SIST EN ISO 10555-3:2000

SLOVENSKI STANDARD
SIST EN ISO 10555-3:2000
01-januar-2000
Sterilni žilni katetri za enkratno uporabo - 3. del: Osrednji venski katetri (ISO 10555
-3:1996)
Sterile, single-use intravascular catheters - Part 3: Central venous catheters (ISO 10555-
3:1996)
Sterile intravaskuläre Katheter zur einmaligen Verwendung - Teil 3: Zentrale venöse
Katheter (ISO 10555-3:1996)
Cathéters intravasculaires stériles, non réutilisables - Partie 3: Cathéters centraux
veineux (ISO 10555-3:1996)
Ta slovenski standard je istoveten z: EN ISO 10555-3:1997
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-3:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10555-3:2000

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SIST EN ISO 10555-3:2000

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SIST EN ISO 10555-3:2000

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SIST EN ISO 10555-3:2000

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SIST EN ISO 10555-3:2000

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SIST EN ISO 10555-3:2000
INTERNATIONAL
IS0
STANDARD -
10555-3
First edition
1996-06-15
Sterile, single-use intravascular catheters -
Part 3:
Central venous catheters
Ca th6 ters in travasculaires s t&riles, non r&tilisables -
Partie 3: Ca th&ers centraux veineux
Reference number
IS0 10555-3:1996(E)

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SIST EN ISO 10555-3:2000
Foreword
IS0 (the International Organization for Standardization) is a worldwide fed-
eration of national standards bodies (IS0 member bodies). The work of
preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be rep-
resented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. IS0 col-
laborates closely with the International Electrotechnical Commission (IEC)
on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are cir-
culated 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 IS0 10555-3 was prepared by Technical Committee
lSO/TC 84, Medical devices for injections, Subcommittee SC 1, Syringes,
needles and intravascular catheters for single use.
IS0 10555 consists of the following parts, under the general title Sterile,
single-use intravascular catheters:
Part I: General requirements
- Part 2: Angiographic catheters
- Part 3: Central venous catheters
Part 4: Balloon dilatation catheters
Part 5: Over-needle peripheral catheters
Annex A forms an integral part of this part of IS0 10555. Annex B is for
information only.
0 IS0 1996
All rights reserved. Unless otherwise specified, no part of this publication may be repro-
duced or utilized in any form or by any means, electronic or mechanical, including photo-
copying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii

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SIST EN ISO 10555-3:2000
INTERNATIONAL STANDARD @ Iso IS0 10555=3:1996(E)
Sterile, single-use intravascular catheters -
Part 3:
Central venous catheters
NOTE 2 The catheter may have a fixation system which is
1 Scope
part of the device.
This part of IS0 10555 specifies requirements for cen-
tral venous catheters supplied in the sterile condition,
and intended for single use.
4 Requirements
NOTE 1 Attention is drawn to IS0 11070, which specifies
4.1 General
requirements for accessory devices for use with intra-
vascular catheters.
Catheters shall comply with IS0 10555-1, except for
the force at break (see IS0 10555-I :1995, subclause
4.5), for which the requirements of subclause 4.7 of
this part of IS0 10555 shall apply.
2 Normative references
The following standards contain provisions which,
4.2 Radio-detectability
through reference in this text, constitute provisions of
this part of IS0 10555. At the time of publication, the
The catheter shall be radio-detectable.
editions indicated were valid. All standards are subject
to revision, and parties to agreements based on this NOTE 3 At the time of publication of this part of
IS0 10555, there is no acceptable, validated test method to
part of IS0 10555 are encouraged to investigate the
determine radio-detectability. An approved test method for
possibility of applying the most recent editions of the
producing a value of radio-detectability will be established.
standards indicated below. Members of IEC and IS0
Until that time, a manufacturer may label his product “radio-
maintain registers of currently valid International Stan-
opaque” provided he can support this claim by demonstrat-
dards.
ing that he has an appropriate method for showing radio-
opacity.
IS0 594-l : 1986, Conical fittings with a 6 % (Luer)
taper for syringes, needles and certain other medical
equipment - Part 1: General requirements.
4.3 Tip configuration
IS0 1055
...