ISO 20697:2018

INTERNATIONAL ISO
STANDARD 20697
First edition
2018-06
Corrected version
2018-09
Sterile drainage catheters and
accessory devices for single use
Sondes et dispositifs auxiliaires stériles de drainage non réutilisables
Reference number
©
ISO 2018
© ISO 2018
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Published in Switzerland
ii © ISO 2018 – All rights reserved

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 Drainage 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 drainage catheter .20
Annex H (informative) Test method for retention strength .22
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 (drainage catheter with compliant balloon) .27
Annex K (normative) Test method for determining balloon size and deflation reliability
(drainage 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
iv © ISO 2018 – All rights reserved

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.
This corrected version of ISO 20697:2018 incorporates the following corrections:
— correction of measurements and units in 6.9.3, 6.10, H.2.2 a) and L.2.1;
— deletion of EN 980 from Bibliography;
— minor editorial changes.
Introduction
Guidance on transition periods for implementing the requirements of this document is given in ISO/
TR 19244.
vi © ISO 2018 – All rights reserved

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.
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
length of the drainage catheter (3.5), or pre- and post-hydration lengths of hydratable catheters, that
can be inserted into the body
3.8
overall length
L
total length from the tip of the drainage catheter (3.5) to the end of the funnel (3.10)
3.9
effective shaft length
L
length of non-perforated portion of the drainage catheter (3.5) excluding the tip, balloon(s), funnel(s)
(3.10), protective sleeves and/or access port(s)
3.10
funnel
proximal portion of the drainage catheter (3.5), which may be connected to a drainage system (3.7)
2 © ISO 2018 – All rights reserved

3.11
retention means
physical feature of the drainage catheter (3.5) within the body that prevents movement of the drainage
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:—, 3.18]
3.13
risk analysis
systematic use of available information to identify hazards and to estimate the risk (3.12)
[SOURCE: ISO 14971:—, 3.19]
3.14
risk assessment
overall process comprising a risk analysis (3.12) and a risk evaluation
[SOURCE: ISO 14971:—, 3.20]
3.15
risk management file
set of records and other documents that are produced by risk management
[SOURCE: ISO 14971:—, 3.25]
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.
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 drainage 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 drainage 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 drainage 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 drainage 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 (FG, 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.
4 © ISO 2018 – All rights reserved

Key
1 funnel L effective length
2 lateral drainage holes L overall length
3 inflation connection L effective shaft length
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.
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 drainage 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 the connections
Smallest outer diameter of tubular
Minimum peak tensile force
portion of connected devices
N
mm
≥2 and ≤4 5
>4 15
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.
6 © ISO 2018 – All rights reserved

Compliance shall be checked by using the peak tensile force test method in Annex D.
6.4.2 Drainage catheters and other accessory devices
The minimum peak tensile force of each tubular portion, each junction between drainage catheter
component and tubing, and each junction between tubular portions shall be as given in Table 2.
Table 2 — Peak tensile force of drainage catheters and other accessory devices
Smallest outer diameter of tubular
Minimum peak tensile force
portion of test piece
N
mm
≥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 by using the peak tensile force test method in Annex E.
6.5 Impact resistance
When tested, the collection device shall not leak and the suction source shall not show any loss of
vacuum greater than 2 %.
Compliance shall be checked by using the impact resistance test method in Annex F.
6.6 Flow rate
For drainage catheters for which flow rate is claimed, the flow rate for each lumen shall be a minimum
of 80 % of that stated by the manufacturer for drainage catheters of nominal outside diameter less than
1,0 mm or a minimum of 90 % of that stated by the manufacturer for drainage catheters of nominal
outside diameter equal to 1,0 mm or greater.
If the flow rate through hydratable catheters is determined, it shall be determined in post-hydration
states.
Compliance shall be checked by using the flow rate test method in Annex G.
6.7 Retention strength
If the drainage catheter has retention means other than a balloon, it shall demonstrate the ability to
prevent undesired dislodgement. This document does not specify requirements for retention strength
testing. Clinically relevant retention value is determined by the manufacturer based on intended use
and risk assessment.
NOTE A test method for retention strength is shown in Annex H.
6.8 Balloon safety
If the drainage catheter has a balloon, the balloon shall not leak and shall not occlude the lateral
drainage holes.
Compliance shall be checked by using the balloon safety test method in Annex I.
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 nominal balloon inflation volume.
6.9 Drainage catheter inflation lumen integrity and volume maintenance
6.9.1 General
If a balloon is present, the appropriate requirement from 6.9.2 and 6.9.3 applies.
6.9.2 Compliant balloon
When deflating the balloon, the percentage of water recovered shall not be lower than the value given
in Table 3.
Table 3 — Balloon 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 J.
6.9.3 Non-compliant balloon
For 4,0 mm (12 French) and larger catheters, the balloon shall pass through a French size scale no
greater than four (4) French larger than the label French size.
This document does not specify requirements for drainage catheter sizes less than 4,0 mm (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 K.
6.10 Inflated balloon resistance to traction
For drainage catheters 4,66 mm to 8,66 mm (14 French to 26 French), the balloon shall not pass into
or through a funnel-like apparatus, with a size 28 French lumen, representing the bladder outlet and
urethra.
This document does not specify requirements for drainage catheter sizes less than 14 French. These
values should be determined by the manufacturer based on risk assessment.
Compliance shall be checked using the test method in Annex L.
6.11 Freedom from leakage during aspiration or vacuum
The drainage catheter, accessory devices, or any component(s) designed to form a part thereof, intended
to operate under negative pressure shall not leak air during aspiration at the maximum negative
pressure as defined by the manufacturer.
Compliance shall be checked by using the test method in Annex M.
8 © ISO 2018 – All rights reserved

7 Information supplied by the manufacturer
7.1 General
Units of measurement systems other than those specified may additionally be used.
Marking on all devices shall be durable and legible. Check compliance by inspection and assess
durability by use of appropriate test method.
NOTE Appropriate test methods can be ASTM F1842-09 or ASTM F2252-13.
Where appropriate, ISO 11607 (all parts) and EN 1041 should be used and symbols should be made
according to ISO 15223-1.
7.2 Marking on the device and/or packaging
NOTE The primary packaging is often transparent. Therefore, for the purposes of this subclause, the
combination of marking of the device which is visible through the package and the primary packaging itself are
to be considered.
If not practicable on the device itself then marking should be displayed on the primary (individual)
packaging, secondary (case) packaging or in the instructions for use.
The primary and/or secondary packaging shall be labelled with the following information at a minimum.
a) Any special storage or handling conditions.
b) An indication that the device is for single use or single patient use. A manufacturer's indication of
single use shall be consistent across its range, where appropriate.
c) Where appropriate, an indication of whether the device is detectable.
d) If present, effective collection capacity of the collection device expressed in millilitres.
e) The vacuum stability of any pre-evacuated suction source, defined as the date when at least 80 % of
the initial negative pressure as stated on the label will remain.
NOTE This can be the “use until date” as defined in EN 1041.
f) Where appropriate, the maximum negative pressure in pascals (Pa) which the drainage system, or
any component thereof supplied separately, can withstand (if the suction source is supplied with
the system, this value should be the maximum operating pressure of the suction source).
g) Where appropriate, the manufacturer’s stated nominal balloon inflation volume.
7.3 Instructions for use
When a separate instruction for use is provided, it shall at least contain information on the following.
a) If the intended purpose of the device is not obvious to the user, the manufacturer shall clearly state
it. Where a device is provided with separate instructions for use, this requirement may be omitted
from the primary packaging.
b) If the device is intended to be connected to other devices or accessories in order to operate as
required for its intended purpose, sufficient details of its characteristics to identify the correct
devices in order to obtain a safe combination.
c) Any warnings or precautions to take.
d) Date of issue or the revision level of the instructions for use.
e) Where appropriate, an indication that the device is for single use or single patient use. A
manufacturer's indication of single use shall be consistent across its range.
f) Where appropriate, the method of cleaning, disinfecting or sterilization necessary prior to use.
g) Where appropriate, known reactions between the drainage catheter and magnetic resonance
imaging (MRI) environment.
h) Where appropriate, description of additives or coatings.
i) Any contra-indications, warnings and precautions based on the additive or coating material(s).
j) If the drainage catheter has retention means, instructions for tightening and release of retention.
10 © ISO 2018 – All rights reserved

Annex A
(informative)
Test method for determining kink stability
A.1 Principle
The device is wrapped around incrementally smaller mandrels until a kink is formed.
A.2 Apparatus
A.2.1 Kink fixture, mandrel with incrementally smaller diameters.
NOTE Typical apparatus can be found in Figure A.1.
A.2.2 Calipers.
A.3 Procedure
A.3.1 Select a test piece from the device to be tested. Each tubular portion and each junction between a
tubular portion are tested individually.
A.3.2 Place the test pieces to be conditioned in an appropriate aqueous medium at (37 ± 2) °C for
a clinically appropriate period of time or a minimum of 2 h. Test in accordance with A.3.3 to A.3.5
immediately after conditioning.
A.3.3 Hold the tubing in both hands, wrap it 180° around a large diameter mandrel to avoid kinking the
drainage catheter prematurely.
A.3.4 Continue to wrap the tubing around smaller diameters incrementally until a kink is observed in
the tubing.
A.3.5 Once the tubing has kinked, measure the diameter of the mandrel with calipers or record the
mandrel diameter.
A.4 Test report
The test report shall include the following information:
a) identity of the drainage catheter;
b) the diameter of the mandrel, expressed in millimetres.
Dimensions in millimetres
Key
⌀ mandrel diameter
NOTE 1 Diameter could be engraved on each step.
NOTE 2 The apparatus in the Figure is an example that has been found to be suitable, but is not intended to
preclude other sizes of apparatus or other designs from being used, as long as a simple loop is being formed.
Figure A.1 — Apparatus for testing tubing until kinking
12 © ISO 2018 – All rights reserved

Annex B
(normative)
Test method for corrosion resistance
B.1 Principle
The device is immersed in sodium chloride solution, then in boiling distilled or deionized water, and
afterwards examined visually for evidence of corrosion.
B.2 Reagents
B.2.1 Saline solution, comprising a solution of analytical reagent grade sodium chloride in freshly
prepared distilled or deionized water, [c(NaCl) = 0,15 mol/l].
B.2.2 Distilled or deionized water.
B.3 Apparatus
B.3.1 Borosilicate glass beakers.
B.4 Procedure
B.4.1 Immerse the device in the saline solution (B.2.1) in a borosilicate glass beaker (B.3.1) at
(22 ± 5) °C for 5 h.
B.4.2 Remove the test specimen and immerse it in boiling distilled or deionized water (B.2.2) for 30 min.
B.4.3 Allow the water and the test specimen to cool to (37 ± 2) °C, and maintain them at this
temperature for 48 h.
B.4.4 Remove the test specimen and allow it to dry at room temperature.
B.4.5 Disassemble specimens that have two or more components, which are intended to be separable
in use. Do not strip away or cut open any coatings on metallic components. Inspect the specimen visually
for signs of corrosion.
NOTE Additional testing can be performed using alternate durations and temperatures using appropriate
risk-based clinical justification.
B.5 Test report
The test report shall include the following information:
a) identity of the device;
b) statement as to whether corrosion occurred during the test.
Annex C
(normative)
Test method for resistance to deformation by suction
C.1 Principle
The drainage catheter, accessory devices, or any component(s) designed to form a part thereof,
assembled in a ready-to-use state, are exposed to the negative pressure stated on the label. The test
specimen is inspected while under the negative pressure for evidence of deformation.
C.2 Apparatus
C.2.1 Water bath, at (37 ± 2) °C.
C.3 Procedure
C.3.1 Perform the test on the ready-for-use product.
C.3.2 Condition those parts of the drainage catheter that are intended for insertion into the body in
an atmosphere of 100 % RH or water at a temperature of (37 ± 2) °C (C.2) for not less than 15 min.
Condition other components at a minimum of 40 % RH and at a temperature of (22 ± 2) °C for not less
than 15 min.
C.3.3 Test immediately after conditioning.
C.3.4 Connect the non-perforated section of the drainage catheter and/or the drainage catheter
with accessory devices, and/or the individual components thereof (if supplied separately). Apply the
maximum negative pressure as defined by the manufacturer to the system for at least 60 s.
C.3.5 Examine the test specimen by normal or corrected-to-normal vision during the test for evidence
of deformation.
C.4 Test report
The test report shall include the following information:
a) identity of the drainage catheter;
b) statement as to whether deformation occurred during the test.
14 © ISO 2018 – All rights reserved

Annex D
(normative)
Test method for determining peak tensile force of connections
D.1 Principle
The connector(s) are assembled in accordance with the manufacturer’s instructions. A peak tensile
force is applied and the assembled connection is inspected for separation.
D.2 Apparatus
D.2.1 Tensile testing apparatus, capable of exerting a force of greater than 15 N.
D.3 Procedure
D.3.1 Assemble the connectors in accordance with the manufacturer’s instructions.
D.3.2 Fix the assembled connectors in the tensile testing apparatus. If necessary, use an appropriate
fixture to avoid deforming the connectors.
D.3.3 Apply the specified peak tensile force at a testing speed of 500 mm/min.
D.3.4 Inspect the assembled connectors for separation.
D.4 Test report
The test report shall include the following information:
a) identity of the drainage catheter;
b) identity of the connector(s);
c) the specified force applied, in newtons;
d) statement as to whether the connectors separated during the test.
Annex E
(normative)
Test method for determining peak tensile force of drainage
catheter
E.1 Principle
Test pieces or the overall length of a drainage catheter are chosen so that each tubular portion, each
junction between drainage catheter component and tubing, and each junction between tubular portions
is tested. A tensile force is applied to each test piece until the tubing breaks or the junction separates or
until a specified force is applied.
E.2 Apparatus
E.2.1 Water bath, at (37 ± 2) °C.
E.2.2 Tensile testing apparatus, capable of exerting a force of greater than 20 N.
E.3 Procedure
E.3.1 Select a test piece from the drainage catheter to be tested. Include in the test piece the connector,
if present, and the junction between segments, e.g. between the tubing and the tip, if present. Exclude
distal tips of lengths less than 3 mm from the test piece.
E.3.2 Condition those parts of the drainage catheter that are intended for insertion into the body in an
atmosphere of 100 % RH or water at a temperature of (37 ± 2) °C (E.2.1) for not less than 2 h. Condition
other components at a minimum of 40 % RH and at a temperature of (22 ± 5) °C for not less than 2 h. Test
immediately after conditioning.
E.3.3 Fix the test piece in the tensile testing apparatus. If a connector is present, use an appropriate
fixture to avoid deforming the connector.
E.3.4 Measure the gauge length of the test piece, i.e. the distance between the jaws of the tensile testing
apparatus or the distance between the connector and the jaw holding the other end of the test piece, as
appropriate.
E.3.5 Apply a tensile strain at a unit strain rate of 20 mm/min/mm of gauge length (see Table E.1) until
the test piece separates into two or more pieces, or until a specified force is applied.
Table E.1 — Examples of conditions for a 20 mm/min/mm strain rate
Gauge length Testing speed
mm mm/min
10 200
20 400
25 500
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E.3.6 If testing a drainage catheter that consists of a single tubular portion having regions of different
outside diameter, repeat E.3.2 to E.3.5 on test pieces of each different diameter.
E.3.7 Do not perform more than one test on each test piece.
E.4 Test report
The test report shall include the following information:
a) identity of the drainage catheter;
b) the peak tensile force, or the specified force applied, in newtons;
c) outer diameter of each test piece;
d) and if appropriate, the location of the failure.
Annex F
(normative)
Test method for impact resistance of collection device
F.1 Principle
The collection device is submitted to free fall onto a hard surface and is then examined for evidence of
damage in the form of leakage or loss of vacuum.
F.2 Apparatus
F.2.1 Test surface, which is:
— flat and horizontal, so that no more than two points on its surface differ in level by more than 2 mm;
— rigid, so that it will not be deflected by more than 0,1 mm when an area of 100 mm is loaded
statically with 98 N anywhere on the surface;
— sufficiently large that the device under test falls entirely upon its surface;
— has a mass of at least 10 times that of the heaviest device to be tested.
F.2.2 Means for measuring vacuum, capable of showing a difference of 2 % of the maximum vacuum.
F.2.3 Means for occlusion of the inlet/suction port, where applicable.
F.3 Procedure
F.3.1 Collection device
F.3.1.1 Assemble the collection device as for clinical use.
F.3.1.2 Fill the collection device with water to its collecting capacity. Disconnect the collection device.
Occlude the inlet/suction port, where applicable.
F.3.1.3 Perform a free fall at an ambient temperature of (22 ± 5) °C from a height of 700 mm onto a
hard surface (F.2.1). Inspect for leakage by normal or corrected-to-normal vision.
F.3.2 Suction source
F.3.2.1 Assemble the suction source as for clinical use. If the device does not have means for self-
occluding the inlet/suction port, connect the means for occlusion and occlude the inlet/suction port.
F.3.2.2 Ensure the suction source is at the maximum negative pressure and measure and record the
pressure.
F.3.2.3 Perform a free fall at an ambient temperature of (22 ± 5) °C from a height of 700 mm onto a
hard surface (F.2.1).
18 © ISO 2018 – All rights reserved

F.3.2.4 Measure and record the pressure not less than 60 s after impact.
F.4 Test report
The test report shall include the following information:
a) identity of the test device(s);
b) for suction sources, the maximum negative pressure at the beginning of the test and the negative
pressure after test, expressed in kPa;
c) the statement whether leakage was observed after test.
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