FINAL INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 10555-7
ISO/TC 84
Secretariat: DS Intravascular catheters — Sterile and
Voting begins on:
single-use catheters —
2023-09-26
Part 7:
Voting terminates on:
2023-11-21
Peripherally inserted central
catheters
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Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 7: Cathéters centraux à insertion périphérique
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ISO/FDIS 10555-7
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ISO/FDIS 10555-7:2023(E)
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ISO/FDIS 10555-7:2023(E)
Contents Page
Foreword......................................................................................................................................................................................................................................... iv
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 Requirements........................................................................................................................................................................................................... 2
4.1 General............................................................................................................................................................................................................ 2
4.2 Distance markings............................................................................................................................................................................... 2
4.3 Lumen markings.................................................................................................................................................................................... 2
4.4 Peak tensile force.................................................................................................................................................................................. 2
4.4.1 General......................................................................................................................................................................................... 2
4.4.2 Catheters excluding the tip........................................................................................................................................ 2
4.4.3 Tip tensile force.................................................................................................................................................................... 2
4.5 Information to be supplied by the manufacturer..................................................................................................... 3
Annex A (informative) Rationale and guidance...................................................................................................................................... 4
Bibliography................................................................................................................................................................................................................................. 5
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ISO/FDIS 10555-7:2023(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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
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assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
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prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters. a612bd1b9584/iso-fdis-10555-7
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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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 10555-7:2023(E)
Intravascular catheters — Sterile and single-use
catheters —
Part 7:
Peripherally inserted central catheters
1 Scope
This document specifies general requirements and test method for peripherally inserted central
catheters (PICC), supplied in the sterile condition and intended for single use, for any application.
It 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
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undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10555-1, Intravascular catheters — Sterile and single-use catheters — Part 1: General Requirements
(standards.iteh.ai)
ISO 10555-3, Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
3 Terms and definitions ISO/FDIS 10555-7
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For the purposes of this document, the terms and definitions given in ISO 10555-1 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://w ww.iso.org/obp
— IEC Electropedia: available at https://w ww.electropedia.org/
3.1
peripherally inserted central catheter
PICC
type of central catheter where the tip resides centrally but the insertion into the vasculature is
performed in the peripheral veins (typically upper arm, but other peripheral sites as well)
3.2
outside diameter
largest diameter of the catheter or pre- and post-hydration largest diameters of hydratable catheters
along the non-tapered length
Note 1 to entry: The tapered length is the proximal portion of the effective length where the nominal diameter of
the catheter is gradually increased (from distal to proximal direction).
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ISO/FDIS 10555-7:2023(E)
4 Requirements
4.1 General
Catheters shall conform to ISO 10555-1, except for the peak tensile force for which the requirements in
4.4 of this document shall apply.
4.2 Distance markings
If the catheter is provided with distance markings, the marking system shall indicate the length of the
catheter. From the first mark, the distance between marks shall not exceed 5 cm.
4.3 Lumen markings
For multi-lumen catheters, the identification of each lumen shall be apparent to the user, and for
catheters with staggered tips (exit points) the relative position of the distal opening to the tip of the
catheter shall be apparent to the user.
4.4 Peak tensile force
4.4.1 General
Test the catheter for peak tensile force in accordance with ISO 10555-1 using the requirement values
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listed in the following subclauses.
4.4.2 (standards.iteh.ai)
Catheters excluding the tip
a) For catheters not constructed with silicone materials, the peak tensile force of each test piece shall
be as given in ISO 10555-1. ISO/FDIS 10555-7
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b) For catheters constructed with silicone materials, the peak tensile force shall be as given in Table 1.
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This document does not specify requirements for peak tensile force for tubing of less than 0,75 mm
outside diameter (pre-hydration outside diameter for hydratable intravascular catheters). For those
cases, the peak tensile force shall be determined by the manufacturer based on risk assessment.
Table 1 — Peak tensile force of silicone catheter test pieces
Effective outside diameter range of Minimum peak tensile
tubular portion of test piece force
mm N
≥ 0,75 and < 1,15 1,6
≥ 1,15 and < 1,85 3,4
NOTE See Annex A for supplementary information.
4.4.3 Tip tensile force
For catheter tips not exceeding 20 mm in length, the minimum peak tensile force of the tip shall be
as given in Table 1 for silicone-based catheters and as given in Table 2 for any other material-based
catheters when tested in accordance with the method given in ISO 10555-1.
For distal tips of less than 3 mm length, the peak tensile force requirement shall be as given in
ISO 10555-1.
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ISO/FDIS 10555-7:2023(E)
Table 2 — Minimum peak tensile force of tips of length not exceeding 20 mm
(for non-silicone PICCs)
Smallest outside diameter of Minimum peak tensile
catheter body force
mm N
≥ 0,55 and < 0,75 3
≥ 0,75 and < 1,85 4
≥ 1,85 5
4.5 Information to be supplied by the manufacturer
Information supplied by the manufacturer shall conform to ISO 10555-1 and ISO 10555-3 and shall also
indicate, for each lumen, whether the lumen is compatible with power injection.
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ISO/FDIS 10555-7:2023(E)
Annex A
(informative)
Rationale and guidance
A.1 General
This annex provides a rationale for tensile requirements for silicone catheters of this document.
A.2 Background
The peak tensile requirements for the catheter shaft and associated junctions were established in 1995
with the first edition of ISO 10555-1 (ISO 10555-1:1995, Table 1). These requirements have remained
unchanged since the first edition. Prior to 1995, small-bore silicone PICCs [< 5 Fr (1,67 mm) outer
diameter] were present on the market and some of these products are still in use to this day. One of
the notable aspects of these small-bore silicone PICCs is that many of these products do not meet the
peak tensile requirements, even though some products predate the original publication of ISO 10555-1
by 5 years to 10 years. As such, an assessment of the current state of silicone PICCs on the market
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was undertaken to determine whether a more appropriate tensile standard was necessary for these
products.
A.3 Method
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In order to capture an accurate picture of theISO/FDIS
silicone PICCs currently on the market, a benchmarking
10555-7
of silicone PICCs was conducted. Catheters from 5 different manufacturers were used, ranging in size
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from 1,98 Fr to 4 Fr (0,66 mm to 1,33 mm), with a requirement that a minimum sample size of N = 10
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per catheter configuration be provided for testing. The catheters were tested for shaft tensile and shaft
to hub tensile at 3 different manufacturer's laboratories in order to ensure unbiased testing.
A.4 Findings and discussion related to Table 1
The conclusions from the benchmarking testing were that almost all of the silicone catheters tested
did not meet the tensile requirements in the first edition of ISO 10555-1 (ISO 10555-1:1995, Table 1),
which raises questions about the origins of the tensile requirements and whether silicone catheters
on the market in 1995 were adequately considered when developing the tensile requirements. The
catheter shaft and shaft to hub tensile data were pooled for each French size, and the 3 Fr (1 mm) and
4 Fr (1,33 mm) catheter data were further analysed to determine an appropriate tensile specification
for these two sizes of silicone PICCs. Using a requirement of 95 % CI/95 % reliability, a tensile value
that captured 95 % of the tensile values was generated and is shown in Table 1. These values provide
an accurate assessment of the tensile performance of silicone PICCs ranging from 3 Fr to 4 Fr (1 mm to
1,33 mm) and create realistic tensile requirements for this size and material of catheter.
Another important conclusion was that the values listed in Table 1 are only applicable to silicone
catheters. The main reason for this is that, while silicone has a lower tensile value than other materials
commonly used in PICCs (such as polyurethane), silicones have a high elongation at break relative to
other materials. PICCs are subjected to a range of forces while they are implanted in the vasculature.
However, pure axial forces, i.e. those tested in ISO 10555-1:2013, Annex B, are not readily present except
when attempting to remove a catheter where a portion of implanted catheter is adhered to the patient
(i.e. fibrin sheath formation, deep vein thrombosis (DVT), etc.). When these conditions are significant
enough to provide tensile force during removal, the high elongation of silicone provides a visual cue
(“early warning indication”) that the catheter is being subjected to higher-than-normal strain and
further investigation should be conducted before continuing to remove the catheter.
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ISO/FDIS 10555-7:2023(E)
Bibliography
[1] ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires
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