prEN ISO 10555-1
(Main)Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO/DIS 10555-1:2022)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO/DIS 10555-1:2022)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO/DIS 10555‑1:2022)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO/DIS 10555-1:2022)
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO/DIS 10555-1:2022)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 10555-1:2023
01-januar-2023
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve
(ISO/DIS 10555-1:2022)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
(ISO/DIS 10555-1:2022)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen (ISO/DIS 10555-1:2022)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences
générales (ISO/DIS 10555-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 10555-1
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 10555-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 10555-1:2023
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oSIST prEN ISO 10555-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-1
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2022-11-22 2023-02-14
Intravascular catheters — Sterile and single-use
catheters —
Part 1:
General requirements
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 1: Exigences générales
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
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Reference number
NATIONAL REGULATIONS.
ISO/DIS 10555-1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-1
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
Intravascular catheters — Sterile and single-use
catheters —
Part 1:
General requirements
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 1: Exigences générales
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
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© ISO 2022
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 10555-1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 5
4.1 Risk approach . 5
4.2 Usability engineering . . 5
4.3 Sterilization . 5
4.4 Shelf life. 5
4.5 Detectability . 5
4.6 Biocompatibility . 5
4.7 Surface . 5
4.8 Corrosion resistance . 6
4.9 Peak tensile force . 6
4.10 Freedom from leakage during pressurization . 7
4.11 Freedom from leakage during aspiration . 7
4.12 Hubs . . 8
4.13 Flowrate . 8
4.14 Power injection burst pressure . 8
4.15 Packaging system . . 8
4.16 Simulated use, kink and/or torque testing to consider depending on device design,
intended use, and risk analysis . 8
4.17 Coating integrity and/or particulate testing to consider depending on device
design, intended use, and risk analysis . 9
4.18 Distal tip stiffness testing to consider for neurovascular applications . 9
5 Designation of nominal size . 9
5.1 Nominal outside diameter . 9
5.2 Nominal inside diameter . 9
5.3 Nominal effective length . 9
6 Information to be supplied with the catheter .10
6.1 General . 10
6.2 Marking on the device and/or primary packaging . 10
6.3 Instructions for use . 11
6.4 Marking on the secondary packaging . 11
Annex A (normative) Test method for corrosion resistance.12
Annex B (normative) Method for determining peak tensile force .13
Annex C (normative) Test method for liquid leakage under pressure .16
Annex D (normative) Test method for air leakage into hub assembly during aspiration .18
Annex E (normative) Determination of flowrate through catheter .20
Annex F (normative) Test for burst pressure under static conditions .22
Annex G (normative) Power injection tests for flowrate and device pressure (only for
products indicated for power injection) .25
Annex H (informative) Units of measurement systems other than those specified in
this document, which may additionally be used .30
Annex I (normative) Test method for air leakage under water .32
Annex J (informative) Rationale and guidance.34
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ISO/DIS 10555-1:2022(E)
Annex K (informative) Test methods .40
Bibliography .41
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(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 of 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
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 third edition cancels and replaces the second edition (ISO 10555-1:2013), which has been
technically revised. It also incorporates amendment ISO 10555-1:2013/Amd 1:2017.
The main changes compared to the previous edition are as follows:
― Added definitions on “inside diameter”, “gauge length”, and “coating” (Clause 3)
― Added clarification on requirements (Clause 4) related to the following aspects:
― Peak tensile force
― Leakage during pressurization: option for air pressure test (Annex I)
― Power injection burst pressure
― Added new requirements (Clause 4) related to the following aspects:
― Risk approach
― Usability engineering
― Shelf life
― Removal of side holes and distal tip
― Packaging system
― Simulated use, kink and torque
― Coating integrity, particulate
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
― Distal tip stiffness
― Added text on “Nominal inside diameter for some applications” (Clause 5)
― Added test details in the instructions for use for power injection (Clause 6)
― Clarified “conditioning time” and “gauge length” (Annex B)
― Clarified “minimum outside pressure requirement” (Annex D)
― Introduced alternative test method using constant flowrate source (Annex G)
― Added new Annex I for alternative leakage under pressurization using air pressure.
― Added new Annex J Rationale section
A list of all parts in the ISO 10555 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/DIS 10555-1:2022(E)
Introduction
To be developed, if necessary (not mandatory).
vii
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oSIST prEN ISO 10555-1:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 10555-1:2022(E)
Intravascular catheters — Sterile and single-use
catheters —
Part 1:
General requirements
1 Scope
This document specifies general requirements for intravascular catheters, supplied sterile and intended
for single use, for any application.
This document is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.
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 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
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 http:// www .electropedia .org/
3.1
intravascular catheter
tubular device, single or multilumen, designed to be partially or totally inserted or implanted into the
vascular system for diagnostic and/or therapeutic purposes
1
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
3.2
distal end
end of the catheter inserted furthest into the patient
3.3
distal end configuration
shape of the catheter which is designed to facilitate its manual manipulation through the vascular
system and the placement and anchoring of the distal tip in the chosen location
3.4
proximal end
access end
end of the catheter to which connection to another device can be made
3.5
hub
connector(s) at the proximal end (3.4) of the catheter which may either be integral with the catheter or
be capable of being securely fitted to the proximal end (3.4) of the catheter
3.6
effective length
working length
usable length
length of the catheter, or pre- and post-hydration (3.11) lengths of hydratable catheters, that can be
inserted into the body
Note 1 to entry: See Figure 1 where "l" is denoted as effective length.
2
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
Key
l effective length
1 catheter hub
2 catheter strain reinforcement
3 length mark
4 junction
5 pre-connected port
6 sidearm
Figure 1 — Examples of effective length of catheters
3
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
3.7
outside diameter
largest diameter of the catheter or pre- and post-hydration (3.11) largest diameters of hydratable
catheters over the effective length (3.6)
3.8
inside diameter
for a lumen intended to deliver other devices, the largest diameter that can pass through a catheter
Note 1 to entry: See Annex J for supplementary information.
3.9
junction
joint
fixed connection
joining of one tube or more tubes with another tube or component where the assembly provides
mechanical support in tension/compression during clinical use
3.10
hydratable intravascular catheter
intravascular catheter consisting of a material which, when subjected to an aqueous medium, results in
an increase of more than 1 % of the effective length or 10 % or more of the outside diameter (3.7) of the
effective length in post-hydration (3.11) state compared to pre-hydration
3.11
post-hydration
state of a hydratable intravascular catheter (3.10) after immersion in aqueous medium at (37 ± 2) °C for
a minimum of 2 h or a shorter time upon appropriate clinical justification
3.12
power injection
injection of an imaging contrast agent with a pump capable of generating pressures greater than or
equal to 689 kPa (100 psi)
3.13
primary packaging
packaging, which has direct contact with the device and/or maintains sterility
3.14
secondary packaging
packaging designed to contain one or more primary packages (3.13) and/or accessories
3.15
gauge length
length of the test piece between the grips of the tensile testing apparatus that elongates significantly
during testing
Note 1 to entry: See Figure B.1.
Note 2 to entry: See Annex J for supplementary information.
3.16
coating
layer of material with any different property (e.g. antimicrobial, lubricity, antithrombogenicity) than
the natural surface of the substrate that is intentionally added to the substrate
Note 1 to entry: The coating can partially or fully cover the substrate surface. Liquid lubricant is not considered
as coating.
4
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
4 Requirements
4.1 Risk approach
Risk analysis, risk evaluation, risk control, evaluation of residual risk acceptability shall be performed
in accordance with ISO 14971.
NOTE See Annex J for supplementary information.
4.2 Usability engineering
A usability engineering program shall be developed and implemented in accordance with IEC 62366-1,
which shall include addressing use risks and tests and/or assessments as part of the design verification
and validation.
NOTE See Annex J for supplementary information.
4.3 Sterilization
The devices shall be sterilized by a validated method.
The devices shall fulfil the requirements specified in 4.4 to 4.18 after being sterilized by a sterilization
cycle representative of the final manufacturing process.
NOTE See applicable part(s) of ISO 17665, ISO 11135, and ISO 11137 for appropriate methods of sterilization.
4.4 Shelf life
The impact of aging on product performance shall be considered based on risk assessment in order to
support the shelf life.
4.5 Detectability
Parts of the catheter shall be detectable by X-ray or by other means (e.g. ultra-sound, MRI, etc.) if
required as determined by the risk assessment.
Detectability shall be demonstrated by an appropriate test method (see e.g. ASTM F640-20 or
DIN 13273-7).
4.6 Biocompatibility
The catheter shall be free from biological hazard in accordance with appropriate testing according to
ISO 10993-1.
4.7 Surface
When examined by normal or corrected to normal vision and with a minimum x 2,5 magnification the
external surface of the catheter shall appear free from foreign matter.
The external surface of the effective length of the catheter, including the distal end, shall be free from
surface defects which could cause embolic risks or trauma to vessels.
If the catheter is lubricated, the lubricant shall not be visible as drops of fluid on the external surface
when the catheter is examined under normal or corrected to normal vision.
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
4.8 Corrosion resistance
Metallic components of the catheter intended for fluid path contact shall show no signs of corrosion
when tested in accordance with the method given in Annex A.
4.9 Peak tensile force
Every section of the catheter shall be tested for peak tensile force in accordance with Annex B. Table 1
specifies the minimum peak tensile force for different sized tubular test pieces. Testing can be done on
the complete device or different sections; however, minimum peak tensile force shall meet the minimum
requirements as specified in Table 1. See Figure 2 for examples of catheter sections and determination
of effective outside diameter.
NOTE This document does not specify requirements for peak tensile force for tubing of less than 0,55 mm
outside diameter (prehydration outside diameter for hydratable intravascular catheters). For those cases the
tensile test should be performed in accordance with Annex B and the peak tensile force should be determined by
the manufacturer based on risk assessment.
For a distal tip of lengths less than 3 mm and its junction to the shaft tube, the tensile test method and
the peak tensile force shall be determined by the manufacturer based on risk assessment.
The forces experienced during clinical use may be greater than the values listed in Table 1, e.g. the
expected forces applied to a delivery system during clinical use to access the intended location, to deploy
the device, or to withdraw the system. If the forces experienced during clinical use are determined by
the manufacturer to be greater than the values listed in Table 1, the acceptance criteria for the peak
tensile force of each test piece shall be as determined by the manufacturer based on risk assessment.
NOTE See Annex J for supplementary information.
Table 1 — Peak tensile force of catheter test pieces
Effective outside diameter range Minimum peak tensile force
of tubular portion of test piece
mm N
≥ 0,55 < 0,75 3
≥ 0,75 < 1,15 5
≥ 1,15 < 1,85 10
≥ 1,85 15
NOTE 1 Values listed in Table 1 are not based on clinical data or forces that have been determined to be clinically-
relevant. However, these values have been historically used to support functional performance and may be acceptable with
appropriate rationale.
NOTE 2 See Annex J for supplementary information.
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
Key
d effective outside diameter
e
A tubing
A tubing
1
A tubing
2
B grip
C hub
1 tubular section only
2 junction
3 tapered section
4 entire device
Figure 2 — Illustration of effective outside diameter
NOTE See Annex J for supplementary information.
4.10 Freedom from leakage during pressurization
If subjected to liquid pressure during intended use, the hub or connection fitting assembly or any other
part of the catheter shall not leak when tested using either liquid pressure as set out in Annex C or air
pressure in accordance with Annex I.
For hydratable intravascular catheters, this requirement shall be met in both the pre- and post-
hydration states.
NOTE See Annex J for supplementary information.
4.11 Freedom from leakage during aspiration
If subjected to aspiration during intended use, 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.
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oSIST prEN ISO 10555-1:2023
ISO/DIS 10555-1:2022(E)
4.12 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 80369-7.
4.13 Flowrate
For devices for which flow rate is defined, when tested in accordance with Annex E for all catheter
lumen indicated for gravity delivery of fluid, the flow rate for each lumen shall be a minimum of 80 % of
that stated in the information supplied by the manufacturer for catheters of nominal outside diameter
less than 1,0 mm or a minimum of 90 % of that stated in the information supplied by the manufacturer
for catheters of nominal outside diameter equal to or greater than 1,0 mm.
If the flowrate through hydratable catheters is determined, it shall be determined in post-hydration
states.
4.14 Power injection burst pressure
If a catheter lumen is indicated for power injection, it shall be tested according to Annexes F and G. In
Annex G, either test A or B may be used. The lumen burst pressure (per Annex F) shall exceed the peak
pressure present in that lumen (per Annex G) when flowing at the maximum flowrate stated in the
information supplied by the manufacturer.
If desired, each fluid path may be divided into zo
...
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