EN ISO 5361:2012
(Main)Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
same as ISO 5361
Anästhesie und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2012)
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 Sie werden durch ISO/TR 11991, ISO 11990 1, ISO 11990 2 und ISO 14408 abgedeckt [1] [2] [3] [4].
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords (ISO 5361:2012)
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki (ISO 5361:2012)
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 rameni, konusni sapnični tubusi in sapnični tubusi s sredstvi za sesanje, nadzorovanje ali dostavo 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. Trahiobronhialni (endobronhialni) tubusi, traheotomični tubusi in supralaringealne zračne poti so izključene iz 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-januar-2013
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SIST EN 1782:2000+A1:2009
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2012)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO 5361:2012)
Ta slovenski standard je istoveten z: EN ISO 5361:2012
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.
EUROPEAN STANDARD
EN ISO 5361
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Tracheal tubes and
connectors (ISO 5361:2012)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords (ISO 5361:2012) Verbindungsstücke (ISO 5361:2012)
This European Standard was approved by CEN on 15 September 2012.
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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5361:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
This document (EN ISO 5361:2012) 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 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 2013, and conflicting national standards shall be withdrawn at the
latest by October 2015.
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 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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 5361:2012 has been approved by CEN as a EN ISO 5361:2012 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 mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to Essential Requirements of
Directive 93/42/EEC on medical devices.
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.
NOTE 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 European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/notes
of this European Standard (ERs) of Directive 93/42/EEC
5.3 7.1 (2nd indent) In the EU, competent authorities always
require applicable ERs.
4.1.6 7.1 (3rd indent)
5.3.1 7.2 7.1 and 7.2 covers the integrity of the
packaging only for devices supplied
7.1
sterile.
7.2
4.1.1 7.3 4.1.1, 4.1.2, and 5.3 mandates a risk
assessment be carried out which does not
4.1.2
exclude risks associated with materials
and the substances with which they may
5.3
come into contact. Does not cover
devices intended to administer medicinal
products.
5.3.4 7.5 Partly addressed by 5.3.4 and 8.3.1 m),
calls specifically for a warning if
8.3.1 m)
phthalates are incorporated. However,
justification for the use of phthalates for
use with children or pregnant or nursing
women is not covered.
7.2 8.1 7.2 mandates the requirements of 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 7.1 mandates that sterile devices satisfy
4.1 of EN 556-1.
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/notes
of this European Standard (ERs) of Directive 93/42/EEC
7.1 8.5 7.1 mandates that sterile devices satisfy
4.1 of EN 556-1.
8.3.1 h) 8.7 Partly covered. Marked sterile if
appropriate.
5.2.2 9.1 Generally covered by mandating
construction and testing of the interface
5.5.4, 5.9, 5.5.1
connector, resistance to tube collapse
and kinking, and cuff leakage.
5.1 9.2 (first and second indent) Partly covered to address only the risk of
injury in connection with their physical
5.2
features by specifying sizing and marking
conventions for the ID/OD of the tracheal
Tables 1a), 1b), and 1c)
tube, curvature of the tube, marking for
5.5
the OD of the cuff, and pressure limits for
cuff performance testing.
5.7
8.3.2 b)
8.2.1.1 d), e), and f) 10.1 (first sentence) Partly covered to address length
measurement and marking in cm. Limits
of accuracy are specified in the standard
and not disclosed by the manufacturer.
8.2.1.1 d), e), and f) 10.2 Length marking positions are mandated to
provide ergonomic angular visibility during
intubation.
8.2.1.1 d), e), and f) 10.3 Length marking is mandated using SI
units (cm).
5.2.2.5 12.7.4 Tracheal tube gas connectors are
mandated to comply with ISO 5356-1 for
5.6.5
15 mm connectors.
Tracheal tube cuff inflation connectors are
mandated to comply with ISO 594-1 for
Luers.
8 13.1 Covered by mandating marking and
labelling and instructions on the tube,
connector, unit label, and instructions for
use. 4.2.1 Safety note draws attention to
4.2.1 NOTE
consideration of disclosure of specific
labelling and instructions for intended use
that may deviate from the currently
accepted medical practice.
8.1 13.2 Symbols are mandated in 8.1 to conform
to EN 1041 and ISO 7000 or EN 980 or
ISO 15223-1 and ISO 15223-2.
8.2.1.1 a) 13.3 a) Manufacturer identification mandated on
the device and on individual pack or any
8.3.1 f)
insert. Authorised representative
mandated on the individual pack or any
insert.
7.2 13.3 b) Only identifies that the device is sterile (if
applicable).
8.3.1 h)
8.3.1 h) 13.3 c)
Clause(s)/sub-clause(s) Essential Requirements Qualifying remarks/notes
of this European Standard (ERs) of Directive 93/42/EEC
8.3.1 g) 13.3 d) Batch code preceded by the word “LOT”
mandated for EU countries.
8.3.1 g) 13.3 e) ‘Use by date’ is only addressed via a
‘strong’ recommendation; The EU
regulation makes it mandatory.
8.3.1 i) 13.3 f)
4.2.1 NOTE 13.3 j) 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.
8.3.1 h) NOTE 13.3 m) This NOTE is mandatory to cover this ER.
8.4 13.5 Limited to detachable connectors, which
are marked with the designated tracheal
tube size.
8 13.6, a), b), c) Mandated markings, labelling and
instructions.
8.3.1 l) 13.6 h), first and second Mandated instructions for cleaning and
paragraphs 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
8.3.2 a) 13.6 i) Details for preparation for use are
mandated for disclosure.
8.3.2 c) 13.6 q) The date of issue of the latest revision of
instructions for use is mandated.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 5361
Second edition
2012-10-01
Anaesthetic and respiratory equipment —
Tracheal tubes and connectors
Matériel d’anesthésie et de réanimation respiratoire — Sondes
trachéales et raccords
Reference number
ISO 5361:2012(E)
©
ISO 2012
ISO 5361:2012(E)
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ii © ISO 2012 – All rights reserved
ISO 5361:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 *General requirements for tracheal tubes and tracheal tube connectors . 5
4.1 Risk assessment . 5
4.2 Safety . 6
5 Specific requirements for tracheal tubes and tracheal tube connectors . 6
5.1 Size designation . 6
5.2 Dimensions . 6
5.3 *Materials .14
5.4 Tracheal tube bevel .15
5.5 *Tracheal tube cuffs .15
5.6 Inflating system for cuffs .16
5.7 Curvature of the tube .16
5.8 *Radiopaqu
...
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