SIST EN ISO 10555-6:2017
(Main)Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 6: Subkutan implantierte Ports (ISO 10555-6:2015)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à cathéter implantables (ISO 10555-6:2015)
L'ISO 10555-6:2015 spécifie les exigences, les performances et les questions liées à la sécurité de l'utilisateur des chambres à cathéter implantables et des cathéters, dans le cadre d'une utilisation intravasculaire de longue durée dans des conditions stériles et à usage unique.
L'ISO 10555-6:2015 ne spécifie pas les exigences, les performances et les questions liées à la sécurité de l'utilisateur des aiguilles non carottantes.
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki (ISO 10555-6:2015)
Standard ISO 10555-6:2015 opredeljuje zahteve, učinkovitost in varnostna vprašanja, povezana s podkožnimi vsadki in katetri za intravaskularno dolgoročno uporabo, ki so dobavljeni sterilni in so namenjeni za enkratno uporabo.
Standard 10555-6:2015 ne določa zahtev, zmogljivosti in varnostnih vprašanj, povezanih z iglami, ki preprečujejo puščanje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10555-6:2017
01-oktober-2017
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki
(ISO 10555-6:2015)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous
implanted ports (ISO 10555-6:2015)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 6: Subkutan
implantierte Ports (ISO 10555-6:2015)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à
cathéter implantables (ISO 10555-6:2015)
Ta slovenski standard je istoveten z: EN ISO 10555-6:2017
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-6:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10555-6:2017
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SIST EN ISO 10555-6:2017
EN ISO 10555-6
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2017
EUROPÄISCHE NORM
ICS 11.040.25
English Version
Intravascular catheters - Sterile and single-use catheters -
Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur
réutilisables - Partie 6: Chambres à cathéter einmaligen Verwendung - Teil 6: Subkutan
implantables (ISO 10555-6:2015) implantierte Ports (ISO 10555-6:2015)
This European Standard was approved by CEN on 30 July 2017.
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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-6:2017 E
worldwide for CEN national Members.
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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
2
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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
European foreword
The text of ISO 10555-6:2015 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 10555-6:2017 by 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 February 2018, and conflicting national standards
shall be withdrawn at the latest by February 2018.
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 has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references as listed in Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
ISO 10555-1:2013 EN ISO 10555-1:2013 ISO 10555-1:2013
ISO 10555-3:2013 EN ISO 10555-3:2013 ISO 10555-3:2013
3
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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
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 10555-6:2015 has been approved by CEN as EN ISO 10555-6:2017 without any
modification.
4
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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/295
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Clause(s) / sub-
Requirements (ER) of clause(s) of this Remarks / Notes
Directive 93/42/EEC EN
7.5 4.2 ER 7.5 is covered only in respect of biocompatibility.
Covers lubricants limited size drops on surfaces in
design and manufacturing.
9.1 4.5.3, 4.5.6.1, 6.4 g) ER 9.1 is covered by Standard Clause 4.5.3 in respect
of leakage only.
ER 9.1 is covered by Standard Clause 4.5.6.1 only in
respect of peak tensile force between the port and
the catheter.
ER 9.1 is covered by Standard Clause 6.4g only in
respect of specifications of the devices required to
connect the port to the power injector.
The connection must be standardized.
The maximum for the connected injector.
The intended purpose should be stated on the label
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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
Essential Clause(s) / sub-
Requirements (ER) of clause(s) of this Remarks / Notes
Directive 93/42/EEC EN
or in the instruction for use, if not obvious.
A pressure limit and maximum flowrate is required
in the instruction for use, if the catheter is indicated
for power injection.
Covers restrictions on use indicated on labelling.
9.2 4.5.3, 4.5.4, 4.6, 4.7, ER 9.2 first dash is covered by Standard Clause 4.5.3
5 in respect of leakage only.
ER 9.2 first dash is covered by Standard Clause 4.5.4
in respect of the flushing volume only.
ER 9.2 first dash is covered by Standard Clause 4.6 in
respect of the flow rate only.
ER 9.2 first dash is covered by Standard Clause 4.7 in
respect of the burst pressure.
ER 9.2 second dash is covered by Standard Clause 5
in respect of MRI compatibility only.
The risk of injury, in connection with physical
features including the volume/pressure ratio and
dimensional features in the design process.
12.7.1 4.5.3, 4.6.2, 4.7.2 ER 12.7.1 is covered by Standard Clause 4.5.3 in
respect of leakage only.
ER 12.7.1 is covered by Standard Clause 4.6.2 in
respect of flow rate only.
ER 12.7.1 is covered by Standard Clause 4.7.2 in
respect of burst pressure only.
The catheter and port must be designed to protect
the patient.
12.9 4.3 ER 12.9 is covered in respect of distance marking on
the catheter only. Indicators for length adjustment.
13.3 a) 6.3 Standard Clause 6.3 first dash covers ER 13.3 a) but
only in respect of the name of the manufacturer and
only provided the labels are located as required by
the Directive.
13.3 b) 6.1, 6.3 Standard Clause 6.1 covers ER 13.3 b) only in respect
of the marking on the actual product.
Standard Clause 6.3 second and third dash covers
ER 13.3 b) but only in respect of the designation and
item number and Batch/Lot/serial number.
13.3 d) 6.3 ER 13.3 d) is covered by Standard Clause 6.3 third
dash but only when the any batch code is preceded
by the word 'LOT'.
Label and traceability label
13.4 6.2, 6.4 ER 13.4 is covered by Standard Clause 6.2 but only in
respect of identification of power injection.
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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
Essential Clause(s) / sub-
Requirements (ER) of clause(s) of this Remarks / Notes
Directive 93/42/EEC EN
ER 13.4 is covered by Standard Clause 6.2 but only in
respect of the information given in Standard Clause
6.4 a-g.
13.6 a) 6.4
13.6 b) 6.4 Only covers devices for power injection.
13.6 c) 6.4 g)
13.6 d) 6.4 c), d)
13.6 e) 6.4 a)
13.6 f) 6.4 e)
13.6 i) 6.4 g)
13.6 l) 6.4 e) Precautions to be taken as regards exposure in
reasonably foreseeable environmental conditions to
magnetic fields.
13.6 n) 6.4 Does not specify 'unusual risk'.
13.6 q) 6.4
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
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SIST EN ISO 10555-6:2017
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SIST EN ISO 10555-6:2017
INTERNATIONAL ISO
STANDARD 10555-6
First edition
2015-04-15
Intravascular catheters — Sterile and
single-use catheters —
Part 6:
Subcutaneous implanted ports
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 6: Chambres à cathéter implantables
Reference number
ISO 10555-6:2015(E)
©
ISO 2015
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SIST EN ISO 10555-6:2017
ISO 10555-6:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
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SIST EN ISO 10555-6:2017
ISO 10555-6:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements of the implantable subcutaneous implanted port and catheter .3
4.1 General . 3
4.2 Biocompatibility . 4
4.3 Distance markings. 4
4.4 Nominal dimensions of the subcutaneous implanted port . 4
4.5 Physical requirements . 4
4.5.1 Radio-detectability . 4
4.5.2 Surface finish . 4
4.5.3 Freedom from leakage . 4
4.5.4 Flushing volume . 4
4.5.5 Characteristics of the septum . 5
4.5.6 Characteristics of the connection or the catheter . 5
4.6 Flow rate . 5
4.6.1 Subcutaneous implanted ports not indicated for power injection . 5
4.6.2 Subcutaneous implanted ports indicated for power injection . 5
4.7 Burst pressure of the subcutaneous implanted port and catheter . 6
4.7.1 Subcutaneous implanted ports not indicated for power injection . 6
4.7.2 Subcutaneous implanted ports indicated for power injection . 6
5 Magnetic Resonance Imaging (MRI) compatibility . 6
6 Information to be supplied by the manufacturer . 6
6.1 Marking on the device . 6
6.2 Primary packaging . 6
6.3 Labels for traceability . 7
6.4 Instruction for use . 7
Annex A (normative) Test method for freedom from air leakage . 8
Annex B (informative) Determination of flushing volume .10
Annex C (informative) Guidance on further characterization testing: Needle penetration
and withdrawal .12
Annex D (normative) Test method for freedom from leakage after multiple punctures .14
Annex E (normative) Peak tensile force .15
Bibliography .16
© ISO 2015 – All rights reserved iii
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SIST EN ISO 10555-6:2017
ISO 10555-6:2015(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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.
ISO 10555 consists of the following parts, under the general title Intravascular catheters — Sterile and
single-use catheters:
— Part 1: General requirements
— Part 3: Central venous catheters
— Part 4: Balloon dilatation catheters
— Part 5: Over-needle peripheral catheters
— Part 6: Subcutaneous implanted ports
The following part has been withdrawn and the content has been included in ISO 10555-1:
— Part 2: Angiographic catheters
iv © ISO 2015 – All rights reserved
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SIST EN ISO 10555-6:2017
INTERNATIONAL STANDARD ISO 10555-6:2015(E)
Intravascular catheters — Sterile and single-use
catheters —
Part 6:
Subcutaneous implanted ports
1 Scope
This part of ISO 10555 specifies requirements, performance, and user safety issues related to
subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition
and intended for single use.
This part of ISO 10555 does not specify requirements, performance, and user safety issues related to
non-coring needles.
NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as
intra-peritoneal, intra-thecal, intra-pleural, and epidural access.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 10555-1:2013, Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 10555-3:2013, Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous
catheters
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10555-1 and the following
apply.
3.1
catheter
single- or multiple-lumen tube allowing access to a point within the body at its distal end
3.2
connection
system connecting the catheter to the subcutaneous implanted port
3.3
effective surface area
area available for puncture by the needle
3.4
flushing volume
volume of solution needed to fully replace one solution from the subcutaneous implanted port and
catheter with another
© ISO 2015 – All rights reserved 1
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SIST EN ISO 10555-6:2017
ISO 10555-6:2015(E)
3.5
non-coring needle
needle that does not produce a core when penetrating the septum
Note 1 to entry: Core is a sliver of septum material that can be produced when a needle perforates a septum.
3.6
outlet tube
exit cannula portion of the subcutaneous implanted port that is connected to the catheter
3.7
priming volume
total amount of space available in the subcutaneous implanted port and catheter to be filled with solution
3.8
priming volume of the subcutaneous implanted port
amount of space available in the subcutaneous implanted port to be filled with solution, where the space
is comprised of both the reservoir and outlet tube
3.9
priming volume of the catheter
total amount of space available in the effective length of the catheter to be filled with solution
3.10
reservoir
open space below the septum that receives the needle and is in communication with the outlet tube
3.11
septum
self-sealing membrane through which the needle passes to communicate with the catheter
3.12
subcutaneous implanted port
device which permits percutaneous access to the catheter
2 © ISO 2015 – All rights reserved
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SIST EN ISO 10555-6:2017
ISO 10555-6:2015(E)
Key
1 septum
2 effective surface area
3 outlet tube
4 reservoir
Figure 1 — Subcutaneous implanted port
Key
1 connection
2 catheter
Figure 2 — Subcutaneous implanted port connected to a catheter
4 Requirements of the implantable subcutaneous implanted port and catheter
4.1 General
Unless otherwise specified in this part of ISO 10555, the subcutaneous implanted port and catheter
shall comply with ISO 10555-1.
© ISO 2015 – All rights reserved 3
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SIST EN ISO 10555-6:2017
ISO 10555-6:2015(E)
4.2 Biocompatibility
Subcutaneous implantable port shall be free from biological hazards.
NOTE See ISO 10993-1 for the selection of appropriate test methods.
4.3 Distance markings
If the catheter is provided with distance markings, the marking shall be indicated as follows:
a) for non-connected catheters, indicate distance from the distal end of the catheter;
b) for pre-connected catheters, indicate distance from the proximal end of the catheter.
From the first mark, the distance between marks shall not exceed 5 cm.
It is recommended that the distance marks be 1 cm apart on that portion of the catheter likely to be of
importance to the user in positioning the catheter and monitoring catheter migration.
4.4 Nominal dimensions of the subcutaneous implanted port
If provided, the following measurements shall be expressed in millimetres:
— subcutaneous implanted port dimensions;
— effective surface area of the septum, defined either as the diameter (in case of a circular septum) or
as the length and width (in case of other shape) of the septum in nominal dimension.
4.5 Physical requirements
4.5.1 Radio-detectability
The radio-detectability shall comply with ISO 10555-1 and shall include the catheter, subcutaneous
implanted port, and connection.
4.5.2 Surface finish
When examined by normal or corrected to normal vision, with a minimum x2,5 magnification, the
surface of the subcutaneous implanted port shall appear free from extraneous matter.
4.5.3 Freedom from leakage
The connection or any other part of the subcutaneous implanted port shall not leak air when tested in
accordance with the method given in Annex A.
When the test is conducted according to Annex A, the subcutaneous implanted port is considered to leak
if the reduction in pressure is greater than 2,65 kPa in 2 min or if a level of 200 kPa cannot be attained.
The septum of the subcutaneous implanted port shall not leak air when tested in accordance with the
method given in Annex D.
4.5.4 Flushing volume
The manufacturer shall conduct characterization tests for the flushing volume. A test method is
described in Annex B. Any other equivalent method may be used.
4 © ISO 2015 – All rights reserved
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SIST EN ISO 10555-6:2017
ISO 10555-6:2015(E)
4.5.5 Characteristics of the septum
4.5.5.1 Needle penetration and withdrawal force
If tested in accordance with Annex C, the peak force of penetration and withdrawal of a non-coring
needle recommended by the manufacturer should be determined.
4.5.6 Characteristics of the connection or the catheter
4.5.6.1 Peak tensile force
For the connection between the port and the catheter, the minimum peak tensile force shall be 5 N when
tested in accordance with Annex E.
The minimum peak tensile force of all other parts of the catheter shall comply with ISO 10555-3:2013,
4.4.
4.6 Flow rate
For devices for which flow rate is defined, when tested in accordance with ISO 10555-1:2013, Annex E,
the flow rate for each lumen shall be a minimum of 80 % of that stated by the manufacturer for catheters
of nominal outside diameter less than 1,0 mm or a minimum of 90 % of that stated by the manufacturer
for catheters of nominal outside diameter equal to 1,0 mm or greater.
If the flowrate through hydratable catheters is determined, it shall be determined in post-hydration
states.
4.6.1 Subcutaneous implanted ports not indicated for power injection
When tested i
...
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