SIST EN ISO 10555-6:2017

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

• Status: Published
• Public Enquiry End Date: 14-Jun-2017
• Publication Date: 11-Sep-2017
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 31-Aug-2017
• Due Date: 05-Nov-2017
• Completion Date: 12-Sep-2017
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10555-6:2017 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

Relations

• Amended By: SIST EN ISO 10555-6:2017/A1:2019 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
• Effective Date: 01-Dec-2019

Overview

EN ISO 10555-6:2017 (ISO 10555-6:2015) specifies requirements, performance and user-safety provisions for sterile, single‑use subcutaneous implanted ports and their intravascular catheters intended for long‑term vascular access. The standard covers design, marking, packaging, testing and information to be supplied by manufacturers. It does not cover requirements for non‑coring needles.

Keywords: ISO 10555-6, EN ISO 10555-6:2017, subcutaneous implanted ports, intravascular catheters, sterile single‑use catheters.

Key topics and technical requirements

• Scope and applicability - Devices for long‑term intravascular use supplied sterile and for single use. Excludes non‑coring needles.
• Biocompatibility - Requirements to address material safety for implanted port components.
• Physical requirements - Includes radio‑detectability, surface finish, freedom from leakage, flushing volume and septum characteristics.
• Connection and catheter characteristics - Specifications for the port–catheter connection and catheter dimensions.
• Flow rate and burst pressure - Clauses distinguish devices indicated for routine infusion vs. those indicated for power injection (high‑pressure injection), with related flow and burst pressure considerations.
• MRI compatibility - Requirements and guidance for assessing device behaviour in magnetic resonance imaging environments.
• Labelling, traceability and instructions for use - Marking on device, primary packaging requirements, batch/lot identification and required user information (including power injection limits if applicable).
• Test methods and annexes - Normative and informative annexes describe methods for leakage testing, flushing volume determination, needle penetration/withdrawal characterization, multiple puncture testing and peak tensile force.

Practical applications and users

EN ISO 10555-6 is essential for:

• Medical device manufacturers designing and producing subcutaneous ports and catheters - to meet harmonized performance and safety expectations.
• Quality, regulatory and compliance teams preparing technical files and demonstrating conformity with EU medical device directives and national standards.
• Test laboratories performing bench testing (leakage, burst pressure, tensile force, MRI assessment).
• Procurement and clinical engineering evaluating product specifications for long‑term vascular access and power injection suitability.
• Clinicians who need clarity on device limitations (e.g., power injection rating, flushing volume) and safe use information.

Related standards

• ISO 10555-1:2013 (general requirements for intravascular catheters)
• ISO 10555-3:2013 (other specific catheter types)
• Other ISO/IEC standards referenced in EN ISO 10555-6 for test and safety methods

Use EN ISO 10555-6:2017 for product development, regulatory compliance and to ensure safe, standardized performance of implanted vascular ports and their catheters.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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
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.
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
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.
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.
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
ISO 10555-6:2015(E)
© 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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved

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 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

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
...