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CEN

EN 1282-2:2005

(Main)

Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

This document specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given.
This document is not applicable to specialized tracheostomy tubes.

Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert)

Diese Europäische Norm legt Anforderungen an pädiatrische Tracheotomietuben aus Kunststoffen und/oder
Gummi mit einem Innendurchmesser von 2,0 mm bis 6,0 mm fest. Es enthält auch Anforderungen an
Verbindungsstücke und Adapter für pädiatrische Tracheotomietuben.
Spezial-Tracheotomietuben gehören nicht zum Anwendungsbereich dieses Dokuments.

Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)

La présente Norme européenne spécifie les prescriptions relatives aux tubes de trachéostomie pédiatriques
en matière plastique et/ou en caoutchouc dont le diamètre intérieur est compris entre 2,0 mm et 6,0 mm. Les
prescriptions relatives aux raccords et adaptateurs de tubes de trachéostomie pédiatriques sont également
spécifiées.
Le présent document ne s�applique pas aux tubes de trachéostomie spécialisés.

Traheostomske cevke - 2. del: Cevke, ki se uporabljajo pri otrocih (ISO 5366-3:2001, spremenjen)

General Information

Status
Withdrawn
Publication Date
31-May-2005
Withdrawal Date
11-Aug-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
12-Aug-2009
Completion Date
12-Aug-2009
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 1282-2:2005 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

Relations

Replaces
EN 1282-2:1997 - Tracheostomy tubes - Part 2: Pediatric tubes
Effective Date
22-Dec-2008
Merged Into
EN 1282-2:2005+A1:2009 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Effective Date
19-Jan-2023
Amended By
EN 1282-2:2005/prA1 - Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
01-september-2005
1DGRPHãþD
SIST EN 1282-2:2000
Traheostomske cevke - 2. del: Cevke, ki se uporabljajo pri otrocih (ISO 5366-
3:2001, spremenjen)
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-3:2001, geändert)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée)
Ta slovenski standard je istoveten z: EN 1282-2:2005
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 1282-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2005
ICS 11.040.10 Supersedes EN 1282-2:1997
English version
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-
3:2001, modified)
Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 5366-
5366-3:2001, modifiée) 3:2001, geändert)
This European Standard was approved by CEN on 25 April 2005.

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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1282-2:2005: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Size designation and dimensions.6
4.1 Designation of size of tube .6
4.2 Outside diameter.6
4.3 Length .7
4.4 Angle θ .8
5 Materials .8
6 Design and finish.8
6.1 Machine end .8
6.2 Paediatric tracheostomy tube connector.8
6.3 Inner tube.9
6.4 Neck-plate.9
6.5 Cuff.9
6.6 Inflating tubes for cuffs.10
6.7 Patient end.10
6.8 Introducer .10
7 Requirements for tracheostomy tubes supplied sterile .10
7.1 Sterility assurance.10
7.2 Packaging for tracheostomy tubes supplied sterile .10
8 Marking .11
8.1 Marking of tracheostomy tube .11
8.2 Marking of tracheostomy tube connectors.11
8.3 Marking of unit packs.11
9 Adaptor .12
Annex A (normative) Test for security of attachment of permanently attached connector, if provided,
and neck-plate to tracheostomy tube.13
A.1 Principle.13
A.2 Apparatus .13
A.3 Procedure .13
A.4 Expression of results .14
Annex B (normative) Test method for determining the resting diameter of the cuff .15
B.1 Principle.15
B.2 Apparatus .15
B.3 Procedure .15
B.4 Expression of results .15
Annex C (informative) Guidance on materials and design.16
C.1 Materials .16
C.2 Design .16
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices .17
Bibliography .19

Foreword
The text of the International Standard ISO 5366-3:2001, including Corrigendum 1:2003 from Technical Committee
ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO)
has been taken over as a European Standard by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment”, the secretariat of which is held by BSI, with common modifications which are indicated by a straight
line in the margin of the text.
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 December 2005 and conflicting national standards shall be withdrawn at the latest
by December 2005.
This document supersedes EN 1282-2:1997.
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, 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.

Introduction
ISO 5366 is concerned with the basic requirements and method of size designation of tracheostomy tubes made of
plastics materials and/or rubber.
EN ISO 5366-1 gives requirements for adult tracheostomy tubes made of plastics materials and/or rubber.
This document gives requirements for paediatric tracheostomy tubes with an inside diameter from 2,0 mm to 6,0
mm.
Paediatric tracheostomy tubes are primarily intended for use with infants and children who may require anaesthesia,
artificial ventilation, relief of upper airway obstruction or other respiratory therapy.
An infant or child differs from an adult, not only in size but especially with regard to airway anatomy and respiratory
physiology; thus airway equipment for paediatric patients differs from that for adults in size and also in basic design.
It should be noted that, although this document gives some requirements for cuffs, cuffs are seldom provided on
the smaller sizes of paediatric tubes.
This document gives requirements for those characteristics of tracheostomy tubes that can be standardized and
which are important for patient safety. It does not require the connector to be permanently attached to the tube, as
this may be impractical with infants and small children. Other acceptable methods of connecting these components
are available, and this document makes provision for them. This document does not limit the range of tube designs
needed to match the variety of paediatric anatomy, lesions and space limitations encountered.
The method of describing tube dimensions and configuration has been devised with the aim of assisting the
clinician in the selection of a suitable tube to conform as far as possible to a particular patient's anatomy. Size is
designated by inside diameter, which is important because of its relation to resistance to gas flow. Because the
stomal and tracheal diameters are important when selecting tubes, it is considered essential that the outside
diameter be stated for each size of tube.
A tracheostomy tube can increase resistance to gas flow. For tubes with a given outside diameter, differences in
wall thickness have a major influence on the resistance to gas flow, especially in the smaller sizes of paediatric
tracheostomy tubes.
Flammability of tracheostomy tubes, for example if flammable anaesthetics, electrosurgical units or lasers are used
in oxidant-enriched atmospheres, is a well-recognized hazard addressed by appropriate clinical management,
which is outside the scope of this document.

See ISO/TR 11991.
1 Scope
This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials
and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube
connectors and adaptors are also given.
This document is not applicable to specialized tracheostomy tubes.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be labelled “STERILE”
EN ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO
5356-1:2004)
EN ISO 5366-1:2004, Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and
connectors for use in adults (ISO 5366-1:2000)
EN ISO 10993-1, Biological evaluation of medical devices — Pa
...

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This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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CEN
EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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