SIST EN ISO 8836:2009
(Main)Suction catheters for use in the respiratory tract (ISO 8836:2007, corrected version 2008-03-15)
Suction catheters for use in the respiratory tract (ISO 8836:2007, corrected version 2008-03-15)
This International Standard specifies requirements for suction catheters made of plastic materials and intended for use in suction of the respiratory tract. Specialized suction catheters, e.g. those with more than one lumen and suction catheters without a terminal orifice, are excluded from the scope of this International Standard. Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of this International Standard.
Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2007, Korrigierte Fassung 2008-03-15)
Diese Internationale Norm legt Anforderungen an Absaugkatheter aus Kunststoffen zur Verwendung im
Atemtrakt fest.
Diese Internationale Norm gilt nicht für Spezial-Absaugkatheter, z. B. Absaugkatheter mit mehr als einem
Lumen oder Absaugkatheter ohne Endöffnung.
Absaugkatheter mit abgewinkeltem Patientenende (z. B. Coudé-Katheter und Absaugkatheter mit Aspirator-
Sammlern werden nicht als Spezial-Absaugkatheter betrachtet und gehören deshalb zum Anwendungsbereich
dieser Internationalen Norm.
Sondes d'aspiration pour les voies respiratoires (ISO 8836:2007, version corrigée 2008-03-15)
L'ISO 8836:2007 spécifie les exigences pour les sondes d'aspiration constituées de matières plastiques et destinées à l'utilisation dans l'aspiration des voies respiratoires.
Les sondes d'aspiration spécialisées, par exemple celles comportant plus d'une lumière et les sondes d'aspiration sans orifice terminal, sont exclues du domaine d'application de la présente Norme internationale.
Les sondes d'aspiration à extrémité coudée (par exemple les sondes Coudé) et les sondes d'aspiration avec des collecteurs ne sont pas considérées comme étant spécialisées et elles sont donc incluses dans le domaine d'application de l'ISO 8836:2007.
Aspiracijski katetri za čiščenje dihalnih poti (ISO 8836:2007, popravljena verzija 15. 3. 2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8836:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 8836:2008
$VSLUDFLMVNLNDWHWUL]DþLãþHQMHGLKDOQLKSRWL ,62 SRSUDYOMHQDYHU]LMD
Suction catheters for use in the respiratory tract (ISO 8836:2007, corrected version 2008-
03-15)
Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2007, Korrigierte Fassung
2008-03-15)
Sondes d'aspiration pour les voies respiratoires (ISO 8836:2007, version corrigée 2008-
03-15)
Ta slovenski standard je istoveten z: EN ISO 8836:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 8836:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8836:2009
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SIST EN ISO 8836:2009
EUROPEAN STANDARD
EN ISO 8836
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.25; 11.040.10 Supersedes EN ISO 8836:2008
English Version
Suction catheters for use in the respiratory tract (ISO
8836:2007, corrected version 2008-03-15)
Sondes d'aspiration pour les voies respiratoires (ISO Absaugkatheter zur Verwendung im Atemtrakt (ISO
8836:2007, version corrigée 2008-03-15) 8836:2007, Korrigierte Fassung 2008-03-15)
This European Standard was approved by CEN on 28 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 8836:2009: E
worldwide for CEN national Members.
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SIST EN ISO 8836:2009
EN ISO 8836:2009 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 8836:2009
EN ISO 8836:2009 (E)
Foreword
The text of ISO 8836:2007 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 8836:2009 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 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 8836:2008.
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 8836:2007, corrected version 2008-03-15, has been approved by CEN as a EN ISO
8836:2009 without any modification.
3
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SIST EN ISO 8836:2009
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SIST EN ISO 8836:2009
INTERNATIONAL ISO
STANDARD 8836
Third edition
2007-09-01
Corrected version
2008-03-15
Suction catheters for use in the
respiratory tract
Sondes d'aspiration pour les voies respiratoires
Reference number
ISO 8836:2007(E)
©
ISO 2007
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SIST EN ISO 8836:2009
ISO 8836:2007(E)
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©
ii ISO 2007 – All rights reserved
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SIST EN ISO 8836:2009
ISO 8836:2007(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Size designation and dimension . 3
4.1 Size designation . 3
4.2 Dimension designation . 3
5 Materials . 4
6 Design . 4
6.1 Lumen . 4
6.2 Patient end . 4
6.3 Machine end . 4
7 Performance requirements . 6
7.1 Security of construction . 6
7.2 Shaft . 6
7.3 Vacuum control device . 6
8 Requirements for suction catheters supplied sterile . 6
8.1 Sterility assurance . 6
8.2 Packaging of suction catheters supplied sterile . 6
9 Marking . 6
9.1 Marking of suction catheters . 6
9.2 Use of symbols . 7
9.3 Labelling of individual packs . 7
9.4 Labelling of shelf/multi-unit packs . 7
Annex A (normative) Test methods . 8
Annex B (normative) Measurement of residual vacuum . 9
Bibliography . 11
©
ISO 2007 – All rights reserved iii
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SIST EN ISO 8836:2009
ISO 8836:2007(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 committees. 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 liaison 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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO8836 was prepared by Technical Committee ISO/TC121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Tracheal tubes and other equipment.
This third edition cancels and replaces the second edition (ISO 8836:1997) certain clauses of which have been
technically revised. Suction catheters are now required to have more than one orifice, except when used in low
vacuum systems or under direct vision. Material characteristics and requirements related to suction catheters
were previously informative but are now normative to comply with the Essential Requirements of the Medical
Device Directives. They have been moved from an informative annex to normative requirements in the body of
the standard. Table 1 (colour identification) has been combined with Table 2 (metric dimensions).
This corrected version of ISO 8836 contains changes to the Normative references on page 1.
ISO 11607 has been replaced by ISO 11607-1 and ISO 11607-2. The reference in subclause 8.2.2 on page 6
has been altered.
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SIST EN ISO 8836:2009
ISO 8836:2007(E)
Introduction
This International Standard specifies dimensions and requirements for suction catheters for use in the
respiratory tract.
Size is designated by outside diameter which is important when selecting catheters because of its relationship
to the ease with which the catheter can be passed through a tracheal or tracheostomy tube (see ISO 5361 for
details of requirements for tracheal tubes and tracheostomy tubes).
Flammability of suction catheters, for example if flammable anaesthetics, electrosurgical units or lasers are
1)
used, is a well-recognised hazard that is addressed by appropriate clinical management and is outside the
scope of this International Standard.
1) See ISO/TR 11991.
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SIST EN ISO 8836:2009
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vi
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SIST EN ISO 8836:2009
INTERNATIONAL STANDARD ISO 8836:2007(E)
Suction catheters for use in the respiratory tract
1Scope
This International Standard specifies requirements for suction catheters made of plastic materials and intended
for use in suction of the respiratory tract.
Specialized suction catheters, e.g. those with more than one lumen and suction catheters without a terminal
orifice, are excluded from the scope of this International Standard.
Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are not
considered to be specialized and are therefore included in the scope of this International Standard.
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.
ISO 10993-1, Biological evaluation of medical devices— Part1: Evaluation and testing within a risk
management system
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming,
sealing and assembly processes
EN 556-1:2001, Sterilization of medical devices— Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 1041, Information supplied by the manufacturer with medical devices
3 Terms and definitions
For the pu
...
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