SIST EN ISO 5367:2015
(Main)Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
*This International Standard specifies basic requirements for breathing sets and breathing tubes
intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers
or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied
already assembled and to those supplied as components and assembled in accordance with the
manufacturer’s instructions.
This International Standard is applicable to breathing sets which include special components (e.g.
water traps) between the patient end and machine end which are supplied already assembled.
This International Standard is not applicable to breathing sets and breathing tubes for special
purposes.
EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.
EXAMPLE 2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).
EXAMPLE 3 Breathing sets and breathing tubes with special connectors for neonatal ventilation.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets
and breathing tubes suitable for use with patient end adaptors.
NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat
and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by
this International Standard.
NOTE 2 ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1[3], ISO 23328-2[4], and ISO 5362[1] cover these.
NOTE 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 8185[2].
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2014)
Diese Internationale Norm legt grundlegende Anforderungen für antistatische und nicht-antistatische Atemsets und für Atemschläuche einschließlich Atemschläuche, die auf Länge zuzuschneiden sind, fest. Diese Atemsets und Atemschläuche sind zur Verwendung mit Anästhesiegeräten, Beatmungsgeräten, Anfeuchtern und Verneblern bestimmt sind. Sie gilt auch für Atemsets und Atemschläuche sowie Adapter am Patientenende, die entweder bereits konfektioniert oder als Bauteile zum Zusammenbau nach den Anweisungen des Herstellers geliefert werden.
Diese Internationale Norm gilt für Atemsets und Atemschläuche, an deren Enden Adapter mit konischen Verbindungsstücken eingebaut sind (konfektionierte Enden), und auch für Atemschläuche mit glatten Enden (zylindrische oder konische Enden).
Diese Internationale Norm gilt für Atemsets, die spezielle Bauteile (z. B. Wasserabscheider) zwischen dem Patientenende und dem Maschinenende, die bereits konfektioniert geliefert werden, enthalten.
Diese Internationale Norm gilt nicht für Atemsets und Atemschläuche für spezielle Zwecke, wie z. B. für Beatmungsgeräte mit speziellen Anforderungen an die Compliance, den Druck oder die Atemfrequenz.
ANMERKUNG 1 Beispiele für diese Anwendung Atemsets können Hochfrequenzbeatmung (High Frequency Oscillation Ventilation, HFOV) und Jet-Beatmung, (High Frequenzy Jet Ventilation, HFJV) sein.
Es wurden Festlegungen für koaxiale und zugehörige Atemsets, die sich gabeln, zweilumig sind oder mehrere Lumen besitzen, getroffen sowie für Atemschläuche, die für den Gebrauch mit Adaptern am Patientenende geeignet sind.
ANMERKUNG 2 Beispiele für verschiedene Arten von Atemsets mit Adaptern am Patientenende sind in Anhang A dargestellt.
Anforderungen an Ausatemventile, Absaugventile und einstellbare Druckbegrenzungsventile (APL-Ventil) sowie Reservoirbeutel, falls vorhanden, werden durch diese Norm nicht festgelegt.
ANMERKUNG 3 ISO 80601-0-12, ISO 80601-2-13 und ISO 5362 legen hierfür Anforderungen fest.
ANMERKUNG 4 Bestimmte Aspekte für beheizte Atemschläuche werden in ISO 8185 [1] behandelt.
Matériel d'anesthésie et de réanimation respiratoire - Circuits respiratoires et de connecteurs (ISO 5367:2014)
L'ISO 5367:2014 spécifie les exigences de base concernant les systèmes respiratoires et les tubes respiratoires destinés à être utilisés avec des systèmes respiratoires d'anesthésie, des systèmes respiratoires de ventilateurs, des humidificateurs ou des nébuliseurs. Elle s'applique aux systèmes respiratoires, tubes respiratoires et adaptateurs d'extrémité «patient» fournis déjà assemblés ainsi qu'à ceux qui sont fournis en tant que composants et assemblés conformément aux instructions du fabricant.
L'ISO 5367:2014 s'applique aux systèmes respiratoires qui incluent des composants spéciaux (par exemple, pièges à eau) entre l'extrémité «patient» et l'extrémité «appareil» qui sont fournis déjà assemblés.
Des dispositions ont été prises pour les systèmes respiratoires et les tubes respiratoires coaxiaux, à double branche, à double ou multiples lumières, destinés à être utilisés avec des adaptateurs d'extrémité «patient».
Anestezijska in dihalna oprema - Dihalni seti in priključki (ISO 5367:2014)
*Ta mednarodni standard določa osnovne zahteve za dihalne sete in cevke za dihanje, namenjene uporabi s sistemi za vdihavanje anestetika, ventilatorskimi dihalnimi sistemi, vlažilniki ali nebulatorji. Uporablja se za dihalne sete in cevke za dihanje ter priključke za pacienta, ki se dobavijo že sestavljeni, in za tiste, ki se dobavijo kot komponente ter se sestavijo v skladu z navodili proizvajalca.
Ta mednarodni standard se uporablja za dihalne sete, ki vključujejo posebne komponente (npr. sifone) med pacientom in aparatom, dobavljene že sestavljene. Ta mednarodni standard se ne uporablja za dihalne sete in cevke za dihanje za posebne namene. PRIMER 1: Ventilatorji s posebnimi zahtevami glede skladnosti, tlaka ali frekvence dihanja.
PRIMER 2: Visokofrekvenčno oscilacijsko predihavanje (HFOV) ali visokofrekvenčno pospešeno predihavanje (HFJV).
PRIMER 3: Dihalni seti in cevke za dihanje s posebnimi priključki za predihavanje novorojenčkov.
Predpisi so pripravljeni za koaksialne in povezane razcepljene, dvolumenske ali večlumenske dihalne sete in cevke za dihanje za uporabo s priključki za paciente.
OPOMBA 1: Primeri različnih tipov dihalnih setov s priključki za paciente so prikazani v dodatku A. Zahteve za ventile za izdihavanje, izpušne ventile, prilagodljive ventile za omejitev tlaka (APL), izmenjevalnike toplote in vlage (HME), dihalne filtre in zbiralne vrečke, če so zagotovljene, niso del tega mednarodnega standarda.
OPOMBA 2: Le-ti so obravnavani v standardih ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1[3], ISO 23328-2[4] in ISO 5362[1]. OPOMBA 3: Nekateri vidiki ogrevanih cevk za dihanje so obravnavani v standardu ISO 8185[2].
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5367:2015
01-januar-2015
1DGRPHãþD
SIST EN 12342:2000+A1:2009
$QHVWH]LMVNDLQGLKDOQDRSUHPD'LKDOQLVHWLLQSULNOMXþNL ,62
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO 5367:2014)
Matériel d'anesthésie et de réanimation respiratoire - Circuits respiratoires et de
connecteurs (ISO 5367:2014)
Ta slovenski standard je istoveten z: EN ISO 5367:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5367:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5367:2015
EUROPEAN STANDARD
EN ISO 5367
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.10 Supersedes EN 12342:1998+A1:2009
English Version
Anaesthetic and respiratory equipment - Breathing sets and
connectors (ISO 5367:2014)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Atemsets und
Systèmes respiratoires et raccords (ISO 5367:2014) Verbindungsstücke (ISO 5367:2014)
This European Standard was approved by CEN on 18 July 2014.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5367:2014 E
worldwide for CEN national Members.
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SIST EN ISO 5367:2015
EN ISO 5367:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 5367:2015
EN ISO 5367:2014 (E)
Foreword
This document (EN ISO 5367:2014) 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by October 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12342:1998+A1:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 5367:2014 has been approved by CEN as EN ISO 5367:2014 without any modification.
3
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SIST EN ISO 5367:2015
EN ISO 5367:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
standard.
Table ZA 1 — Correspondence between this European Document and Directive 93/42/EEC
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
5.1 7.1 (2nd, and 3rd indents)
4.3
5.1.1 7.2 5.1.1 mandates that these devices shall satisfy
the biological safety testing indicated in
7.1
ISO 10993-1
7.2
7.1 and 7.2 covers the integrity of the packaging
only for devices supplied sterile
4.1.1 7.3 first part 4.1.1, 4.1.2, and 5.1 mandates a risk
4.1.2 assessment be carried out which does not
exclude risks associated with materials and the
5.1
substances with which they may come into
contact.
5.1.3, 7.5 Partly addressed by 5.1.3 and 8.3.m) calls
8.3.m) specifically for a warning if phthalates are
incorporated
7.1, 8.1 Partly addressed. 7.1 and 8.3.a) mandate that
sterile devices are clearly marked according to
7.2,
EN 556–1 mandates the requirements of
8.3.a) ISO 11607-1 to ensure that the packaging is
suitable to prevent contamination during
transportation and use.
7.2 8.3 Partly addressed by 7.2 which mandates the
requirements of ISO 11607-1 that the packaging
is suitable to prevent contamination during
transportation and use.
7.1 8.4
4
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SIST EN ISO 5367:2015
EN ISO 5367:2014 (E)
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
7.1 8.5
8.3.a) 8.7 Partly covered. Marked sterile if appropriate
5.3 9.1 Generally covered by mandating construction
5.4 and testing of the interface connectors, leakage,
resistance, compliance, resistance to tube
5.5
collapse and kinking.
5.6
6
5.2 Partly covered to address only the risk of injury
9.2 (first three indents)
in connection with their physical features by
5.3
specifying sizing and marking conventions for
5.4
the ID/OD of the breathing tubes, and leakage,
resistance, and compliance when performance
5.5
tested in accordance with parameters
5.6
associated with a declared patient category.
8.3 c)
8.3 d), e), f), g), m)
8.4.1
8.4.2
8.4.3
8.4.5
5.3.1 12.7.4 Partly addressed for conical gas connectors
only.
5.3.2
5.3.3
5.3.5
5.3.6
8 13.1
8.1
8.2
8.3
8.4
8.1 13.2 Generally covered. Symbols are mandated in
8.1 to conform to EN 1041, ISO 7000 or
ISO 15223-1
8.2 a) 13.3 a)
8.3 i)
5
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SIST EN ISO 5367:2015
EN ISO 5367:2014 (E)
Clause(s)/sub- Essential Requirements Qualifying remarks/notes
clause(s) of this EN (ERs)
of Directive 93/42/EEC
8.3 c) 13.3 b) Covered for patient category, length, resistance,
total compliance and internal diameter.
8.3 d)
8.3 e) and f)
8.3 g)
8.3 h)
8.3 a) 13.3 c)
8.3 j) 13.3 d)
8.3.k) 13.3 e)
8.3.b) 13.3 f)
8.4.2 13.3 j) Partly addressed with requirements for
instructions for typical components or
8.4.3
processes.
8.4.4
8.4.5
8.3 l) 13.3 k)
8.3 m)
8.3 a) 13.3 m) Partly addressed. Method of sterilization is
addressed only as a recommendation.
8.4.5 13.5 Partly addressed. Limited to detachable
connectors, which are sized in accordance with
ISO 5356-1 instructs users on coaxial integrity
testing
8, 8.1, 8.2, 8.3, 8.4 13.6 , a), b), c)
8.4.4 13.6 h) Partly addressed. Risks associated with the
reuse of devices marked for single use are
8.3 l)
covered partly by the risk management file and
use of the informative Annex F Hazard
identification for risk assessment
8.4.5 13.6 i) Partly addressed. Details for coaxial set user
tests are mandated
8.4.6 13.6 q)
NOTE Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance to the Medical Devices Directive 93/42/EEC. This means that risks have
to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the
wording of the corresponding essential requirement
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard
6
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SIST EN ISO 5367:2015
INTERNATIONAL ISO
STANDARD 5367
Fifth edition
2014-10-15
Anaesthetic and respiratory
equipment — Breathing sets and
connectors
Matériel d’anesthésie et de réanimation respiratoire — Systèmes
respiratoires et raccords
Reference number
ISO 5367:2014(E)
©
ISO 2014
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SIST EN ISO 5367:2015
ISO 5367:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, 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
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E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 5367:2015
ISO 5367:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Risk management . 4
4.2 Usability . 4
4.3 Clinical evaluation . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
4.6 Recommended service life . 5
5 Specific requirements . 5
5.1 Materials . 5
5.2 Length . 5
5.3 Means of connection . 6
5.4 Leakage . 7
5.5 Resistance to flow . 7
5.6 Compliance . 8
6 Prevention of electrostatic charges . 9
7 Requirements for breathing sets and breathing tubes supplied sterile .9
7.1 Sterility assurance . 9
7.2 Packaging of breathing sets and breathing tubes supplied sterile. 9
8 Marking .10
8.1 General .10
8.2 Marking of breathing sets and breathing tubes .10
8.3 Marking of packages .10
8.4 Information to be supplied by the manufacturer .12
Annex A (informative) Rationale .13
Annex B (informative) Hazard identification for risk assessment .23
Annex C (normative) Test for security of attachment of plain end to conical connector .24
Annex D (normative) Test for security of attachment of adaptor to breathing tube .25
Annex E (normative) Test for leakage .26
Annex F (normative) Measurement of resistance to flow .28
Annex G (normative) Test for increase in flow resistance with bending .31
Annex H (normative) Test for compliance .33
Bibliography .35
© ISO 2014 – All rights reserved iii
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SIST EN ISO 5367:2015
ISO 5367:2014(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.
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 documents 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).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airways and related equipment.
This fifth edition cancels and replaces the fourth edition (ISO 5367:2000), which has been technically
revised.
The following major changes were made:
— title and scope;
— additional normative references;
— additional terms and definitions;
— additional general requirements, including risk management, usability, clinical and biophysical
research;
— requirements for coaxial tubing, revised leakage limits, and testing for flow resistance and
compliance;
— revised limits for prevention of electrostatic charges;
— revised requirements for marking of packaging, including the use of symbols, disclosure of intended
patient category, flow resistance and compliance;
— added an annex for rationale;
— added an annex for hazard identification for risk assessment;
— revised test method annexes for resistance to flow, security of attachments, leakage and compliance;
— added an annex for compliance with the EU Directives.
iv © ISO 2014 – All rights reserved
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SIST EN ISO 5367:2015
ISO 5367:2014(E)
Introduction
This International Standard contains requirements for breathing sets, breathing tubes, and connectors
that are intended to function as accessories to anaesthetic and respiratory equipment. Breathing sets
and breathing tubes are characterized by certain design requirements such as a means of connection
and leakage limits. Disclosure requirements for compliance and flow resistance values allow the user
to make an informed choice when connecting these accessories to a breathing system. These design
requirements are intended to allow operation within the limits of performance of the anaesthetic
breathing systems and ventilator breathing systems with which the accessories are intended to
operate.
This International Standard includes requirements for both single-use and reusable breathing sets
and breathing tubes. Re-usable breathing sets and breathing tubes are intended to comply with the
requirements of this International Standard for the recommended service life.
Certain tests are performed under constant pressure to simplify the test methodology. It is recognized
that this does not reflect clinical use, where pressure is intermittent and peak pressures occur for short
periods. The limits in the test methods take this into account. While such test methods do not address
product variability, the limits required also take this into account.
Terms defined in this International Standard are set in bold type.
Throughout this International Standard, text for which a rationale is provided in Annex A is indicated
by an asterisk (*).
Throughout this International Standard, all pressures are denoted in SI units of hPa with corresponding
cmH O equivalent values rounded to the nearest whole cmH O.
2 2
NOTE The unit cmH O is not an SI notation and is not used in ISO documents; rounded cmH O values are
2 2
given for information only to allow comparison to medical literature and related breathing system standards.
© ISO 2014 – All rights reserved v
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SIST EN ISO 5367:2015
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SIST EN ISO 5367:2015
INTERNATIONAL STANDARD ISO 5367:2014(E)
Anaesthetic and respiratory equipment — Breathing sets
and connectors
1 Scope
*This International Standard specifies basic requirements for breathing sets and breathing tubes
intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers
or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied
already assembled and to those supplied as components and assembled in accordance with the
manufacturer’s instructions.
This International Standard is applicable to breathing sets which include special components (e.g.
water traps) between the patient end and machine end which are supplied already assembled.
This International Standard is not applicable to breathing sets and breathing tubes for special
purposes.
EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.
EXAMPLE 2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).
EXAMPLE 3 Breathing sets and breathing tubes with special connectors for neonatal ventilation.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets
and breathing tubes suitable for use with patient end adaptors.
NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat
and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by
this International Standard.
[3] [4] [1]
NOTE 2 ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1 , ISO 23328-2 , and ISO 5362 cover these.
[2]
NOTE 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 8185 .
2 Normative references
*The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE See Annex A for information on the use of dated and undated normative references.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14971, Medical devices — Application of risk management to medical devices
© ISO 2014 – All rights reserved 1
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SIST EN ISO 5367:2015
ISO 5367:2014(E)
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
IEC 60417, Graphical symbols for use on equipment
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential
performance – Collateral standard: Usability
IEC 62366, Medical devices — Application of usability engineering to medical devices
ISO 80601-2-12:2011, Medical electrical equipment — Part 2-12: Particular requirements for basic safety
and essential performance of critical care ventilators
ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety
and essential performance of an anaesthetic workstation
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 1041, Information supplied by the manufacturer with medical devices
3 Terms and definitions
[5]
For the purposes of this document, the terms and definitions given in ISO 4135 and ISO 14971 and the
following apply.
3.1
adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible
components
[SOURCE: ISO 4135:2001, 4.2.3.1]
3.2
anaesthetic breathing system
inspiratory and expiratory gas pathways through which anaesthetic gas flows at respiratory pressure
between the fresh-gas inlet, the patient connection port and an exhaust valve or exhaust port
[SOURCE: ISO 80601-2-13:2011, 201.3.203]
3.3
antistatic
property of a material or procedure that disperses or inhibits the accumulation of electrostatic charges
3.4
APL valve
adjustable pressure-limiting valve
pop-off valve
pressure-limiting valve which releases gas over an adjustable range of pressures
[SOURCE: ISO 4135:2001, 4.3.6, modified]
3.5
assembled end
end of a breathing tube incorporating an adaptor
2 © ISO 2014 – All rights reserved
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SIST EN ISO 5367:2015
ISO 5367:2014(E)
3.6
breathing set
assembly of breathing tubes, connectors and components that form the inspiratory and expiratory
limbs of the gas pathways of an anaesthetic or ventilator breathing system between the ventilator
and the patient’s airway device
Note 1 to entry: The exhaust valve, heat and moisture exchanger (HME), breathing filter, and reservoir bag are
not included.
Note 2 to entry: The patient connection port is included.
3.7
breathing tube
non-rigid tube used to convey gases and/or vapours between components of a breathing system
[SOURCE: ISO 4135:2001, 4.1.2]
3.8
compliance
volume added per unit pressure increase when gas is added to an enclosed space, expressed at the
temperature and humidity of that enclosed space and at ambient atmospheric pressure
[SOURCE: ISO 4135:2001, 3.1.5]
3.9
machine end
that end of the breathing set or breathing tube intended to be connected to the anaesthetic workstation
...
SLOVENSKI STANDARD
oSIST prEN ISO 5367:2012
01-junij-2012
$QHVWH]LMVNDLQGLKDOQDRSUHPD'LKDOQLVHWLLQSULNOMXþNL ,62',6
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO/DIS
5367:2012)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO/DIS
5367:2012)
Matériel d'anesthésie et de réanimation respiratoire - Circuits respiratoires et de
connecteurs (ISO/DIS 5367:2012)
Ta slovenski standard je istoveten z: prEN ISO 5367
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5367:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 5367:2012
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oSIST prEN ISO 5367:2012
EUROPEAN STANDARD
DRAFT
prEN ISO 5367
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2012
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Breathing sets and
connectors (ISO/DIS 5367:2012)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Atemsets und
Circuits respiratoires et de connecteurs (ISO/DIS Verbindungsstücke (ISO/DIS 5367:2012)
5367:2012)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 215.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 5367:2012: E
worldwide for CEN national Members.
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oSIST prEN ISO 5367:2012
prEN ISO 5367:2012 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 5367:2012
prEN ISO 5367:2012 (E)
Foreword
This document (prEN ISO 5367:2012) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 5367:2012 has been approved by CEN as a prEN ISO 5367:2012 without any
modification.
3
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oSIST prEN ISO 5367:2012
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oSIST prEN ISO 5367:2012
DRAFT INTERNATIONAL STANDARD ISO/DIS 5367
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on Voting terminates on
2012-02-23 2012-07-23
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Anaesthetic and respiratory equipment — Breathing sets and
connectors
Matériel d'anesthésie et de réanimation respiratoire — Circuits respiratoires et de connecteurs
[Revision of fourth edition (ISO 5367:2000)]
ICS 11.040.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est
distribué en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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 NATIONAL REGULATIONS.
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.
© International Organization for Standardization, 2012
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oSIST prEN ISO 5367:2012
ISO/DIS 5367
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2012 – All rights reserved
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oSIST prEN ISO 5367:2012
ISO/DIS 5367
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 1BNormative references . 1
3 Terms and definitions . 2
4 3BGeneral requirements . 4
4.1 8BRisk management . 4
4.2 Usability . 5
4.3 Clinical evaluation . 5
4.4 Biophysical or modelling research . 5
4.5 9BTest Methods . 5
4.6 10BRecommended service life . 5
5 Specific requirements . 5
5.1 11BMaterials . 5
5.2 14BLength . 6
5.3 Means of connection . 6
5.4 17BLeakage . 7
5.5 18BResistance to flow . 8
5.6 19BCompliance . 9
6 4BPrevention of electrostatic charges . 9
7 5BRequirements for breathing sets and breathing tubes supplied sterile . 10
7.1 20BSterility assurance . 10
7.2 21BPackaging of breathing sets and breathing tubes supplied sterile . 10
8 6BMarking . 10
8.1 22BGeneral . 10
8.2 23BMarking of breathing sets and breathing tubes . 10
8.3 24BMarking of packages . 10
8.4 Information to be supplied by the manufacturer . 12
Annex A (informative) Rationale . 13
Annex B (informative) Hazard identification for risk assessment . 20
Annex C (normative) Test for security of attachment of plain end to conical connector . 21
Annex D (normative) Test for security of attachment of adaptor to breathing tube . 22
Annex E (normative) Test for leakage . 23
Annex F (normative) Measurement of resistance to flow . 25
Annex G (normative) Test for increase in flow resistance with bending . 28
Annex H (normative) Test for compliance . 30
Bibliography . 32
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 33
© ISO 2011 – All rights reserved iii
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oSIST prEN ISO 5367:2012
ISO/DIS 5367
Figures
Figure 1 — Axial length of plain end of breathing tube . 7
Figure A.1 — Example of a basic anaesthesia breathing set . 13
Figure A.2 — Example of a basic coaxial anaesthesia breathing set (i.e. Mapleson D-Bain) . 13
Figure A.3 — Example of a basic single tube breathing set with exhalation valve . 14
Figure A.4 — Example of a critical care ventilator breathing set with water traps and connections to a
humidifier (H) and ventilator (V) . 14
Figure A.5 — Example of a multiple lumen coaxial breathing set with gas sampling tubing . 15
Figure A.6 — VBS leakage limits by breathing system standard . 16
Figure A.7 — VBS leakage limits evaluated at the new pressure level . 17
Figure F.1 — Typical apparatus for measuring resistance to air flow . 26
Tables
*Table 1 — Leakage limit by patient category . 8
*Table 2 —Flow resistance limit by patient category . 8
Table 3 — Compliance limit per metre by intended delivered volume . 9
Table 4 — Compliance limit by intended delivered volume . 9
Table 5 — Patient categories . 12
Table F.1 — Test Flow Rates . 27
Table G.1 Test flow for flow resistance to bending . 28
Table ZA 1 — Correspondence between this European Document and Directive 93/42/EEC . 33
iv © ISO 2011 – All rights reserved
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oSIST prEN ISO 5367:2012
ISO/DIS 5367
1 Foreword
2 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
3 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
4 technical committees. Each member body interested in a subject for which a technical committee has been
5 established has the right to be represented on that committee. International organizations, governmental and
6 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
7 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
8 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
9 The main task of technical committees is to prepare International Standards. Draft International Standards
10 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
11 International Standard requires approval by at least 75 % of the member bodies casting a vote.
12 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
13 rights. ISO shall not be held responsible for identifying any or all such patent rights.
14 ISO 5367 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
15 Subcommittee SC 2, Airways and related equipment, Working Group (WG 3) which consisted of experts from
16 ISO/TC 121 subcommittees SC 1, SC 2, and SC 3.
17 This fifth edition cancels and replaces the fourth edition (ISO 5367:2000), which has been technically revised.
18 The following major changes were made:
19 - title and scope;
20 - additional normative references;
21 - additional terms and definitions;
22 - additional general requirements, including risk management, usability, clinical and biophysical research;
23 - requirements for coaxial tubing, revised leakage limits, and testing for flow resistance and compliance;
24 - revised limits for prevention of electrostatic charges;
25 - revised requirements for marking of packaging, including use of symbols, disclosure of intended patient
26 category, flow resistance, and compliance;
27 - added an annex for a rationale;
28 - added annex for hazard identification for risk assessment;
29 - revised test method annexes for resistance to flow, security of attachments, leakage, and compliance;
30 - added annex for compliance with the EU Directives.
31
32
© ISO 2011 – All rights reserved v
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oSIST prEN ISO 5367:2012
ISO/DIS 5367
33 Introduction
34 This International Standard contains requirements for breathing sets, breathing tubes, and connectors that are
35 intended to function as accessories to anaesthetic and respiratory equipment. Breathing sets and breathing
36 tubes are characterized by certain design requirements such as a means of connection and leakage limits.
37 Disclosure requirements for compliance and flow resistance values and labelling allow the user to make an
38 informed choice when connecting these accessories to a breathing system. These design requirements are
39 intended to allow operation within the limits of system performance of the anaesthetic breathing systems and
40 ventilator breathing systems with which the accessories are intended to operate.
41 This International Standard includes requirements for both single-use and reusable breathing sets and
42 breathing tubes. Re-usable breathing sets and breathing tubes are intended to comply with the requirements
43 of this International Standard for the recommended service life.
44 Certain tests are performed under constant pressure to simplify the test methodology. It is recognized that this
45 does not reflect clinical use, where pressure is intermittent and peak pressures occur for short periods. The limits
46 in the test methods take this into account. Whilst such test methods do not address product variability, the limits
47 required also take this into account.
48 Terms defined in this document are set in bold type.
49 Throughout this standard, text for which a rationale is provided in Annex A is indicated by an asterisk (*).
50 Throughout this standard, all pressures are denoted in SI units of hPa with corresponding cmH O equivalent
2
51 values rounded to the nearest whole cmH O.
2
52 NOTE The unit cmH O is not in SI notation and is not allowed in ISO documents; rounded cmH O values are given
2 2
53 for information only to allow comparison to medical literature and related breathing system standards.
54
55
vi © ISO 2011 – All rights reserved
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oSIST prEN ISO 5367:2012
DRAFT INTERNATIONAL STANDARD ISO/DIS 5367
56 Anaesthetic and respiratory equipment — Breathing sets and
57 connectors
58 1 Scope
59 * This International Standard specifies basic requirements for antistatic and non-antistatic breathing sets,
60 breathing tubes, and breathing tubes supplied to be cut to length, intended to be used with anaesthetic
61 apparatus and ventilators, humidifiers and nebulizers. It also applies to breathing sets and breathing tubes and
62 patient end adaptors supplied already assembled and to those supplied as components and assembled in
63 accordance with the manufacturers' instructions.
64 This International Standard is applicable to breathing sets and breathing tubes having ends incorporating
65 adaptors with conical connectors (assembled ends) or with plain ends (either cylindrical or tapered).
66 This International Standard is applicable to breathing sets which include special components (e.g. water traps)
67 between the patient end and machine end which are supplied already assembled.
68 This International Standard is not applicable to breathing sets and breathing tubes for special purposes, such
69 as those used with ventilators having special compliance, pressure, or breathing frequency requirements.
70 NOTE 1 Examples of these breathing sets may include High Frequency Oscillatory Ventilation, (HFOV), or High
71 Frequency Jet Ventilation (HFJV).
72 Provision is made for coaxial and related bifurcated, double lumen, or multiple lumen breathing sets and
73 breathing tubes suitable for use with patient end adaptors.
74 NOTE 2 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
75 Requirements for exhalation valves, exhaust valves, and adjustable pressure-limiting (APL) valves and
76 reservoir bags, if provided, are not covered by this standard.
77 NOTE 3 ISO 80601-2-12, ISO 80601-2-13 and ISO 5362 cover these.
[1]
78 NOTE 4 Certain aspects of heated wire breathing tubes are discussed in ISO 8185 .
79 2 1BNormative references
80 The following referenced documents are indispensable for the application of this document. For dated
81 references, only the edition cited applies. For undated references, the latest edition of the referenced
82 document (including any amendments) applies.
83 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
84 ISO 7000, Graphical symbols for use on equipment — Index and synopsis
85 ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk
86 management process
© ISO 2011 – All rights reserved
1
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ISO/DIS 5367
87 ISO 11607-1, Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile
88 barrier systems and packaging systems
89 ISO 14971, Medical devices – Application of risk management to medical devices.
90 ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
91 be supplied — Part 1: General requirements
92 IEC 60417, Graphical symbols for use on equipment
93 IEC 60601-1, Medical electrical equipment — Part 1: General requirements for safety.
94 IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential
95 performance – Collateral Standard: Usability
96 IEC 62366, Medical devices – Application of usability engineering to medical devices
97 ISO 80601-2-12, Medical Electrical Equipment — Part 2-12: Particular requirements for basic safety and
98 essential performance of critical care ventilators
99 ISO 80601-2-13, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and
100 essential performance of an anaesthetic workstation
101 EN 556-1, Sterilization of medical devices. Requirements for medical devices to be designated "STERILE".
102 Requirements for terminally sterilized medical devices
103 EN 980, Symbols for use in the labelling of medical devices
104 EN 1041, Information supplied by the manufacturer with medical devices
105 3 Terms and definitions
106 For the purposes of this International Standard, the following terms and definitions apply.
107 3.1
108 accessory
109 additional part for use with equipment in order to:
110 – achieve the INTENDED USE,
111 – adapt it to some special use,
112 – facilitate its use,
113 – enhance its performance, or
114 – enable its functions to be integrated with those of other equipment
115 [IEC 60601-1]
116 3.2
117 adaptor
118 specialized connector to establish functional continuity between otherwise disparate or incompatible components,
119 one end of which is intended to be inserted into the end of a breathing tube, the other end having a conical
120 connector complying with ISO 5356-1
[2]
121 [Adapted from ISO 4135 ]
122 3.3
123 anaesthetic breathing system
124 inspiratory and expiratory gas pathways through which anaesthetic gas flows at respiratory pressure between
125 the fresh-gas inlet, the patient connection port and an exhaust valve or exhaust port
© ISO 2011 – All rights reserved
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126 [ISO 80601-2-13]
127 3.4
128 antistatic
129 A property of material or a procedure that disperses or inhibits the accumulation of electostatic charges
130 3.5
131 APL valve
132 adjustable pressure-limiting valve
133 pop-off valve
134 pressure-limiting valve which releases gas over an adjustable range of pressures
135 [Adapted from ISO 4135]
136 3.6
137 assembled end
138 end of a breathing tube incorporating an adaptor
139 3.7
140 breathing set
141 assembly of breathing tubes, connectors and components that form the inspiratory and expiratory limbs of the
142 gas pathways of an anaesthetic or ventilator breathing system between the ventilator and the patient's
143 airway device
144 NOTE 1 The exhaust valve is not included
145 NOTE 2 The patient connection port is included
146 [Adapted from ISO 4135:2001, definitions 3.1.6 and 4.1.1, ISO 80601-2-12, definition 201.3.221, and ISO
147 80601-2-13, definition 201.3.203]
148 3.8
149 breathing tube
150 non-rigid tube used to convey gases and/or vapours between components of a breathing system
151 [ISO 4135]
152 3.9
153 compliance
154 volume added per unit pressure increase when gas is added to an enclosed space, expressed at the temperature
155 and humidity of that enclosed space and at an ambient atmospheric pressure
156 [ISO 4135]
157 3.10
158 machine end
159 that end of the breathing set or breathing tube which is intended to be connected to the anaesthetic workstation,
160 ventilator or other breathing system accessory furthest from the patient
161 3.11
162 patient connection port
163 opening at the patient end of a breathing system intended for connection of an airway device such as a tracheal
164 or tracheostomy tube connector, a face mask, a supralaryngeal airway or a test apparatus
165 [Adapted from ISO 4135:2001, 4.2.1.2.]
© ISO 2011 – All rights reserved
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166 3.12
167 patient end
168 that end of the breathing set or breathing tube which is intended to be connected to the patient end
169 adaptor, Y-piece or other appropriate component near the patient
170 3.13
171 *patient end adaptor
172 tubular connector with multiple ports, one of which is a patient connection port
173 [ISO 4135]
174 NOTE Examples of patient end adaptors include a Y-piece, a swivel adaptor, and other specialized adaptors for
175 coaxial, multiple tubes, and bifurcated tubes. See also Annex A Figures A.1 – A.5)
176 3.14
177 plain end
178 end of a breathing tube designed to fit directly over a male conical connector complying with ISO 5356-1
179 3.15
180 swivel adaptor
181 specialized connector which allows variation in the position of its ports relative to each other
182 [ISO 4135]
183 3.16
184 Y-piece
185 patient end adaptor as a 3-way connector with a patient connection port and two ports for connection to
186 breathing tubes
187 [ISO 4135]
188 3.17
189 VBS
190 ventilator breathing system
191 inspiratory or expiratory gas pathways through which gas flows at respiratory pressures and bounded by the
192 through which fresh gas enters, the patient-connection port and the exhaust port
193 [ISO 80601-2-12]
194 4 3BGeneral requirements
195 4.1 8BRisk management
196 4.1.1 This standard specifies requirements that are generally applicable to risks associated with breathing
197 sets and breathing tubes. An established risk management process shall be applied to the design of the
198 device.
199 NOTE An informative list of identified hazard
...
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