EN ISO 10555-2:1997

Sterile, single-use intravascular catheters - Part 2: Angiographic catheters (ISO 10555-2:1996)

Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI will probably go to a PV procedure. ++ Target dates agreed under Resolution BTS3 H C4/1992.

Sterile intravaskuläre Katheter zur einmaligen Verwendung - Teil 2: Angiographiekatheter (ISO 10555-2:1996)

Dieser Teil der ISO 10555 legt Anforderungen für Angiographiekatheter fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind.

Cathéters intravasculaires stériles, non réutilisables - Partie 2: Cathéters angiographiques (ISO 10555-2:1996)

La présente partie de l'ISO 10555 fixe les prescriptions relatives aux cathéters angiographiques non réutilisables, fournis stériles.
NOTE 1 L'attention est attirée sur l'ISO 11070, qui fixe les prescriptions relatives aux dispositifs accessoires pour utilisation avec les cathéters intravasculaires.

Sterilni žilni katetri za enkratno uporabo - 2. del: Angiografski katetri (ISO 10555-2:1996)

General Information

• Status: Withdrawn
• Publication Date: 22-Jul-1997
• Withdrawal Date: 17-Sep-2013
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 6 - Catheters and enteral feeding tubes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 18-Sep-2013
• Completion Date: 18-Sep-2013
• Ref Project: SIST EN ISO 10555-2:2000 - Sterile, single-use intravascular catheters - Part 2: Angiographic catheters (ISO 10555-2:1996)

Relations

• Replaced By: EN ISO 10555-1:2013 - Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2014-01-15)
• Effective Date: 30-Oct-2013
• Corrected By: EN ISO 10555-2:1997/AC:2002 - Sterile, single-use intravascular catheters - Part 2: Angiographic catheters (ISO 10555-2:1996/Cor.1:2002)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2000
Sterilni žilni katetri za enkratno uporabo - 2. del: Angiografski katetri (ISO 10555-
2:1996)
Sterile, single-use intravascular catheters - Part 2: Angiographic catheters (ISO 10555-
2:1996)
Sterile intravaskuläre Katheter zur einmaligen Verwendung - Teil 2:
Angiographiekatheter (ISO 10555-2:1996)
Cathéters intravasculaires stériles, non réutilisables - Partie 2: Cathéters
angiographiques (ISO 10555-2:1996)
Ta slovenski standard je istoveten z: EN ISO 10555-2:1997
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.

INTERNATIONAL
IS0
STANDARD
10555-2
First edition
1996-06-15
Sterile, single-use intravascular catheters -
Part 2:
Angiographic catheters
Cathdters intravasculaires st&iles, non rdtilisables -
Partie 2: Catheters angiographiques
Reference number
IS0 10555-2:1996(E)
IS0 10555=2:1996(E)
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 10555-2 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-121 1G eneve 20 l Switzerland
Printed in Switzerland
ii
INTERNATIONAL STANDARD @ IS0 IS0 10555=2:1996(E)
Sterile, single-use intravascular catheters -
Part 2:
Angiographic catheters
3.2 distal end configuration: Shape of the catheter
1 Scope
which is designed to facilitate its manual manipulation
through the cardiovascular system and the placement
This part of IS0 10555 specifies requirements for
of the tip in the location chosen for the angiographic
angiographic catheters supplied in the sterile con-
procedures.
dition, and intended for single use.
NOTE 1 Attention is drawn to IS0 11070, which specifies
requirements for accessory devices for use with intravascu-
lar catheters.
4 Requirements
4.1 General
2 Normative reference
Unless otherwise specified in this part of IS0 10555,
The following standards contain provisions which,
catheters shall comply with IS0 10555-I.
through reference in this text, constitute provisions of
this part of IS0 10555. At the time of publication, the
edition indicated were valid. All standards are subject
to revision, and parties to agreements based on this 4.2 Radio-detectability
part of IS0 10555 are encouraged to investigate the
possibility of applying the most recent editions of the
The catheter shall be radio-detectable.
standards indicated below. Members of IEC and IS0
maintain registers of currently valid International Stan- NOTE 2 At the time of publication of this part of
IS0 10555, there is no acceptable, validated test method to
dards.
determine radio-detectability. An approved test method for
producing a value of radio-detectability will be established.
IS0 10555-I : 1995, Sterile, single-use intravascular
Until that time, a manufacturer may label his product “radio-
catheters - Part I: General requirements.
opaque” provided he can support this claim by demonstrat-
ing that he has an appropriate method for showing radio-
opacity.
3 Definitions
For the purposes of this part of IS0 10555, the defi- 4.3 Designation of nominal size
nitions given in IS0 10555-I and the following defi-
nitions apply.
The nominal size of the catheter shall be designated in
accordance with IS0 10555-I and also by the diam-
eter of the largest guidewire that can be used with the
3.1 angiog
...