SIST EN ISO 20696:2018
(Main)Sterile urethral catheters for single use (ISO 20696:2018)
Sterile urethral catheters for single use (ISO 20696:2018)
This standard specifies requirements for sterile, single-use urethral catheters, with and without balloons.
Sterile Harnblasenkatheter zur einmaligen Verwendung (ISO 20696:2018)
Dieses Dokument legt Anforderungen und Prüfverfahren für sterile Harnblasenkatheter mit und ohne Ballon
zur einmaligen Verwendung fest.
Dieses Dokument schließt nicht Drainagekatheter mit ein, die in ISO 20697 behandelt werden, z. B.
Ureterkatheter, Nephrostomiekatheter und suprapubische Katheter. Des Weiteren sind auch Ureterstents
von diesem Dokument ausgeschlossen.
ANMERKUNG Ureterstents sind Gegenstand der Norm ASTM F1828-97.
Sondes urinaires stériles non réutilisables (ISO 20696:2018)
Le présent document spécifie les exigences et les méthodes d'essai pour les sondes urinaires stériles non réutilisables, avec ou sans ballonnet.
Le présent document n'inclut pas les sondes de drainage couvertes par l'ISO 20697, telles que les sondes urinaires, les sondes de néphrostomie et les cathéters sus-pubiens. Le présent document exclut également les endoprothèses urétérales.
NOTE Les endoprothèses urétérales sont couvertes par l'ASTM F1828‑97.
Sterilni uretralni katetri za enkratno uporabo (ISO 20696:2018)
Ta standard določa zahteve za sterilne uretralne katetre za enkratno uporabo z balonom ali brez.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20696:2018
01-september-2018
1DGRPHãþD
SIST EN 1616:2000
SIST EN 1616:2000/A1:2000
Sterilni uretralni katetri za enkratno uporabo (ISO 20696:2018)
Sterile urethral catheters for single use (ISO 20696:2018)
Sterile Harnblasenkatheter zur einmaligen Verwendung (ISO 20696:2018)
Sondes urinaires stériles non réutilisables (ISO 20696:2018)
Ta slovenski standard je istoveten z: EN ISO 20696:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 20696:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20696:2018
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SIST EN ISO 20696:2018
EN ISO 20696
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN 1616:1997
English Version
Sterile urethral catheters for single use (ISO 20696:2018)
Sondes urinaires stériles non réutilisables (ISO Sterile Harnblasenkatheter zur einmaligen
20696:2018) Verwendung (ISO 20696:2018)
This European Standard was approved by CEN on 5 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 20696:2018 E
worldwide for CEN national Members.
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SIST EN ISO 20696:2018
EN ISO 20696:2018 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 20696:2018
EN ISO 20696:2018 (E)
European foreword
This document (EN ISO 20696:2018) 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 1616:1997.
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 20696:2018 has been approved by CEN as EN ISO 20696:2018 without any modification.
3
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SIST EN ISO 20696:2018
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SIST EN ISO 20696:2018
INTERNATIONAL ISO
STANDARD 20696
First edition
2018-06
Sterile urethral catheters for single use
Sondes urinaires stériles non réutilisables
Reference number
ISO 20696:2018(E)
©
ISO 2018
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SIST EN ISO 20696:2018
ISO 20696:2018(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
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 20696:2018
ISO 20696:2018(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 . 3
5.3 Detectability . 3
5.4 Surface finish . 3
5.5 Size designation . 3
5.5.1 General. 3
5.5.2 Outer diameter . 3
5.5.3 Effective shaft lengths . 4
5.6 MRI compatibility . 5
5.7 Connector . 5
5.8 Sterilization . 5
6 Specific requirements . 5
6.1 Strength . 5
6.2 Connector security . . 5
6.3 Balloon safety . 5
6.4 Catheter inflation lumen integrity and volume maintenance . 5
6.4.1 General. 5
6.4.2 Compliant balloon. 6
6.4.3 Non-compliant balloon . 6
6.5 Flow rate . 6
6.6 Corrosion resistance . 7
6.7 Kink stability . 7
6.8 Peak tensile force . 7
6.9 Inflated balloon resistance to traction . . 7
7 Information to be supplied by the manufacturer . 8
7.1 General . 8
7.2 Marking on the device and/or packaging . 8
7.3 Instructions for use . 8
Annex A (normative) Test method for determining the strength of the catheter .10
Annex B (normative) Test method for determining the security of fit of the drainage funnel .14
Annex C (normative) Test method for determining balloon safety .16
Annex D (normative) Test method for determining inflation lumen leakage and/or function
and/or balloon deflation (catheter with compliant balloon) .19
Annex E (normative) Test method for determination of flow rate through catheter .21
Annex F (normative) Test method for corrosion resistance .23
Annex G (informative) Test method for determining kink stability .24
Annex H (normative) Test method for determining peak tensile force of urethral catheter .26
Annex I (normative) Test method for determining balloon size deflation reliability
(catheter with non-compliant balloon) .28
Annex J (normative) Test method for determining inflated balloon resistance to traction .30
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
Bibliography .34
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SIST EN ISO 20696:2018
ISO 20696:2018(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 1616, Sterile urethral catheters for single use.
© ISO 2018 – All rights reserved v
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
Introduction
Guidance on transition periods for implementing the requirements of this document is given in ISO/
TR 19244.
vi © ISO 2018 – All rights reserved
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SIST EN ISO 20696:2018
INTERNATIONAL STANDARD ISO 20696:2018(E)
Sterile urethral catheters for single use
1 Scope
This document specifies requirements and test methods for sterile urethral catheters for single use,
with or without a balloon.
This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters,
nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.
NOTE Ureteral stents are covered in ASTM F1828-97.
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 14971, Medical devices — Application of risk management to medical devices
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
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.
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
balloon capacity
volume of liquid to be introduced into the catheter in order to fill the inflation channel and inflate
the balloon
3.2
coating
substance applied to the surface of the catheter
3.3
compliant balloon
balloon that continues to expand in size as internal pressure increases
3.4
effective length
L
1
length of the catheter that can be inserted into the body
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
3.5
effective shaft length
L
3
length of non-perforated portion of the catheter excluding the tip, balloon(s), funnel(s) (3.6), protective
sleeves and/or access port(s)
3.6
funnel
proximal portion of the catheter, which may be connected to a drainage system
Note 1 to entry: See Figures J.1 and J.2.
3.7
intermittent
intended to be removed immediately after emptying the bladder
3.8
non-compliant balloon
balloon that expands to one specific size or size range, even as internal pressure increases
3.9
outer diameter
maximum dimension measured across the cylindrical portion of the shaft
3.10
overall length
L
2
total length from the tip of the catheter to the end of the funnel (3.6)
3.11
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2007, 2.16]
3.12
risk analysis
systematic use of available information to identify hazards and to estimate the risk (3.11)
Note 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous
situations and harm (see ISO 14971:2007, Annex E).
[SOURCE: ISO 14971:2007, 2.17]
3.13
risk assessment
overall process comprising a risk analysis (3.12) and a risk evaluation
[SOURCE: ISO 14971:2007, 2.18]
3.14
risk management file
set of records and other documents that are produced by risk management
[SOURCE: ISO 14971:2007, 2.23]
3.15
urethral catheter
tubular device intended for being introduced into the urinary bladder through the urethra in order to
provide drainage, drug delivery and/or flushing of the bladder
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
4 Intended performance
The urethral catheter shall demonstrate the ability to accurately and safely access the intended location.
The urethral catheter shall demonstrate the ability to drain urine.
5 General requirements
5.1 Risk management
An established risk management process shall be applied to the design of the device.
Compliance shall be checked by inspection of the risk management file verifying compliance to
ISO 14971.
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.
5.5.2 Outer diameter
Unless otherwise specified in another clause 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 ±0,33 mm.
NOTE Additional units can also be given. French size (Fr, Ch, FG) is a nominal dimensional identification of
the outer size of drainage catheters; calculated as three times the diameter (in millimetres): Fr = 3 × D (mm).
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.
The balloon capacity shall be expressed in millilitres.
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
5.5.3 Effective shaft lengths
The minimum effective shaft lengths (L ) shall be as given in Table 1 (see also Figure 1).
3
The nominal effective shaft length (L ) shall be expressed in millimetres, rounded to the nearest
3
millimetre.
NOTE 1 Additional units can also be given.
NOTE 2 Tolerances to the effective length are not specified.
Table 1 — Effective shaft length
Catheter type L (minimum) mm
3
Paediatric male 150
Paediatric female 45
Female 60
Male 275
NOTE Shaft dimensions: Shorter sizes can be produced using appropriate risk based clinical justification.
Key
1 drainage funnel L effective length
1
2 inflation access port L overall length
2
3 valve L effective shaft length
3
4 irrigation access port
Figure 1 — Typical urethral catheters with and without balloon
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
5.6 MRI compatibility
If applicable, the hazards of urethral catheters in the magnetic resonance environment shall be
evaluated by an appropriate method.
NOTE Such as ASTM F2052, F2213, F2182, and F2119.
5.7 Connector
There is no standardized connector. 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 1 A future part of ISO 80369 will address connectors for urethral and urinary applications.
NOTE 2 The funnel is a connecting part, but does not comply with the requirements of ISO 80369-1.
5.8 Sterilization
Urethral 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 Strength
When tested the tip/shaft union and lateral drainage holes shall not show any sign of breaking and
neither the tip nor the funnel shall become detached from the shaft.
Compliance shall be checked by the test method in Annex A.
6.2 Connector security
When tested the drainage funnel shall not part from the test connector.
Compliance shall be checked by the test method in Annex B.
6.3 Balloon safety
If present, the balloon shall not leak and shall not occlude the lateral drainage holes.
Compliance shall be checked by the test method in Annex C.
The change in profile at each end of the uninflated balloon should have a smooth transition to the shaft.
The balloon should be capable of approximately symmetrical expansion when filled with water at
ambient temperature to its specified balloon capacity.
6.4 Catheter inflation lumen integrity and volume maintenance
6.4.1 General
If a balloon is present, choose the appropriate requirement from 6.4.2 and 6.4.3.
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
6.4.2 Compliant balloon
When deflating the balloon, the percentage of water recovered shall not be lower than the value given
in Table 2.
Table 2 — Balloon test volume percentage recovery
Balloon capacity Minimum percentage of volume recovered
ml %
5 55
10 75
20 80
30 80
This document does not specify requirements for balloon capacity of less than 5 ml. These values should be
determined by the manufacturer based on risk assessment.
Intermediate cases are recommended to comply with the next higher value.
Compliance shall be checked by using the test method in Annex D.
6.4.3 Non-compliant balloon
For 12 French to 30 French catheters, the balloon shall pass through a French size no greater than one
(1) French larger than the outer diameter of the uninflated balloon.
This document does not specify requirements for catheter sizes less than 12 French. These values
should be determined by the manufacturer based on risk assessment.
Compliance shall be checked by using the test method in Annex I.
6.5 Flow rate
The minimum average flow rates shall be as given in Table 3.
Table 3 — Average flow rates
Designated size Average flow rate (minimum)
a
Outer diameter Charrière equivalent Drainage lumen Irrigation lumen
mm FG/Ch/Fr ml/min ml/min
b
2,0 6 10 n.a.
2,7 8 15 n.a.
3,3 10 30 n.a.
4,0 12 50 n.a.
4,7 14 70 25
5,3 16 100 25
6,0 18 100 25
6,7 20 100 25
7,3 22 100 30
8,0 24 100 30
NOTE The listed flow rate values are a minimum requirement; clinical flow rate values may be higher.
a
The Charrière equivalent is given for information.
b
n.a. = not applicable
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
Table 3 (continued)
Designated size Average flow rate (minimum)
a
Outer diameter Charrière equivalent Drainage lumen Irrigation lumen
mm FG/Ch/Fr ml/min ml/min
8,7 26 100 30
9,3 28 100 n.a.
10,0 30 100 n.a.
NOTE The listed flow rate values are a minimum requirement; clinical flow rate values may be higher.
a
The Charrière equivalent is given for information.
b
n.a. = not applicable
Compliance shall be checked using the flow rate test method in Annex E.
6.6 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 F.
6.7 Kink stability
During placement, the urethral 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 Such as kink stability test method in Annex G.
6.8 Peak tensile force
The minimum peak tensile force of the urethral catheter tubular portion, each junction between
catheter component and tubing, and each junction between tubular portions shall be as given in Table 4.
Table 4 — Peak tensile force of urethral catheters
Smallest outer diameter of tubular Minimum peak tensile force
portion of test piece
mm N
≥2 and ≤4 10
>4 20
This document does not specify requirements for peak tensile force for tubing of less than 2 mm outer
diameter. These values should be determined by the manufacturer based on risk assessment.
Compliance shall be checked using the test method in Annex H.
6.9 Inflated balloon resistance to traction
For catheter shafts 14 French and above, the balloon shall not pass into or through a funnel support
barrel greater than one (1) French larger than the outer diameter of the uninflated balloon.
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