SIST EN ISO 20697:2018
(Main)Sterile drainage catheters and accessory devices for single use (ISO 20697:2018)
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018)
This standard specifies requirements for sterile,single use drainage catheters, wound drainage systems and components thereof designed for drainage of fluids tothe exterior by means of gravity or negative pressure. This E. S. does not applyto: -catheters of less than 2 mm outside diameter;-suction catheters for use in the respiratory tract (see prEN 1733);-tracheal catheters (tracheal tubes) (see prEN 1782). NOTE: Urinary tract catheters are covered in prEN 1616.
Sterile Drainagekatheter und Zubehör zur einmaligen Verwendung (ISO 20697:2018)
Dieses Dokument legt die Anforderungen an sterile Drainagekatheter zur einmaligen Verwendung,
Drainagesysteme für Ansammlungen von Wund- und Körperflüssigkeiten sowie chirurgische Drainagekatheter
und deren Bestandteile fest, wo der Katheter durch chirurgischen Eingriff oder perkutane Punktion
in einer Körperhöhle oder einer Wunde platziert wird, um Flüssigkeit oder Luft nach außen abzuleiten.
Die Ableitung über den Drainagekatheter erfolgt auf natürlichem Wege oder der Katheter wird mit einer
Absaugvorrichtung verbunden, um die schnellere Bildung von Granulationsgewebe zu ermöglichen.
Dieses Dokument ist nicht anwendbar für:
a) Absaugkatheter;
b) Trachealkatheter;
c) Harnblasenkatheter;
ANMERKUNG Siehe ISO 20696.
d) Ureterstents, Gallenstents und andere Stents;
ANMERKUNG Die Anforderungen an Stents sind in ISO 14630 und ASTM F1828-97 festgelegt.
e) Drainagekatheter, die perkutan mittels Gastrostomie im Verdauungstrakt platziert werden;
f) Rückenmarkskatheter zur Entnahme von Rückenmarksflüssigkeit;
ANMERKUNG Siehe ISO 20698.
g) Darmkatheter zur Entfernung von Lösungen oder Substanzen aus dem Magen-Darm-Trakt (Gastrointestinaltrakt);
ANMERKUNG Siehe ISO 20695.
h) Beschichtungen.
Sondes et dispositifs auxiliaires stériles de drainage non réutilisables (ISO 20697:2018)
Le présent document spécifie les exigences applicables aux sondes de drainage stériles non réutilisables, aux systèmes de drainage de plaie et de collection liquidienne, aux sondes de drainage chirurgicales ainsi qu'à leurs éléments constitutifs; la sonde étant placée dans une cavité corporelle ou dans une plaie, par voie chirurgicale ou percutanée, afin d'évacuer le liquide ou l'air vers l'extérieur.
La sonde de drainage est disposée de sorte que le liquide ou l'air s'écoule librement, mais elle peut également être raccordée à une source d'aspiration pour accélérer la granulation des tissus.
Le présent document ne s'applique pas:
a) aux sondes d'aspiration;
b) aux sondes endotrachéales;
c) aux sondes urinaires;
NOTE Voir l'ISO 20696.
d) aux endoprothèses urétérales, endoprothèses biliaires et autres endoprothèses;
NOTE Voir l'ISO 14630 et l'ASTM F1828‑97 pour les exigences applicables aux endoprothèses.
e) aux sondes de drainage percutanées posées par gastrostomie dans les voies digestives;
f) aux sondes neuraxiales utilisées pour l'évacuation du liquide céphalorachidien;
NOTE Voir l'ISO 20698.
g) aux sondes entérales utilisées pour l'évacuation de solutions ou de substances dans les voies gastro-intestinales;
NOTE Voir l'ISO 20695.
h) aux revêtements.
Sterilni drenažni katetri in dodatni pripomočki za enkratno uporabo (ISO 20697:2018)
Ta standard določa zahteve za sterilne drenažne katetre za enkratno uporabo, sisteme za drenažo ran in njihove komponente, zasnovane za drenažo tekočin iz notranjosti s pomočjo težnosti ali negativnega tlaka. Ta evropski standard se ne uporablja za: - katetre z zunanjim premerom, manjšim od 2 mm; - aspiracijske katetre za uporabo v dihalnem traktu (glej prEN 1733); - trahealne katetre (trahealne cevke) (glej prEN 1782). OPOMBA: Urinski katetri so zajeti v standardu prEN 1616.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20697:2018
01-september-2018
1DGRPHãþD
SIST EN 1617:2000
6WHULOQLGUHQDåQLNDWHWULLQGRGDWQLSULSRPRþNL]DHQNUDWQRXSRUDER ,62
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018)
Sterile Drainagekatheter und Zubehör zur einmaligen Verwendung (ISO 20697:2018)
Sondes et dispositifs auxiliaires stériles de drainage non réutilisables (ISO 20697:2018)
Ta slovenski standard je istoveten z: EN ISO 20697:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 20697:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20697:2018
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SIST EN ISO 20697:2018
EN ISO 20697
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN 1617:1997
English Version
Sterile drainage catheters and accessory devices for single
use (ISO 20697:2018)
Sondes et dispositifs auxiliaires stériles de drainage Sterile Drainagekatheter und Zubehör zur einmaligen
non réutilisables (ISO 20697:2018) Verwendung (ISO 20697:2018)
This European Standard was approved by CEN on 3 May 2018.
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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20697:2018 E
worldwide for CEN national Members.
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SIST EN ISO 20697:2018
EN ISO 20697:2018 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 20697:2018
EN ISO 20697:2018 (E)
European foreword
This document (EN ISO 20697:2018) has been prepared by Technical Committee ISO/TC 84 " Devices
for administration of medicinal products and catheters " in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
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 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1617:1997.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20697:2018 has been approved by CEN as EN ISO 20697:2018 without any modification.
3
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SIST EN ISO 20697:2018
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SIST EN ISO 20697:2018
INTERNATIONAL ISO
STANDARD 20697
First edition
2018-06
Sterile drainage catheters and
accessory devices for single use
Sondes et dispositifs auxiliaires stériles de drainage non réutilisables
Reference number
ISO 20697:2018(E)
©
ISO 2018
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 3
5 General requirements . 3
5.1 Risk management . 3
5.2 Biocompatibility . 4
5.3 Detectability . 4
5.4 Surface finish . 4
5.5 Size designation . 4
5.5.1 General. 4
5.5.2 Outer diameter . 4
5.5.3 Effective length . 4
5.5.4 Nominal balloon inflation volume . 5
5.6 Connector . 5
5.7 MRI compatibility . 6
5.8 Sterilization . 6
6 Specific requirements . 6
6.1 Kink stability . 6
6.2 Corrosion resistance . 6
6.3 Resistance to deformation . 6
6.4 Peak tensile force . 6
6.4.1 Connections . 6
6.4.2 Drainage catheters and other accessory devices . 7
6.5 Impact resistance . 7
6.6 Flow rate . 7
6.7 Retention strength . 7
6.8 Balloon safety . 7
6.9 Catheter inflation lumen integrity and volume maintenance . 8
6.9.1 General. 8
6.9.2 Compliant balloon. 8
6.9.3 Non-compliant balloon . 8
6.10 Inflated balloon resistance to traction . . 8
6.11 Freedom from leakage during aspiration or vacuum . 8
7 Information supplied by the manufacturer . 9
7.1 General . 9
7.2 Marking on the device and/or packaging . 9
7.3 Instructions for use . 9
Annex A (informative) Test method for determining kink stability .11
Annex B (normative) Test method for corrosion resistance .13
Annex C (normative) Test method for resistance to deformation by suction .14
Annex D (normative) Test method for determining peak tensile force of connections .15
Annex E (normative) Test method for determining peak tensile force of drainage catheter .16
Annex F (normative) Test method for impact resistance of collection device .18
Annex G (normative) Test method for determination of flow rate through catheter .20
Annex H (informative) Test method for retention strength .22
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
Annex I (normative) Test method for determining balloon safety .24
Annex J (normative) Test method for determining inflation lumen leakage and/or function
and/or balloon deflation (catheter with compliant balloon) .27
Annex K (normative) Test method for determining balloon size and deflation reliability
(catheter with non-compliant balloon) .29
Annex L (normative) Test method for determining inflated balloon resistance to traction .31
Annex M (normative) Test method for resistance to leakage during aspiration or vacuum .35
Bibliography .37
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SIST EN ISO 20697:2018
ISO 20697:2018(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 (see 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 (see 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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
This document is based on EN 1617, Sterile drainage catheters for single use.
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
Introduction
Guidance on transition periods for implementing the requirements of this document is given in ISO/
TR 19244.
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SIST EN ISO 20697:2018
INTERNATIONAL STANDARD ISO 20697:2018(E)
Sterile drainage catheters and accessory devices for
single use
1 Scope
This document specifies requirements for sterile, single use drainage catheters, wound and fluid
accumulation drainage systems, surgical drainage catheters and their components, where the catheter
is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the
exterior.
The drainage catheter is left to drain naturally or connected to a suction source for faster tissue
granulation.
This document is not applicable to:
a) suction catheters;
b) tracheal catheters;
c) urethral catheters;
NOTE See ISO 20696.
d) ureteral stents, biliary stents, and other stents;
NOTE See ISO 14630 and ASTM F1828-97 for stents requirements.
e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;
f) neuraxial catheters used for removal of cerebrospinal fluid;
NOTE See ISO 20698.
g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract;
NOTE See ISO 20695.
h) coatings.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 — Part 1: Evaluation and testing within a risk
management process
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 80369-1, Small bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at https: //www .electropedia .org/
3.1
accessory device
device that is used with the drainage system (3.6) for access and/or drainage [e.g. collection device(s)
(3.3)] and, where applicable, other accessories such as suction source(s) (3.16), connecting tube(s) (3.4),
connector(s), trocar(s), split needle(s)/cannula(s), or introducer(s)
3.2
catheter component
part which is integral with the drainage catheter
EXAMPLE Catheter connectors, securement devices, Heimlich valve.
3.3
collection device
bag, bellows or other portable container designed for collecting liquid
3.4
connecting tube
tube designed for connecting the drainage catheter and collection device (3.3), or collection device (3.3)
and suction source (3.15)
3.5
drainage catheter
tube designed for draining fluid or air from a body cavity or a surgical wound
3.6
drainage system
functional assembly of drainage catheter (3.5) and collection device(s) (3.3) and, where applicable, other
accessories such as suction source(s) (3.16), connecting tube(s) (3.4), connector(s) or trocar(s)
Note 1 to entry: A drainage system may be supplied either in the ready-for-use state or in a state requiring the
assembly of some components by the user. Drainage may be achieved either by gravity, by negative pressure
generated by an external power source, by manipulation by the user, or by the pre-evacuation of the collection
device (3.3).
3.7
effective length
L
1
length of the catheter, or pre- and post-hydration lengths of hydratable catheters, that can be inserted
into the body
3.8
overall length
L
2
total length from the tip of the catheter to the end of the funnel (3.10)
3.9
effective shaft length
L
3
length of non-perforated portion of the catheter excluding the tip, balloon(s), funnel(s) (3.10), protective
sleeves and/or access port(s)
3.10
funnel
proximal portion of the catheter, which may be connected to a drainage system (3.7)
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
3.11
retention means
physical feature of the catheter within the body that prevents movement of the catheter out of the body
EXAMPLE Pigtail, suture with pigtail, malecot, balloon.
3.12
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2007, 2.16]
3.13
risk analysis
systematic use of available information to identify hazards and to estimate the risk (3.12)
[SOURCE: ISO 14971:2007, 2.17]
Note 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous
situations and harm (see Annex E of ISO 14971:2007).
3.14
risk assessment
overall process comprising a risk analysis (3.12) and a risk evaluation
[SOURCE: ISO 14971:2007, 2.18]
3.15
risk management file
set of records and other documents that are produced by risk management
[SOURCE: ISO 14971:2007, 2.23]
3.16
suction source
self-contained device capable of exerting a negative pressure on a drainage catheter (3.5) or system
Note 1 to entry: The suction source may be the collection device (3.3).
3.17
trocar
needle, pointed rod sleeve or any combination thereof which assists in passing the drainage catheter
(3.5) through the body wall
4 Intended performance
The drainage catheter shall demonstrate the ability to accurately and safely access the intended
location. The drainage system shall demonstrate the ability to maintain drainage.
If the drainage catheter has retention means, it shall demonstrate the ability to prevent undesired
dislodgement. The method of release of retention shall be described in the instructions for use.
5 General requirements
5.1 Risk management
An established risk management process shall be applied to the design of the device and a risk analysis
shall be performed.
EXAMPLE ISO 14971.
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
Compliance shall be checked by inspection of the risk management file. If clinical studies are performed,
these studies shall document measurements taken under conditions for which performance is claimed.
The clinical studies shall comply with the requirements of ISO 14155.
5.2 Biocompatibility
The device shall be free from biological hazard in accordance with appropriate testing under
ISO 10993-1.
5.3 Detectability
The catheter or at least its effective length shall be detectable by X-ray or by other means (ultra-sound,
MRI, etc.), if required by the risk assessment.
NOTE Such as ASTM F640 or DIN 13273-7.
5.4 Surface finish
When examined by normal or corrected to normal vision, the external surface of the effective length of
the catheter shall appear free from:
— extraneous matter;
— process and surface defects that may present an unacceptable risk of patient harm.
If deemed necessary based on risk assessment, inspection shall be conducted under a minimum 2,5×
magnification.
5.5 Size designation
5.5.1 General
The nominal size of the catheter shall be designated as specified in 5.5.2, 5.5.3 and 5.5.4. Examples of
drainage catheters are shown in Figure 1.
5.5.2 Outer diameter
Unless otherwise specified in another part of this document for a particular type of catheter, the outer
diameter shall be expressed as the nominal dimension in millimetres, rounded upwards to the nearest
0,1 mm. Tolerances on this stated size shall be ±1 French.
For devices which are not round by design, the size shall be designated by the dimension of the largest
axis. Where relevant, manufacturers may choose to report additional information regarding the device
profile, such as the dimension of the second axis for an oval shape.
NOTE French size (Fr, CH) is a nominal dimensional identification of the outer size of drainage catheters;
calculated as three times the diameter (in millimetres): Fr = 3 × D (mm).
5.5.3 Effective length
The effective length shall be expressed in millimetres for effective lengths of less than 100 mm, or
either in millimetres or centimetres for effective lengths of 100 mm or more.
NOTE This document does not specify tolerances on the effective length.
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SIST EN ISO 20697:2018
ISO 20697:2018(E)
Key
1 funnel L effective length
1
2 lateral drainage holes L overall length
2
3 inflation connection L effective shaft length
3
4 retention means
Figure 1 — Examples of drainage catheters
5.5.4 Nominal balloon inflation volume
For devices which have balloons, the nominal balloon inflation volume shall be expressed in millilitres.
5.6 Connector
This document does not specify a standard connector for inclusion in drainage catheters and accessory
devices. However, risk of misconnection shall be avoided. This shall be determined by the manufacturer
based on risk assessment according to the general requirements of ISO 80369-1.
NOTE The funnel is a connecting part, but does not comply with the requirements of ISO 80369-1.
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ISO 20697:2018(E)
5.7 MRI compatibility
If applicable, the hazards of drainage catheters and accessory devices in the magnetic resonance
environment shall be evaluated by an appropriate method.
NOTE Such as ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119.
5.8 Sterilization
Drainage catheters and accessories that are sterile shall comply with international, national or regional
−6
standards and shall have a sterility assurance level (SAL) of 10 .
NOTE See applicable parts of ISO 17665, ISO 11135 and ISO 11137 (all parts) for appropriate methods of
sterilization.
6 Specific requirements
6.1 Kink stability
During placement, the drainage catheter shall demonstrate the ability to safely access the intended
location. This document does not specify requirements for kink stability testing. Clinically relevant
placement value is determined by the manufacturer based on intended use and risk assessment.
NOTE A kink stability test method is shown in Annex A.
6.2 Corrosion resistance
If exposed metallic components of the device could develop visible signs of corrosion that can affect
functional performance, the level of corrosion shall be evaluated, with respect to intended use and risk
assessment, by subjecting the catheter to the corrosion test described in Annex B.
6.3 Resistance to deformation
The drainage catheter, accessory devices, or any component(s) designed to form a part thereof,
intended to operate under negative pressure shall not show deformation (collapse) sufficient to impair
the function of the device at the maximum negative pressure as defined by the manufacturer.
Compliance shall be checked according to test method in Annex C.
6.4 Peak tensile force
6.4.1 Connections
The minimum peak tensile force of the external connections between devices recommended by the
manufacturer shall be as given in Table 1.
Table 1 — Peak tensile force of
...
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