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

Status
Published
Public Enquiry End Date
09-May-2017
Publication Date
23-Aug-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
16-Jul-2018
Due Date
20-Sep-2018
Completion Date
24-Aug-2018

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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

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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.

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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

© ISO 2018 – All rights reserved iii
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SIST EN ISO 20696:2018
ISO 20696:2018(E)

Bibliography .............................................................................................................................................................................................................................34

iv © ISO 2018 – All rights reserved
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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
length of the catheter that can be inserted into the body
© ISO 2018 – All rights reserved 1
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
3.5
effective shaft length

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
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
2 © ISO 2018 – All rights reserved
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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.
© ISO 2018 – All rights reserved 3
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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).

The nominal effective shaft length (L ) shall be expressed in millimetres, rounded to the nearest

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
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
2 inflation access port L overall length
3 valve L effective shaft length
4 irrigation access port
Figure 1 — Typical urethral catheters with and without balloon
4 © ISO 2018 – All rights reserved
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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

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.

© ISO 2018 – All rights reserved 5
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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)
Outer diameter Charrière equivalent Drainage lumen Irrigation lumen
mm FG/Ch/Fr ml/min ml/min
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.

The Charrière equivalent is given for information.
n.a. = not applicable
6 © ISO 2018 – All rights reserved
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SIST EN ISO 20696:2018
ISO 20696:2018(E)
Table 3 (continued)
Designated size Average flow rate (minimum)
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.

The Charrière equivalent is given for information.
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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