SIST EN ISO 8836:2015
(Main)Suction catheters for use in the respiratory tract (ISO 8836:2014)
Suction catheters for use in the respiratory tract (ISO 8836:2014)
This International Standard 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 this International Standard.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this International Standard.
NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway.[6]
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
SIST EN ISO 8836:2015
01-januar-2015
1DGRPHãþD
SIST EN ISO 8836:2009
$VSLUDFLMVNLNDWHWUL]DþLãþHQMHGLKDOQLKSRWL ,62
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
SIST EN ISO 8836:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8836:2015
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SIST EN ISO 8836:2015
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.
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SIST EN ISO 8836:2015
EN ISO 8836:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 8836:2015
EN ISO 8836:2014 (E)
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.
3
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SIST EN ISO 8836:2015
EN ISO 8836:2014 (E)
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
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
6
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
4
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SIST EN ISO 8836:2015
EN ISO 8836:2014 (E)
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.
5
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SIST EN ISO 8836:2015
EN ISO 8836:2014 (E)
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
6
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SIST EN ISO 8836:2015
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
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SIST EN ISO 8836:2015
ISO 8836:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 8836:2015
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 . 8
7.1 Lumen of the suction catheter . 8
7.2 Suction catheter tip . 8
7.3 *Suction catheter connector . 8
7.4 Additional requirements for closed suction catheters .10
8 Performance requirements .12
8.1 Security of construction .12
8.2 Shaft performance .12
8.3 *Vacuum control device performance .13
8.4 *Leakage .13
8.5 *Resistance to flow .13
8.6 *Radiopacity .13
9 Requirements for suction catheters supplied sterile.13
9.1 Sterility assurance .13
9.2 Packaging of suction catheters supplied sterile .14
10 Marking .14
10.1 Marking on suction catheters .14
10.2 Use of symbols .15
10.3 Labelling of individual packs .16
10.4 Labelling of shelf/multi-unit packs .16
Annex A (informative) Rationale .18
Annex B (normative) Test method for security of attachment .21
Annex C (normative) Measurement of residual vacuum .22
Annex D (normative) Method of testing leakage .24
Annex E (informative) Hazard identification for risk assessment .25
Bibliography .27
© ISO 2014 – All rights reserved iii
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SIST EN ISO 8836:2015
ISO 8836:2014(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Airways and related equipment.
This fourth edition of ISO 8836 cancels and replaces the third edition (ISO 8836:2007), of which it
constitutes a technical revision.
iv © ISO 2014 – All rights reserved
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SIST EN ISO 8836:2015
ISO 8836:2014(E)
Introduction
This International Standard specifies dimensions and requirements for suction catheters for use in the
respiratory tract. It is concerned with the basic requirements and method of size designation of both
open and closed suction catheters made of flexible materials.
The method of describing tube dimensions and configuration has been devised in order to assist clinicians
in the selection of the most suitable suction catheter for a particular patient. Size is designated by
outside diameter which is important when selecting a catheter because of its relationship to the ease
[2][3][4]
with which the catheter can be passed through a tracheal or tracheostomy tube.
Revisions in this fourth edition are intended to harmonize this International Standard with recent
amendments in the European Medical Device Directive.
Major technical revisions in this edition include requirements for closed suction catheters, new
requirements to harmonize this International Standard with requirements for critical care ventilators,
and risk management.
[1]
Terms defined in Clause 3 of this International Standard or in ISO 4135 appear in bold type.
Throughout this International Standard, text for which a rationale is provided in Annex A is indicated
by an asterisk (*).
© ISO 2014 – All rights reserved v
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SIST EN ISO 8836:2015
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SIST EN ISO 8836:2015
INTERNATIONAL STANDARD ISO 8836:2014(E)
Suction catheters for use in the respiratory tract
1 Scope
This International Standard 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 this International Standard.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this International Standard.
[6]
NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable to its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
*ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment
— Part 1: General requirements
*ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
1)
ISO 5367:— , Anaesthetic and respiratory equipment — Breathing sets and connectors
2)
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 10079-1, Medical suction equipment — Part 1: Electrically powered suction equipment
ISO 10079-2, Medical suction equipment — Part 2: Manually powered suction equipment
ISO 10079-3, Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive
pressure gas source
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
1) To be published. (Revision of ISO 5367:2000)
2) The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more information, consult
http://www.iso.org/iso/publications_and_e-products/databases.htm?=.
© ISO 2014 – All rights reserved 1
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SIST EN ISO 8836:2015
ISO 8836:2014(E)
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information to
be supplied — Part 2: Symbol development, selection and validation
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
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 of medical devices
EN 15986, Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices
containing phthalates
ASTM D3002:2007, Standard Guide for Evaluation of Coatings Applied to Plastics
ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use
3 Terms and definitions
[1]
For the purposes of this document, the terms and definitions given in ISO 4135 and ISO 14971 and the
following apply.
3.1
adaptor
specialized connector to establish functional continuity between otherwise disparate or
incompatible components
[SOURCE: ISO 4135:2001, 4.2.3.1]
3.2
connector
fitting to join together two or more components
[SOURCE: ISO 4135:2001, 4.2.2.1]
3.3
*closed suction catheter
suction catheter enclosed within a protective sleeve and patient end adaptor that allows its use
within the airway without opening the breathing system directly to atmosphere
3.4
eye
side hole near the patient end of the suction catheter
[SOURCE: ISO 4135:2001, 8.3.6]
2 © ISO 2014 – All rights reserved
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SIST EN ISO 8836:2015
ISO 8836:2014(E)
3.5
machine end
that end of the catheter which is intended to be connected to a source of vacuum
[SOURCE: ISO 4135:2001, 8.3.2]
3.6
open suction catheter
suction catheter that is not enclosed within a protective sleeve and patient end adaptor or
attached to a VBS
3.7
patient connection port
opening at the patient end of a breathing system port of a ventilator
breathing system intended for connection to an airway device
[SOURCE: ISO 4135:2001, 4.2.1.2]
3.8
patient end
that end of the suction catheter which is intended to be inserted into a patient
[SOURCE: ISO 4135:2001, 8.3.3]
3.9
patient end
the patient connection port of the closed suction catheter patient end
adaptor intended to be connected to the conical connector of an artificial airway (e.g. tracheostomy or
tracheal tube)
3.10
*patient end adaptor
tubular connector with multiple ports, one of which is a patient connection port
3.11
protective sleeve
flexible barrier that encloses the suction catheter shaft to pr
...
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