipment, in collaboration with the European Committee
for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 5362:2006), which has been technically
revised.
The main changes are as follows:
— the test method using water to test the pressure required to distend the anaesthetic reservoir bag has
been deleted and the alternative test method to test the pressure required to distend the anaesthetic
reservoir bag using air has been made normative;
— the test method for leakage using air has been made normative;
— conical cone neck adaptors have been added as an alternative to conical socket neck adaptors; and
— this document has been rewritten to follow the format of ISO 18190.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
This document is primarily concerned with the design of the neck, size designation, leakage and resistance
to pressure required to distend anaesthetic reservoir bags.
Flammable anaesthetic agents and gases are no longer in common use. However, this document still includes
requirements, through reference to the airway and related devices general standard ISO 18190 for electrical
conductivity so that anaesthetic reservoir bags designed for use with flammable anaesthetic agents/gases
can still be manufactured.
Recommendations for materials are given in Annex G.
v
International Standard ISO 5362:2024(en)
Anaesthetic and respiratory equipment – Anaesthetic
reservoir bags
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related
equipment
ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process
ISO 20417, Medical devices — Information to be supplied by the manufacturer
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18190 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible
components
[SOURCE: ISO 4135:2022, 3.1.4.1]
3.2
anaesthetic reservoir bag
collapsible and distensible gas container which is a component in an anaesthetic breathing system
[SOURCE: ISO 4135:2022, 3.6.1.3, modified — added “and distensible”.]
3.3
assembled neck
neck incorporating an adaptor (3.1)
3.4
plain neck
neck designed to fit directly over a conical cone connector conforming with ISO 5356-1
3.5
tail
tubular extension of the anaesthetic reservoir bag (3.2)
4 General requirements
The requirements of ISO 18190:2016, Clause 4, shall apply.
NOTE Annex H lists known hazards, associated with anaesthetic reservoir bags, that can
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