EN ISO 10555-6:2017

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
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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 .
...