EN ISO 5366-1:2009
(Main)Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
2019-02-19 - JO - TC decision 17/2018 (BT N 11332 - BT C160/2018) to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO.
Anästhesie- und Beatmungsgeräte - Tracheotomietuben - Teil 1: Tuben und Verbindungsstücke zur Anwendung bei Erwachsenen (ISO 5366-1:2000)
Dieser Teil von ISO 5366 gilt für Tracheotomietuben aus Kunststoffen und/oder Gummi mit einem Innendurchmesser
von mindestens 6,5 mm. Solche Tuben sind hauptsächlich für Patienten bestimmt, die eine
Anästhesie, künstliche Beatmung oder Atemunterstützung benötigen, ohne jedoch auf diese Anwendungsbereiche
beschränkt zu sein.
Dieser Teil von ISO 5366 gilt nicht für Spezialtuben. Entzündbarkeit von Tracheotomietuben ist nicht Gegenstand
von diesem Teil von ISO 5366.
Matériel d'anesthésie et de réanimation respiratoire - Tubes de trachéostomie - Partie 1: Tubes et raccords pour adultes (ISO 5366-1:2000)
L'ISO 5366-1:2000 fixe les prescriptions relatives aux tubes de trachéostomie en plastique et/ou en caoutchouc dont le diamètre intérieur est égal ou supérieur à 6,5 mm. L'usage de ces tubes est essentiellement réservé aux patients dont l'état nécessite une anesthésie, une respiration artificielle ou toute autre aide respiratoire, mais cet usage n'est pas restrictif.
L'ISO 5366-1:2000 ne s'applique pas aux tubes spéciaux et ne traite pas de l'inflammabilité des tubes de trachéostomie.
Anestezijska in dihalna oprema - Traheostomske cevke - 1. del: Cevke in priključki za odrasle (ISO 5366-1:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 5366-1:2005
$QHVWH]LMVNDLQGLKDOQDRSUHPD7UDKHRVWRPVNHFHYNHGHO &HYNHLQSULNOMXþNL
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Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and
connectors for use in adults (ISO 5366-1:2000)
Anästhesie- und Beatmungsgeräte - Tracheotomietuben - Teil 1: Tuben und
Verbindungsstücke zur Anwendung bei Erwachsenen (ISO 5366-1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Tubes de trachéostomie - Partie 1:
Tubes et raccords pour adultes (ISO 5366-1:2000)
Ta slovenski standard je istoveten z: EN ISO 5366-1:2009
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 5366-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 5366-1:2004
English Version
Anaesthetic and respiratory equipment - Tracheostomy tubes -
Part 1: Tubes and connectors for use in adults (ISO 5366-
1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Tubes Anästhesie- und Beatmungsgeräte - Tracheotomietuben -
de trachéostomie - Partie 1: Tubes et raccords pour adultes Teil 1: Tuben und Verbindungsstücke zur Anwendung bei
(ISO 5366-1:2000) Erwachsenen (ISO 5366-1:2000)
This European Standard was approved by CEN on 21 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5366-1:2009: 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
The text of ISO 5366-1:2000 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
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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 5366-1:2004.
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 EC Directive.
For relationship with EC Directive, 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, 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 and the United Kingdom.
Endorsement notice
The text of ISO 5366-1:2000 has been approved by CEN as a EN ISO 5366-1:2009 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 of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 – Correspondence between this European Standard and EU Directives
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
1 N/A
2 N/A
3 N/A
4 1, 2 a), 3
5 1, 2 a), 3, 7.1 a), 7.1 b), 7.2
6 1, 2, 3, 9.2 a)
6.1 4, 9.1, 9.3
6.1.1 7.5
6.1.4 7.5
6.2 4
6.3 9.1, 9.3
6.4.1 4
6.4.2 4
6.5.2.1 2 b)
6.5.3 9.1
6.7 4
7.1 8.1, 8.3, 8.4
7.2.2 5, 8.1, 8.3
8.1 13.2, 13.3 g) – m), 13.4
8.2 13.1
8.2.1 a) 13.3 b)
8.2.1 b) 13.3 b), 2 c)
8.2.1 c) 13.3 a)
8.3 13.1, 13.3 e)
8.3.1 13.2
8.3.2 a) 13.3 b), 13.4
8.3.2 b) 13.3 b)
8.3.2 d) 13.3 b)
8.3.2 e) 13.3 b)
8.3.2 f) 13.3 b)
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
8.3.2 g) 13.3 a)
8.3.2 h) 13.3 d), 13.5
8.3.2 i) 8.6, 13.6 h)
8.3.2 j) 8.1, 8.3, 8.7, 13.2, 13.3 b), c)
8.3.2 k) 13.3 b)
8.3.2 l) 2 c), 13.3 b)
8.3.3 13.3 e)
8.3.3 a) 13.3 b), 13.4
8.3.3 b) 13.3 b)
8.3.3 c) 13.3 b)
8.3.3 d) 13.3 a)
8.3.3 e) 13.3 d), 13.5
8.3.3 f) 8.6, 13.6 h)
8.3.3 g) 8.1, 8.3, 8.7, 13.2, 13.3 b), c)
8.3.3 h) 13.3 b), d) – f), 13.5
Annex C 4, 7.1 b), 7.3, 9.2 a)
C.1.2 13.6 h)
C.1.3 9.3
- 1 These parts of this
(2nd paragraph, 1st dash) Essential Requirement
are not addressed in this
(2nd paragraph, 2nd dash) Standard
- 6a) This part of this
Essential Requirement is
not addressed in this
Standard
- 7.1 (3rd dash) This part of this
Essential Requirement is
not addressed in this
Standard
- 7.5 (1st paragraph) This part of this
Essential Requirement is
not fully addressed in
this European Standard
- 7.5 (2nd paragraph) This part of this
Essential Requirement is
not fully addressed in
this European Standard
- 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this
European Standard
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
- 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 13.6 (h)(3rd paragraph) This relevant Essential
Requirement is not
addressed in this
European Standard
- 13.6 (q) This relevant Essential
Requirement is not
addressed in this
European Standard
N/A = not applicable
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 5366-1
Fourth edition
2000-12-15
Corrected and reprinted
2001-09-01
Anaesthetic and respiratory equipment —
Tracheostomy tubes —
Part 1:
Tubes and connectors for use in adults
Matériel d'anesthésie et de réanimation respiratoire — Tubes de
trachéostomie —
Partie 1: Tubes et raccords pour adultes
Reference number
ISO 5366-1:2000(E)
ISO 5366-1:2000(E)
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©
ii ISO 2000 – All rights reserved
ISO 5366-1:2000(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Size designation and dimensions . 4
5 Materials . 6
6 Design and finish . 6
7 Requirements for tracheostomy tubes supplied sterile . 7
8 Marking and labelling . 8
Annexes
A Test method for the security of attachment of connector and neck-plate to tracheostomy tube. 10
A.1 Principle . 10
A.2 Apparatus . 10
A.3 Procedure . 10
A.4 Expression of results . 10
B Test method for determining the resting diameter of the cuff. 11
B.1 Principle . 11
B.2 Apparatus . 11
B.3 Procedure . 11
B.4 Expression of results . 11
C Guidance on materials and design . 12
C.1 Materials . 12
C.2 Design . 12
Bibliography. 13
©
ISO 2000 – All rights reserved iii
ISO 5366-1:2000(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of nationa
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