EN ISO 5366-1:2004
(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)
Anästhesie- und Beatmungsgeräte - Tracheotomietuben - Teil 1: Tuben und Verbindungsstücke zur Anwendung bei Erwachsenen (ISO 5366-1:2000)
Matériel d'anesthésie et de réanimation respiratoire - Tube de trachéostomie - Partie 1: Tubes et raccords pour adultes (ISO 5366-1:2000)
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-januar-2005
1DGRPHãþD
SIST EN 1282-1:2000
$QHVWH]LMVNDLQGLKDOQDRSUHPD±7UDKHRVWRPVNHFHYNH±GHO &HYNHLQ
SULNOMXþNL]DRGUDVOH ,62
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 - Tube de trachéostomie - Partie 1:
Tubes et raccords pour adultes (ISO 5366-1:2000)
Ta slovenski standard je istoveten z: EN ISO 5366-1:2004
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
July 2004
ICS 11.040.10 Supersedes EN 1282-1:1996
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 - Tube Anästhesie- und Beatmungsgeräte - Tracheotomietuben -
de trachéostomie - Partie 1: Tubes et raccords pour adultes Teil 1: Tuben und Verbindungsstücke zur Anwendugn bei
(ISO 5366-1:2000) Erwachsenen (ISO 5366-1:2000, korrigiert und neu
gedruckt im Jahre 2001)
This European Standard was approved by CEN on 21 June 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5366-1:2004: E
worldwide for CEN national Members.
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 EN ISO 5366-1:2004 by Technical Committee CEN/TC 215
"Respiratory and anaesthetic equipment", the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by January 2005, and conflicting national
standards shall be withdrawn at the latest by January 2005.
This document supersedes EN 1282-1:1996.
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 ZB, 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,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 5366-1:2000 has been approved by CEN as EN ISO 5366-1:2004 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN Year
ISO 594-1 1986 Conical fitings with a 6 % (Luer) taper EN 20594-1 1993
for syringes, needles and certain
other medical equipment – Part 1:
General requirements
ISO 4135 2001 Anaesthetic and respiratory EN ISO 4135 2001
equipment - Vocabulary
ISO 10993-1 1997 Biological evaluation of medical EN ISO 10993-1 1997
devices - Part 1: Evaluation and
testing
Annex ZB
(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.
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 normative clauses of this standard given in Table ZB.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.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
TABLE ZB.1 - Correspondence between this European Standard and EU
Directives
Clause/subclause of this Corresponding Essential Comments
European Standard Requirement of 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)
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
N/A = not applicable
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 national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical com-
mittees. 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 liai-
son with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this part of ISO 5366 may be the subject of patent
rights. ISO shall not be held responsible for ident
...
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