EN ISO 8836:2014
(Main)Suction catheters for use in the respiratory tract (ISO 8836:2014)
Suction catheters for use in the respiratory tract (ISO 8836:2014)
ISO 8836:2014 specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.
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 ISO 8836:2014.
Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2014)
Diese Internationale Norm legt Anforderungen an Absaugkatheter aus flexiblen Materialien, einschließlich
geschlossene Absaugkatheter, zur Verwendung bei der Absaugung im Atemtrakt fest.
Absaugkatheter mit abgewinkelter Spitze (z. B. Coudé-Katheter) und Absaugkatheter mit Aspirator-
Sammlern werden nicht als Spezial-Absaugkatheter betrachtet und gehören deshalb zum
Anwendungsbereich dieser Internationalen Norm.
Absaugkatheter zur Verwendung mit brennbaren Anästhesiegasen oder Anästhesiemitteln, mit Lasern oder
elektrochirurgischen Geräten sind nicht Gegenstand dieser Internationalen Norm.
ANMERKUNG ISO/TR 11991 enthält einen Leitfaden zur Sicherung der Luftwege bei Laseranwendung in den oberen
Atemwegen.[6]
Sondes d'aspiration pour les voies respiratoires (ISO 8836:2014)
L'ISO 8836:2014 spécifie les exigences applicables aux sondes d'aspiration, notamment les sondes d'aspiration fermées, constituées de matériaux souples et destinées à une utilisation dans l'aspiration des voies respiratoires.
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 8836:2014.
Aspiracijski katetri za čiščenje dihalnih poti (ISO 8836:2014)
Ta mednarodni standard določa zahteve za aspiracijske katetre, vključno z zaprtimi aspiracijskimi katetri, izdelane iz prožnih materialov in namenjene čiščenju dihalnih poti. Aspiracijski katetri s poševno konico (npr. ukrivljeni katetri) in aspiracijski katetri z zbiralniki aspiratorjev se ne štejejo za specializirane, zato so vključeni v področje uporabe tega mednarodnega standarda. Aspiracijski katetri, namenjeni uporabi z vnetljivimi anestezijskimi plini ali sredstvi, laserji ali elektrokirurško
opremo, niso obravnavani v tem mednarodnem standardu.
OPOMBA: Glej standard ISO/TR 11991 za navodila za oskrbo dihal med lasersko operacijo zgornjih dihal.[6]
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2015
1DGRPHãþD
SIST EN ISO 8836:2009
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Suction catheters for use in the respiratory tract (ISO 8836:2014)
Absaugkatheter zur Verwendung im Atemtrakt (ISO 8836:2014)
Sondes d'aspiration pour les voies respiratoires (ISO 8836:2014)
Ta slovenski standard je istoveten z: EN ISO 8836:2014
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 8836
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.25; 11.040.10 Supersedes EN ISO 8836:2009
English Version
Suction catheters for use in the respiratory tract (ISO 8836:2014)
Sondes d'aspiration pour les voies respiratoires (ISO Absaugkatheter zur Verwendung im Atemtrakt (ISO
8836:2014) 8836:2014)
This European Standard was approved by CEN on 25 July 2014.
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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8836:2014 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 8836:2014) 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 2015, and conflicting national standards shall be withdrawn at the
latest by April 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 supersedes EN ISO 8836:2009.
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, 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 8836:2014 has been approved by CEN as EN ISO 8836:2014 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 one 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 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 and associated EFTA regulations.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential Requirements
Clause(s)/subclause (ERs) of Directive
Qualifying remarks/notes
(s) of this EN 93/42/EEC amended by
2007/47/EC
4, 7.1 (second, and third In the EU, competent authorities always require
indents) applicable ERs
6.1, 7.2 6.1 mandates that these devices shall satisfy the
biological safety testing indicated in ISO 10993-1.
9.1,
9.1 and 9.2 covers the integrity of the packaging
9.2
only for devices supplied sterile
4.1.1, 7.3 first sentence 4.1.1, 4.1.2, and 6 mandates a risk assessment
be carried out which does not exclude risks
4.1.2,
associated with materials and the substances with
which they may come into contact.
6.8, 7.5 Partly addressed by 6.8 and 10.3.2 i) calls
specifically for a warning if phthalates are
10.3.2 i)
incorporated
9.1, 8.1 9.1 and 10.3.2 f) and 10.4.2 g) mandate that
sterile devices are clearly marked according to
9.2,
EN 556–1 mandates the requirements of
10.3.2 f)
ISO 11607-1 to ensure that the packaging is
10.4.2 g)
suitable to prevent contamination during
transportation and use.
9.2 8.3 Partly addressed by 9.2 which mandates the
requirements of ISO 11607-1 that the packaging
is suitable to prevent contamination during
transportation and use.
9.1 8.4 9.1 mandates that sterile devices satisfy 4.1 of
EN 556–1
9.1 8.5 9.1 mandates that sterile devices satisfy 4.1 of
EN 556–1
10.3.2 f) 8.7 Partly covered. Marked sterile if appropriate
10.4.2 g)
7.3 9.1 Generally covered by mandating construction and
testing of interface connectors, and leakage and
7.4.1
resistance when attached to breathing systems.
7.4.2
7.4.6
8.1
8.4
8.5
5.1 9.2 (first three requirements) Partly covered to address only the risk of injury in
connection with their physical features by
5.2
specifying sizing and marking conventions for the
7.1
ID/OD and length of the catheter, design and
7.2
construction of the tip, additional protections if
provided by components of a closed suction
7.4.1
catheter, security of construction, performance of
7.4.3
the catheter shaft and vacuum control device, and
7.4.4
radiopacity.
7.4.5
8.1
8.2
8.3
8.6
10.1.3 10.1 (first sentence) Partly covered to address indication of tip angle,
length measurement and marking in cm and
10.1.4
colour codes for length marks, if provided. Limits
10.1.5
of accuracy are specified in the standard and not
10.1.6
disclosed by the manufacturer.
10.1.3 10.2 Tip direction and length mark positions are
mandated to provide ergonomic visibility during
10.1.4
intubation.
10.1.5
10.1.6
10.1.4 10.3 Length marking is mandated using SI units (mm).
Additional use of (cm) is permitted.
10.1.5
7.4.2.1 12.7.4 Suction catheter gas connectors are mandated to
comply with ISO 5356-1 for 15 mm and 22 mm
7.4.2.2
connectors.
7.4.5
Suction catheter flushing system connectors are
mandated to comply with ISO 594-1 or ISO 594-2
for Luers.
10 13.1 Covered by mandating marking and labelling and
instructions on the suction catheter, connector,
Annex A, Clause 4
unit label, shelf/multi-unit label and instructions for
use.
Annex A, Clause 4 draws attention to
consideration of disclosure of specific labelling
and instructions for intended use that may deviate
from the currently accepted medical practice.
10.2 13.2 Symbols are mandated in 10.2 to conform to
EN 1041, ISO 7000 or ISO 15223-1 and
ISO 15223-2
10.3.2 c) 13.3 a) Manufacturer identification mandated on the
device and on individual pack or any insert.
10.4.2 c)
Authorized representative mandated on the
individual pack or any insert.
10.3.2 13.3 b)
10.4.2
10.3.2 f) 13.3 c)
10.4.2 g)
10.4.2 d) 13.3 d) Batch code preceded by the word “LOT”
mandated for EU countries.
10.4.2 e) 13.3 e) 'Use by date' is partly addressed 'where
appropriate' as 'an indication of the date by which
the catheter should be used'. The EU regulation
makes it mandatory.
10.4.2 g) 13.3 f)
10.4.2 i)
Annex A, Clause 4 13.3 j) Annex A, Clause 4 draws attention to
consideration of disclosure of specific labelling
and instructions for intended use that may deviate
from the currently accepted medical practice.
10.3.2 f) 13.3 m)
10.4.2 g)
10.3 13.6, a), b), c) Instructions are limited to the mandated
information on labelling of individual packs, and
10.4 f)
preparation for use instructions on the shelf/multi-
pack label only.
10.4.2 h) 13.6 h) Limited to mandated instructions for cleaning,
disinfection, and resterilization on the shelf/multi-
pack label only. 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
10.4.2 f) 13.6 i) Limited to mandated instructions for preparation
for use on the shelf/multi-pack label only.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard
INTERNATIONAL ISO
STANDARD 8836
Fourth edition
2014-10-15
Suction catheters for use in the
respiratory tract
Sondes d’aspiration pour les voies respiratoires
Reference number
ISO 8836:2014(E)
©
ISO 2014
ISO 8836:2014(E)
© ISO 2014
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ISO 8836:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 *General requirements for open and closed suction catheters . 5
4.1 Risk management . 5
4.2 Safety . 6
5 Specific requirements for open and closed suction catheters . 6
5.1 Size and length designations. 6
5.2 *Dimensions . 6
6 Materials . 7
7 *Design .
...
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