EN ISO 5361:2016
(Main)Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.
Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of ISO 5361:2016.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of ISO 5361:2016.
Anästhesie und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2016)
Diese Internationale Norm enthält die grundlegenden Leistungs- und Sicherheitsanforderungen an Orotracheal- und Nasotrachealtuben und an Verbindungsstücke für Trachealtuben. Trachealtuben mit durch Metall oder Nylon verstärkter Wand, Trachealtuben mit Schultern, konische Trachealtuben, Trachealtuben mit Möglichkeiten zum Absaugen, zum Überwachen oder zur Zufuhr von Medikamenten oder sonstigen Gasen und die zahlreichen anderen Arten von Trachealtuben für Spezialanwendungen wurden in diese Internationale Norm aufgenommen, da zahlreiche Spezial-Trachealtuben heutzutage häufig verwendet werden und für alle ähnliche grundlegende Anforderungen entsprechend dieser Internationalen Norm gelten.
Tracheobronchialtuben (Endobronchialtuben), Tracheostomietuben und supralaryngeale Atemwege sind vom Anwendungsbereich dieser Internationalen Norm ausgenommen.
Trachealtuben, die für die Anwendung mit brennbaren Anästhesiegasen oder -mitteln sowie Laser oder elektrochirurgischen Geräten bestimmt sind, sind nicht durch diese Internationale Norm abgedeckt.
ANMERKUNG Die Verweisungen [1] bis [4] decken diese Internationale Norm ab.
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords (ISO 5361:2016)
ISO 5361:2016 fournit les exigences essentielles de performance et de sécurité pour les sondes orotrachéales et nasotrachéales et les raccords de sonde trachéale. Les sondes trachéales à parois renforcées de métal ou de nylon, les sondes trachéales à épaulements, les sondes trachéales coniques, les sondes trachéales avec dispositifs pour aspiration, surveillance ou administration de médicaments ou d'autres gaz ainsi que les nombreux autres types de sondes trachéales conçus pour des applications spéciales sont inclus dans la présente Norme internationale, car de nombreuses sondes trachéales de spécialité sont maintenant d'usage courant et elles partagent toutes des exigences essentielles similaires à celles définies dans l'ISO 5361:2016.
Les sondes endobronchiques (trachéo-bronchiques), les canules de trachéotomie et les canules supralaryngiennes sont exclues du domaine d'application de l'ISO 5361:2016.
Les sondes trachéales destinées à être utilisées avec des gaz ou des agents anesthésiques inflammables, des équipements laser ou du matériel électrochirurgical ne relèvent pas du domaine d'application de l'ISO 5361:2016.
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki (ISO 5361:2016)
Ta mednarodni standard določa bistvene zahteve za učinkovitost in varnost ustnih ter nosnih sapničnih (endotrahealnih) tubusov in priključkov. V ta mednarodni standard so vključeni sapnični tubusi, ki imajo stene ojačane s kovino ali najlonom, sapnični tubusi z izboklinami, konusni sapnični tubusi in sapnični tubusi s sredstvi za sesanje, nadzorovanje ali dovajanje zdravil ali drugih plinov. Vključene so tudi druge vrste sapničnih tubusov za posebno uporabo, ker je trenutno v splošni uporabi veliko specializiranih sapničnih tubusov, pri čemer si vsi delijo podobne bistvene zahteve, ki so podane v tem mednarodnem standardu.
Endobronhialni (vključno s traheobronhialnimi) tubusi, traheostomski tubusi in supralaringealne dihalne cevke so izključene s področja uporabe tega mednarodnega standarda.
Sapnični tubusi, ki so namenjeni uporabi z vnetljivimi anestetičnimi plini ali anestetiki, ter laserska ali elektrokirurška oprema ne spadajo na področje uporabe tega mednarodnega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2016
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SIST EN ISO 5361:2013
SIST EN ISO 5361:2013/AC:2013
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
Anästhesieund Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO
5361:2016)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO 5361:2016)
Ta slovenski standard je istoveten z: EN ISO 5361:2016
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 5361
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 5361:2012
English Version
Anaesthetic and respiratory equipment - Tracheal tubes
and connectors (ISO 5361:2016)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords (ISO 5361:2016) Verbindungsstücke (ISO 5361:2016)
This European Standard was approved by CEN on 15 July 2016.
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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5361:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] . 5
European foreword
This document (EN ISO 5361:2016) 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 March 2017, and conflicting national standards shall
be withdrawn at the latest by September 2019.
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 ISO 5361:2012.
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.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
foreword and the Annexes ZZ.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed in
Clause 2
EN ISO/IEC
ISO 594-1 EN 20594-1:1993 + ISO 594-1:1986
AC:1993 + A1:1997
ISO 5356-1 EN ISO 5356-1:2015 ISO 5356-1:2015
ISO 7000 ISO 7000:2014
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 11135 EN ISO 11135:20104 ISO 11135:2014
ISO 11137-1 EN ISO 11137-1:2015 ISO 11137-1:2006 + AMD
1:2013
ISO 11607-1 EN ISO 11607-1:2009 + ISO 11607-1:2006 + AMD
A1:2014 1:2014
ISO 14155 EN ISO 14155:2011 ISO 14155:2011 + CORR
1:2011
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
1 1
ISO 15223-1
EN 15223-1:— ISO 15223-1:2015
ISO 15223-2 — ISO 15223-2:2010
EN 556-1:2001 EN 556-1:2001 —
EN 1041 EN 1041:2008 + A1:2013 —
ASTM F640-2007 — —
ASTM D3002-2007 — —
1 The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more
information, consult http://www.iso.org/iso/publications_and_e-products/databases.htm?=.
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 5361:2016 has been approved by CEN as EN ISO 5361:2016 without any modification.
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 Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] / [M/295 concerning
the development of European Standards related to medical devices] / [reference number and title of
any other standardization request as relevant] to provide one voluntary means of conforming to
essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ
L 160].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 1 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 with Directive 93/42/EEC as amended by 2007/47/EC. 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.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this International Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.1 (2nd indent) 5.3 7.1 (second indent)
Partly Covered. There are no
7.1 (3rd indent) 4.1.6
requirements for materials
apart for e requirements to
perform a risk assessment.
7.2 5.3.1 7.1 and 7.2 covers the integrity
of the packaging only for
7.1
devices supplied sterile.
7.2
7.3 5.3.1 5.3.1 and 5.3.1
5.3.3 First part covered; does not
cover devices intended to
administer medicinal products.
7.5 (second paragraph) 5.3.4
8.3.1 m)
8.1 7.2 Covered only for packaging of
sterile devices.
8.3 7.2 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.
8.4 7.1 7.1 mandates that sterile
devices satisfy 4.1 of EN 556-1.
8.7 8.3.1 h) Partly covered. Marked sterile
if appropriate.
9.1 5.2.2 Generally covered by
mandating construction and
testing of the interface
connector.
9.2 (first and second indent) 5.1 Partly covered to address only
the risk of injury in connection
5.2
with their physical features by
Tables 1a), 1b), and 1c)
specifying sizing and marking
conventions for the ID/OD of
5.5
the tracheal tube, curvature of
5.7
the tube, marking for the OD of
the cuff, and pressure limits
for cuff performance testing.
8.3.2 b)
10.1 (first sentence) 8.2.1.1 d) Partly covered to address
length measurement and
marking in cm.
10.2 8.2.1.1 d) Partly addressed. Length
marking positions are
8.2.1.2
mandated to provide
ergonomic angular visibility
during intubation. Glottic
depth marks aid in intubation
positioning.
10.3 8.2.1.1 d), and e) Length marking is mandated
using SI units (cm).
12.7.4 5.2.2.5 Tracheal tube gas connectors
are mandated to comply with
5.6.5
ISO 5356-1 for 15 mm
connectors.
Tracheal tube cuff inflation
connectors are mandated to
comply with ISO 594-1 for
Luers.
13.1 8 Covered by mandating
marking and labelling and
instructions on the tube,
connector, unit label, and
instructions for use. 4.2.1
13.3 b) 7.2 Only identifies that the device
is sterile (if applicable).
8.3.1 b)
Marking of 8.3.1 b), c) and d)
8.3.1 c)
on the unit pack will further
8.3.1 d)
address this requirement.
8.3.1 h)
13.3 c) 8.3.1 h)
13.3 d) 8.3.1 g) Batch code preceded by the
word “LOT” mandated for EU
countries.
13.3 e) 8.3.1 g) ‘Use by date’ is only addressed
via a ‘strong’ recommendation;
The EU regulation makes it
mandatory.
13.3 f) 8.3.1 i) For full coverage of this ER, the
NOTE in 8.1.1 I) is mandatory.
13.3 j) 4.2.1 NOTE 4.2.1 Safety note draws
attention to consideration of
disclosure of specific labelling
and instructions for intended
use that may deviate from the
currently accepted medical
practice. This NOTE is
mandatory to cover this ER.
13.3 m) 8.3.1 h) NOTE This NOTE is mandatory to
cover this ER.
13.5 8.4 Limited to detachable
connectors, which are marked
with the designated tracheal
tube size.
13.6, a) 8
Covers the following details
referred to in section 13.3
13.3a), b), c), f), and j).
For 13.3 m) to be covered the
recommendation in 8.3.1 h) is
mandatory.
13.6, b) 8 Covered in full
13.6, c) 5.2.2.5 8.3.1 b) requires the
description of the contents. Per
8.3.1 b)
5.2.2.5 the connector is
mandated to be a 15mm male
connector.
13.6 h), first and second 8.3.1 l) Mandated instructions for
paragraphs cleaning and disinfection or
sterilization. Risks associated
with the reuse of devices
marked for single use are
covered partly by the risk
management file and use of the
informative Annex F Hazard
identification for risk
assessment
13.6 i) 8.3.2 a) Details for preparation for use
are mandated for disclosure.
13.6 q) 8.3.2 c) The date of issue of the latest
revision of instructions for use
is mandated.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
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.
INTERNATIONAL ISO
STANDARD 5361
Third edition
2016-09-01
Anaesthetic and respiratory
equipment — Tracheal tubes and
connectors
Matériel d’anesthésie et de réanimation respiratoire — Sondes
trachéales et raccords
Reference number
ISO 5361:2016(E)
©
ISO 2016
ISO 5361:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be
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