EN ISO 5362:2019
(Main)Anaesthetic reservoir bags (ISO 5362:2006)
Anaesthetic reservoir bags (ISO 5362:2006)
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-Reservoirbeutel (ISO 5362:2006)
Ballons réservoirs d'anesthésie (ISO 5362:2006)
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.
Dihalni baloni (ISO 5362:2006)
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
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2019
Nadomešča:
SIST EN 1820:2005+A1:2009
Dihalni baloni (ISO 5362:2006)
Anaesthetic reservoir bags (ISO 5362:2006)
Anästhesie-Reservoirbeutel (ISO 5362:2006)
Ballons réservoirs d'anesthésie (ISO 5362:2006)
Ta slovenski standard je istoveten z: EN ISO 5362:2019
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
September 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN 1820:2005+A1:2009
English Version
Anaesthetic reservoir bags (ISO 5362:2006)
Ballons réservoirs d'anesthésie (ISO 5362:2006) Anästhesie-Reservoirbeutel (ISO 5362:2006)
This European Standard was approved by CEN on 28 July 2019.
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, Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5362:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 5362:2006 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 5362:2019 by 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 March 2020, and conflicting national standards shall
be withdrawn at the latest by March 2020.
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 1820:2005+A1:2009.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 5362:2006 has been approved by CEN as EN ISO 5362:2019 without any modification.
INTERNATIONAL ISO
STANDARD 5362
Fourth edition
2006-06-01
Anaesthetic reservoir bags
Ballons réservoirs d'anesthésie
Reference number
ISO 5362:2006(E)
©
ISO 2006
ISO 5362:2006(E)
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©
ii ISO 2006 – All rights reserved
ISO 5362:2006(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Prevention of electrostatic charges . 4
6 Requirements for bags supplied sterile . 4
7 Marking . 4
8 Information to be supplied by the manufacturer . 5
Annex A (informative) Test for leakage . 6
Annex B (normative) Determination of capacity . 7
Annex C (normative) Test for security of attachment of plain neck to 22 mm male conical connector 8
Annex D (normative) Test for security of attachment of adaptor of assembled neck to bag . 9
Annex E (normative) Test for resistance to pressure required to distend the bag
(pressure/volume) . 10
Annex F (informative) Test for resistance to pressure required to distend the bag using air
(pressure/volume) . 11
Annex G (informative) Recommendations for materials . 12
Bibliography . 13
©
ISO 2006 – All rights reserved iii
ISO 5362:2006(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO5362 was prepared by Technical Committee ISO/TC121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Tracheal tubes and other equipment.
This fourth edition cancels and replaces the third edition (ISO 5362:2000), of which it constitutes a minor
revision.
©
iv ISO 2006 – All rights reserved
ISO 5362:2006(E)
Introduction
This International Standard is one of a series dealing with anaesthetic and respiratory equipment. This
International Standard is primarily concerned with the design of the neck, size designation and resistance to
pressure required to distend anaesthetic reservoir bags.
The requirement that reservoir bags should be electrically conductive, when used with a flammable anaesthetic,
is widely recognized and is of particular importance when such bags are rhythmically compressed by the
anaesthetic provider in order to provide intermittent positive-pressure ventilation.
This International Standard gives requirements for both antistatic and non-antistatic bags. Only antistatic bags
are suitable for use with flammable anaesthetic agents.
The reference test method given as Annex E is not practical for routine use in manufacturing control, because it
involves filling the bag with water. For this reason, another test method using air rather than water has been
provided for information in Annex F. This may ultimately be suitable as the reference test method if it can be
shown to give results equivalent to Annex E.
A test method for leakage of bags using air rather than water is given as Annex A for information only.
Recommendations for materials are given in Annex G.
©
ISO 2006 – All rights reserved v
.
vi
INTERNATIONAL STANDARD ISO 5362:2006(E)
Anaesthetic reservoir bags
1Scope
This International Standard 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.
This International Standard includes requirements for both single-use and reusable bags. Reusable bags are
intended to comply with the requirements of this International Standard for the recommended product life.
This International Standard 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 this International Standard.
2 Normative references
The following referenced documents are indispensable for the application 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 4287, Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions
and surface texture parameters
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
EN 556:1994, Sterilization of medical devices — Requirements for medical devices to be labelled “Sterile”
EN 980, Graphical symbols for use in the labelling of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
anaesthetic reservoir bag
collapsible gas container which is a component in a breathing system
[ISO 4135:2001, definition 4.1.3]
3.2
assembled neck
neck incorporating an adaptor
©
ISO 2006 – All rights reserved 1
ISO 5362:2006(E)
3.3
adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible
components, one end of which is intended to be inserted into the neck of the bag, the other end having a conical
connector complying with ISO 5356-1
3.4
plain neck
neck designed to fit directly over a male conical connector complying with ISO 5356-1
3.5
tail
tubular extension of the bag at the end opposite to the neck
4 General requirements
4.1 Reusable bags
Reusable bags shall comply with the requirements of this International Standard throughout the recommended
product life, as given in Cla
...
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