4.6 Peak tensile force When tested in accordance with the method given in Annex B, the peak tensile force of each test piece shall be as given in Table 1.. Table 1 — Peak tensile force o
General
The catheter shall have been sterilized by an appropriate validated method, and shall comply with 4.2 to 4.8 in the sterile condition.
Radio-detectability
Parts of the catheter shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as ASTM F640-12 or DIN 13273-7.
Biocompatibility
The catheter shall be free from biological hazard.
NOTE See ISO 10993-1 for the selection of appropriate test methods.
Surface
When examined by normal or corrected to normal vision, with a minimum x 2,5 magnification the external surface of the effective length of the catheter shall appear free from extraneous matter.
The external surface of the catheter's effective length, including the distal end, must be free from surface defects and processing irregularities that could potentially cause trauma to blood vessels during use, ensuring patient safety and optimal performance.
When lubricating a catheter, ensure that no visible drops of lubricant are present on its external surface upon examination under normal or corrected vision This indicates proper lubrication without excess, promoting safe and effective usage while adhering to hygiene standards.
Corrosion resistance
When tested in accordance with the method given in Annex A, metallic components of the catheter intended for fluid path contact shall show no signs of corrosion.
Peak tensile force
When tested in accordance with the method given in Annex B, the peak tensile force of each test piece shall be as given in Table 1.
Table 1 — Peak tensile force of catheter test pieces
Smallest outside diameter of tubular portion of test piece mm
This section of ISO 10555 does not specify peak tensile force requirements for tubing with an outside diameter of less than 0.55 mm, which includes prehydration outside diameters for hydratable intravascular catheters, nor for the distal tip and its junction to the shaft tube Manufacturers should determine appropriate tensile force values based on risk assessments to ensure safety and performance.
Freedom from leakage
4.7.1 The hub or connection fitting assembly or any other part of the catheter shall not leak liquid when tested in accordance with the method given in Annex C.
For hydratable intravascular catheters, this requirement shall be met in both the pre- and post-hydration states.
4.7.2 Air shall not leak into the hub assembly during aspiration when tested in accordance with the method given in Annex D.
For hydratable intravascular catheters, this requirement shall be met in both the pre- and post-hydration states.
Hubs
If the catheter is supplied with either an integral or a separate hub, it shall be a female hub that shall comply with ISO 594-1 and ISO 594-2.
Flowrate
When testing devices with a defined flow rate according to Annex E, the flow rate for each lumen must meet specific minimum thresholds based on catheter size Specifically, for catheters with a nominal outside diameter of less than 1.0 mm, the measured flow rate should be at least 80% of the manufacturer's stated value For catheters with a nominal outside diameter of 1.0 mm or greater, the flow rate must be at least 90% of the manufacturer's specified flow rate, ensuring device performance and compliance with standards.
If the flowrate through hydratable catheters is determined, it shall be determined in post-hydration states.
Power injection
When selecting a catheter for power injection, it is essential that the burst pressure exceeds the peak pressure experienced during maximum flow conditions, as specified in Annexes F and G This ensures the catheter's safety and reliability during high-volume injections Proper assessment of these pressure limits helps prevent catheter rupture and guarantees optimal performance in clinical procedures.
Side holes
The design, number and positioning of side holes shall be such as to minimize adverse effects on the catheter and trauma to the tissues.
Distal tip
The distal tip shall be smooth, rounded, tapered or similarly finished in order to minimize trauma to vessels during use.
The nominal size of the catheter shall be designated as specified in 5.1 and 5.2.
Outside diameter
According to this International Standard, the outside diameter of a catheter should be specified as the nominal dimension in millimeters unless otherwise stated The measurement must be rounded upwards to the nearest 0.01 mm or 0.1 mm, ensuring precise and standardized sizing for different types of catheters.
For non-round devices, sizing should be based on the largest axis measurement Manufacturers may also provide additional profile details, such as the second axis dimension for oval-shaped devices This ensures accurate identification and compliance with international standards.
Nominal effective length
The nominal effective length shall be expressed in millimetres for effective lengths of less than 100 mm.
The nominal effective length shall be expressed in millimetres or centimetres for effective lengths of
NOTE Tolerances to the effective length are not specified.
6 Information to be supplied by the manufacturer
General
Each device shall be accompanied by the information needed to use it safely and properly All dimensions given shall be expressed in SI units of measurement.
Units of measurement systems other than those specified may additionally be used.
Where appropriate, ISO 15223-1 should be used.
Marking on the device and/or primary packaging
The primary packaging is typically transparent, allowing the device markings to be visible through it For this reason, both the visible markings on the device and the primary packaging itself are considered together when complying with relevant labeling requirements This ensures clear identification and safeguarding of device information during storage and transportation.
The first practical level of device labeling must include the manufacturer’s or authorized representative’s name and address, ensuring traceability It should clearly specify the device’s identity, including the nominal size and packaging contents, along with any guidewire intended for use with the catheter The packaging must prominently display the word “STERILE” or the official ISO 15223-1 symbol to confirm sterility, along with the sterilization method used Additionally, the label must feature the batch code, preceded by ‘LOT’, or a serial number or relevant symbol for effective product tracking and safety.
ISO 15223-1 mandates that medical device labeling includes the expiration date, indicated by the year and month (YYYY-MM), to ensure safety and proper usage It also requires clear markings that specify if the device is for single use, along with any special storage or handling instructions When the device's intended purpose is not immediately obvious, the manufacturer must explicitly state it unless separate instructions for use are provided Additionally, labels should include a prompt to consult the instructions for use when applicable, and for angiographic catheters, a visual or descriptive depiction of the distal end configuration must be included if it is not identifiable through the packaging.
Instructions for use
When providing a separate instructions for use, it must include essential information such as device details (excluding certain sections), safety precautions and warnings, and guidance on connecting the device to compatible accessories or other devices to ensure safe operation Additionally, the instructions should describe any additives or coatings, specify disposal requirements considering these substances, and clarify any special claims related to additives or coatings to ensure user safety and compliance.
— description of the additive or coating material,
— duration of effectiveness in use,
Ensure the instructions include any contraindications, warnings, and precautions related to the additive or coating materials Additionally, specify known reactions between the catheter and magnetic resonance imaging (MRI) procedures The documentation should also include the date of issue or the most recent revision of the instructions for use For devices designed for power injection, include detailed information relevant to their safe and effective use.
— recommended power injector pressure limit setting(s);
— maximum flow rates for a range of clinically applicable viscocities and/or specific injectates.
Marking on the secondary packaging
Where devices are provided in secondary packaging, the marking on the secondary packaging shall include the details referred to in 6.2, if appropriate. © ISO 2014 – All rights reserved 7
Test method for corrosion resistance
The catheter is immersed in sodium chloride solution, then in boiling distilled water, and afterwards examined visually for evidence of corrosion.
A.2.1 Saline solution, comprising a solution of analytical reagent grade sodium chloride in freshly prepared distilled water [c(NaCl) = 0,15 mol/l].
Immerse the catheter in saline solution at room temperature for 5 hours to ensure proper treatment Next, remove the test specimen and immerse it in boiling distilled water for 30 minutes, then allow both to cool to 37°C and maintain at this temperature for 48 hours Afterward, dry the specimen at room temperature and disassemble multi-component specimens if they are designed to be separable during use Avoid stripping coatings from metallic parts and visually inspect the specimen for signs of corrosion to assess its durability.
The test report shall include the following information: a) identity of the catheter; b) statement as to whether corrosion occurred during the test.
Method for determining peak tensile force
When testing catheters, individual test pieces or entire lengths are selected to evaluate every tubular segment, junction between the hub or connector and tubing, and between tubular portions, ensuring comprehensive quality assessment Tensile forces are applied until the tubing fractures or the junction separates, providing critical data on product durability For hydratable catheters, both pre- and post-hydration conditions must be tested, with the worst-case scenario documented to ensure reliability under all usage conditions This testing process is essential for verifying the mechanical integrity and safety of catheter devices.
B.2.1 Tensile testing apparatus, capable of exerting a force of greater than 15 N.
To ensure proper assembly, follow the manufacturer’s instructions carefully when assembling the catheter Select a representative test piece that includes the hub or connector, if present, and the junction between segments, such as between the tubing and distal tip Exclude any distal tips shorter than 3 mm from the test sample to obtain accurate testing results.
To test hydratable catheters, prepare two identical test samples from separate catheters Condition one sample according to section B.3.2, while testing the second sample immediately without conditioning, following procedures B.3.3 to B.3.8 This process ensures accurate comparison of catheter performance under different conditions.
B.3.2 Place the test pieces to be conditioned (see B.3.1) in appropriate aqueous medium at (37 ± 2) °C for a clinically appropriate period of time Test in accordance with B.3.3 to B.3.8 immediately after conditioning.
B.3.3 Fix the test piece in the tensile testing apparatus If a hub or connector is present, use an appropriate fixture to avoid deforming the hub or connector.
To accurately measure the gauge length of the test specimen, position the jaws of the tensile testing apparatus or identify the distance between the hub or connector and the jaw holding the opposite end of the test piece Ensuring precise measurement of this gauge length is essential for reliable tensile testing results.
B.3.5 Apply a tensile strain at a unit strain rate of 20 mm/min/mm of gauge length (see Table B.1) until the test piece separates into two or more pieces Note the peak tensile force in newtons reached by the tensile testing of a catheter test piece before or at the point of separation into two pieces.
B.3.6 If testing a catheter that consists of a single tubular portion having regions of different outside diameter, the test piece should include the smallest diameter.
B.3.7 If testing a catheter that has a sidearm or sidearms, a) repeat B.3.2 to B.3.5 on each sidearm; © ISO 2014 – All rights reserved 9
Repeat steps B.3.2 to B.3.5 on a test sample that includes the joint between a sidearm and the adjacent part of the catheter designed for body insertion Additionally, repeat step B.3.7b) for every joint to ensure proper testing and verification of each connection point.
B.3.8 Do not perform more than one test on any test piece.
Table B.1 — Examples of conditions for 20 mm/min/mm strain rate
The test report shall include the following information: a) identity of the catheter; b) the peak tensile force, in newtons; c) the location of the failure.
Test method for liquid leakage under pressure
The catheter is securely connected through a leakproof connection to a syringe or pressure device, ensuring safety during testing Hydraulic pressure is applied to both the catheter and the hub assembly, if included, to check for any leaks along the catheter tube When testing hydratable catheters, it is essential to evaluate both pre- and post-hydration conditions, documenting the worst-case scenario to ensure reliability and compliance with quality standards.
C.3.1 Leak proof connector, to connect catheter to syringe or a pressure apparatus (C.3.3) fitted with a gauge capable of measuring at least 300 kPa pressure and having a small internal volume.
C.3.2 Connector, to make leak proof connection between syringe or a pressure apparatus (C.3.3) and catheters which do not have hubs.
C.3.3 Syringe of suitable size, which has passed the tests for leakage past the piston and nozzle as specified in ISO 7886-1 or equivalent equipment.
C.3.4 Means for occluding test specimen, e.g a clamp.
When testing catheters with a hub or multiple hubs, assemble detachable hubs according to the manufacturer's instructions Ensure the hub is securely connected to the leak-proof connector (C.3.2) to establish a leak-proof connection, complying with testing standards.
C.4.2 When testing catheters which do not have hubs, connect the catheter to the syringe or pressure apparatus (C.3.3) by means of a connector (C.3.2).
Fill the syringe or pressure apparatus with water at (22 ± 5) °C and expel the air to ensure accurate measurements Adjust the water volume to match the syringe's nominal capacity for precision Occlude the test specimen as close to the distal end as possible to ensure proper testing conditions.
Apply a minimum pressure of 300 kPa and maintain it for 30 seconds to test the catheter system During the test, inspect the catheter and hub assembly, as well as the catheter tube, for any liquid leakage Look for the formation of water drops or falling droplets, indicating a leak Record whether leakage occurs or not to ensure the integrity of the catheter assembly.
C.4.5 For hydratable intravascular catheters, carry out the steps in C.4.1 to C.4.4, considering both pre- and post-hydration states. © ISO 2014 – All rights reserved ``,`,,,````,,,,,,``,`,```,`-`-`,,`,,`,`,,` - 11
The test report must clearly specify the identity of the catheter and indicate whether leakage occurred from the hub assembly or the catheter tube It is essential to include findings for both pre- and post-hydration states, especially for hydratable intravascular catheters, to ensure comprehensive performance assessment.
Test method for air leakage into hub assembly during aspiration
The hub(s) of the catheter is (are) connected to a partially filled syringe A reduced pressure is applied to the interface of the hub and the reference fitting by withdrawing the syringe plunger, and visual inspection made for the ingress of air bubbles to the syringe When testing hydratable catheters, both the pre- and post-hydration states shall be considered; a worst case scenario shall be documented at a minimum.
D.2.1 De-aerated distilled water or de-aerated deionized water.
D.3.1 10 ml syringe which has passed the tests for leakage past the piston and nozzle as specified in ISO 7886-1 or equivalent equipment.
D.3.2 Means for occluding test specimen, e.g a clamp.
Assemble the detachable hubs following the manufacturer's instructions to ensure proper fit and safety Connect the hub to be tested securely to the syringe (D.3.1), creating a leak-proof connection essential for accurate testing Seal all valves that are meant to open during aspiration to prevent any fluid leakage and ensure reliable test results.
To perform the test, draw a volume of water (D.2) at (22 ± 5) °C into the syringe through the test specimen and reference fitting, ensuring the volume exceeds 25% of the syringe’s graduated capacity It is important to avoid wetting the hub or reference fitting union during this process.