EN ISO 10555-1:2009

SLOVENSKI STANDARD
01-september-2009
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SIST EN ISO 10555-1:2000
SIST EN ISO 10555-1:2000/A1:2000
SIST EN ISO 10555-1:2000/A2:2004
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Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-
1:1995, including Amd 1:1999 and Amd 2:2004)
Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine
Anforderungen (ISO 10555-1:1995, einschließlich Änderung 1:1999 und Änderung
2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales
(ISO 10555-1:1995, y compris Amd 1:1999 et Amd 2:2004)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2009
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.

EUROPEAN STANDARD
EN ISO 10555-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.25 Supersedes EN ISO 10555-1:1996
English Version
Sterile, single-use intravascular catheters - Part 1: General
requirements (ISO 10555-1:1995, including Amd 1:1999 and
Amd 2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie Sterile intravaskuläre Katheter zur einmaligen Verwendung
1: Prescriptions générales (ISO 10555-1:1995, y compris -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995,
Amd 1:1999 et Amd 2:2004) einschließlich Änderung 1:1999 und Änderung 2:2004)
This European Standard was approved by CEN on 19 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
The text of ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004 has been prepared by Technical
Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 10555-1:2009 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-1:1996.
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 EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004 has been approved by CEN as a EN
ISO 10555-1:2009 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive …
4 1, 2, 3, 4, 5 Except I 1. first indent –
regarding ergonomics
4.1 6, 7.2, 8.1
4.2 6, 7.1, 7.5 “E.R. 7.5 is only partially
covered: protection against risks
posed by the presence of
phthalates and other toxic
substances are not specifically
addressed”
4.4 6, 7.3
4.6 6, 7.6
4.7 9.1
5 1, 3, 9.2 Except I 1. first indent –
regarding ergonomics
6 3, 13.1, 13.4
6 a) 13.3 b)
6 d) 13.3 a) except 13.3(a) (regarding
representative in the
Community)
6 e) 13.3 d)
6 f) 13.3 e)
6 g) 5
6 h) 13.3 c)
6 i) 13.3 m)
6 j) 13.3 f) Except 13.3 (f) (second phrase
regarding indication of single use
consistent across community)
6 k) 13.3 k)
6 l) 7.3, 13.1, 13.3 i), 13.3 j), 13.3 k),
13.4, 13.6 a), 13.6 b), 13.6 g)
Annex A 1, 2, 3, 4, 5 Except I 1. first indent –
regarding ergonomics
Annex B 1, 2, 3, 4, 5 Except I 1. first indent –
regarding ergonomics
Annex C 1, 2, 3, 4, 5, 7.6 Except I 1. first indent –
regarding ergonomics
Annex D 1, 2, 3, 4, 5, 7.6 Except I 1. first indent –
regarding ergonomics
NOTE 6a Requirement on clinical
evaluation not covered by this
standard
nd
NOTE 13.6 (h) – 2 phrase Regarding information on
known characteristics and
technical factors known to
manufacturer that could pose a
risk if reused is not covered by
this standard
NOTE 13.6 (q) regarding date of issue or latest
revision of instructions for use is
not covered by this standard
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL
ISO
STANDARD 10555-1
First edition
1995-06-15
Sterile, Single-use intravascular
catheters -
1:
Part
General requirements
Cathkters intravasculaires st&iles, non r&tilisables -
Partie 1: Prescrip tions g&Grales
Reference number
ISO 10555-1 :1995(E)
ISO 10555=1:1995(E)
Contents
Page
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5 Designation of nominal size
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
6 Information to be suppl ied by manufacturer
Annexes
..................................... 5
A Test method for corrosion resistance
................................... 6
B Method for determining forte at break
....................... 7
Test method for liquid leakage under pressure
C
Test method for air leakage into hub assembly during aspiration 8
D
..............................................................................
E Bibliography
0 ISO 1995
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronie or mechanical, including photocopying and
microfilm, without Permission in writing from the publisher.
International Organization for Standardization
Gase Postale 56 l CH-1 211 Geneve 20 l Switzerland
Printed in Switzerland
0 ISO
ISO 10555~1:1995(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. Esch 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.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard ISO 10555-1 was prepared by Technical Committee
lSO/TC 84, MedicaI devices for injections, Subcommittee SC 1, Syringes,
needles and in travascular catheters for Single use.
ISO 10555 consists of the following Parts, under the general title Sterile,
Single-use in travascular ca the ters:
- Part 7: General requirements
- Part 2: Angiographic catheters
- Part 3: Cen tral venous catheters
- Part 4: Balloon dila ta tion catheters
- Part 5: Over-needle peripheral catheters
Attention is drawn to ISO 11070, which will specify requirements for ac-
cessory devices for use with intravascular catheters.
Annexes A, B, C and D form an integral part of this part of ISO 10555.
Annex E is for Information only.
. . .
Ill
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INTERNATIONAL STANDARD 0 ISO ISO 10555=1:1995(E)
Sterile, Single-use intravascular catheters -
Part 1:
General requirements
ISO 7886-1 :1993, Sterile hypodermic syringes for sin-
1 Scope
gle use - Part 7: Syringes for manual use.
This part of ISO 10555 specifies general requirements
for intravascular catheters, supplied in the sterile 3 Definitions
condition and intended for Single use, for any appli-
For the purposes of this part of ISO 10555, the fol-
cation.
lowing definitions apply.
lt does not apply to intravascular catheter accessories,
3.1 intravascular catheter: Tubular device, Single
which will be covered by a separate Standard.
or multilumen, designed to be partially or totally in-
serted or implanted into the cardiovascular System for
diagnostic and/or therapeutic purposes.
2 Normative references
3.2 distal end: End of the catheter inserted furthest
into the Patient.
The following Standards contain provisions which,
through reference in this text, constitute provisions
3.3 proximal end; access end: End of the catheter
of this part of ISO 10555. At the time of publication,
to which connection tan be made.
the editions indicated were valid. All Standards are
subject to revision, and Parties to agreements based 3.4 hub: Connector(s) at the proximal end of the
on this part of ISO 10555 are encouraged to investi- catheter which may either be integral with the
gate the possibility of applying the most recent edi-
catheter or be capable of being securely fitted to the
tions of the Standards indicated below. Members of
proximal end of the catheter.
IEC and ISO maintain registers of currently valid
International Standards. 3.5 effective length, I: Length of the catheter that
tan be inserted into the body. (See figure 1.)
ISO 594-1: 1986, Conical fittings with a 6 % (Luer) ta-
3.6 outside diameter: Maximum diameter of that
per for syringes, needles and certain other medical
patt of the catheter that tan be inserted into the
equipmen t - Part 7: General requiremen ts.
vessel.
ISO 594-2: 1991, Conical fittings with a 6 % (Luer) ta-
per for syringes, needles and certain other medica% 3.7 junction: That Portion of the catheter that joins
equipmen t - Part 2: Lack fittings. one tube to multiple tubes.
ISO 10555=1:1995(E)
/ /-
I I( fi
f (-
: ?- l/
/- 3
/
\ :,
\
I I
G== 1
Z = effective length
1. catheter hub
2. catheter strain reinforcement
3. length mark
4. junction
Figure 1 - Examples of effective length of catheters

0 ISO ISO 10555=1:1995(E)
4 Requirements
Table 1 - Forte at break of catheter test pieces
4.1 General
Smallest outside
Minimum forte at break
diameter of tubular
The catheter shall have been sterilized by a validated
Portion of test piece
method, and shall comp ly wit h 4.2 to 4.7 in the sterile
condition.
mm N
NOTE 1 See ISO 11134, ISO 11135 and ISO 11137 for > 0,55 < 0,75 3
appropriate methods of sterilization.
2 0,75 < 1,15 5
IO
> 1,15 < 1,85
4.2 Biocompatibility
> 1,85 15
The catheter shall be free from biological hazard.
NOTE - This part of ISO 10555 does not specify re-
See ISO 10993-1 for the selection of appropriate
NOTE 2
quirements for forte at break for tubing of less than
test methods.
0,55 mm outside diameter.
4.3 Surface
4.7 Hubs
When examined by normal or corrected to normal
Vision with x 2,5 magnification, the external surface
If the catheter is supplied with either an integral or a
of the effective length of the catheter shall appear
separate hub, it shall be a female hub and shall com-
free from extraneous matter.
ply with ISO 594-1 and ISO 594-2.
The external surface of the effective length of the
catheter, including the distal end, should be free from
process and surface defects and should Cause mini-
5 Designation of nominal size
mum trauma to vessels during use.
The nominal size of the catheter shall be designated
If the catheter is lubricated, the Iubricant should not
as specified in 5.1 and 5.2.
be visible as drops of fluid on the external surface
when the catheter is examined under normal or cor-
5.1 Outside diameter
rected to normal Vision.
Unless otherwise specified in the International Stan-
4.4 Corrosion resistance
dard for a particular type of catheter, the outside di-
ameter shall be expressed in millimetres, rounded
When tested in accordance with the method given in
upwards to the nearest 0,05 mm for outside diam-
annex A, metallic components of the catheter shall
eters of less than 2 mm, or to the nearest 0,l mm for
show no signs of corrosion.
outside diameters of 2 mm and greater.
4.5 Forte at break
5.2 Effective length
When tested in accordance with the method given ir
The effective length shall be expressed in a w iole
annex B, the forte at break of each test piece shal
number of millimetres for effective lengths of ess
be as given in table 1.
than 99 mm and in either a whole number of milli-
metres or a whole number of centimetres for effec-
4.6 Freedom from leakage
tive lengths of 99 mm and greater.
4.6.1 The hub or connection fitting assembly or any
other part of the catheter shall not leak liquid when
6 Information to be supplied by
tested in accordance with the method given in
annex C.
manufacturer
4.6.2 Air shall not leak into the hub assembly during The manufacturer shall supply at least the following
aspiration when tested in accordance with the information. All dimensions given shall be expressed
method given in annex D. in SI units of measurement.
ISO 10555=1:1995(E)
0 ISO
Units of other measurement Systems may additionally g) any special storage and handling instructions;
be used.
h) indication of sterility;
a) description of the
product;
method of sterilization;
i)
b) outside diameter;
.
indication for Single use;
1)
c) effective length;
k) any known Chemical and/or physical incompati-
d)
name or tradename and address of manufacturer; bilities with substances likely to be used with the
catheter;
e) lot designation;
1) instructions for use and warnings, as appropriate.
f) expiry date or use by date;

ISO 1055501:1995(E)
Annex A
(normative)
Test method for corrosion resistance
move the test specimen and immerse it in boiling
A.l Principle
distilled water (A.2.2) for 30 min. Allow the water and
the test specimen to cool to 37 “C, and maintain them
The catheter is immersed in sodium chloride Solution,
at this temperature for 48 h. Remove the test speci-
then in boiling distilled water, and afterwards exam-
men and allow it to dry at room temperature. Disas-
ined visually for evidente of corrosion.
semble specimens that have two or more
components which are intended to be separable in
A.2 Reagents
use. DO not Strip away or tut open any coatings on
metallic components. Inspect the specimen visually
A.2.1 Saline Solution, comprising a Solution of
for signs of corrosion.
analytical reagent grade sodium chloride in freshly
prepared distilled wa
...