EN ISO 10555-1:1996/A1:1999

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1996/AM1:1999)

To amend EN ISO 10555-1 so as to include requirements for hydratable catheters.

Sterile intravaskuläre Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:1996/AM1:1999)

Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales (ISO 10555-1:1996/AM1:1999)

Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:1996/AM1:1999)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-1999
• Withdrawal Date: 12-May-2009
• 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: 13-May-2009
• Completion Date: 13-May-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10555-1:2000/A1:2000 - Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1996/AM1:1999)

Relations

• Amends: EN ISO 10555-1:1996 - Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 10555-1:2009 - Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
• Effective Date: 20-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10555-1:2000/A1:2000
01-julij-2000
Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-
1:1996/AM1:1999)
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-
1:1996/AM1:1999)
Sterile intravaskuläre Katheter zur einmaligen Verwendung - Teil 1: Allgemeine
Anforderungen (ISO 10555-1:1996/AM1:1999)
Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales
(ISO 10555-1:1996/AM1:1999)
Ta slovenski standard je istoveten z: EN ISO 10555-1:1996/A1:1999
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-1:2000/A1:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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ISO
INTERNATIONAL
10555-1
STANDARD
First edition
1995-06-15
Amendment 1
1999-07-15
Sterile, single-use intravascular
catheters —
Part 1:
General requirements
AMENDMENT 1
Cathéters intravasculaires stériles, non réutilisables —
Partie 1: Prescriptions générales
AMENDEMENT 1
A
Reference number
ISO 10555-1:1995/Amd.1:1999(E)

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ISO 10555-1:1995/Amd.1:1999(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.
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.
Amendment 1 to International Standard ISO 10555-1 was prepared by Technical Committee ISO/TC 84, Medical
devices for injections, Subcommittee SC 1, Syringes, needles and intravascular catheters for single use.
The purpose of this amendment is to add to ISO 10555-1 general requirements for hydratable catheters.
©  ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet [e-mail]
Printed in Switzerland
ii

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© ISO
ISO 10555-1:1995/Amd.1:1999(E)
Sterile, single-use intravascular catheters —
Part 1:
General requirements
AMENDMENT 1
Page 1
Clause 3  Definitions
Delete existing definitions for 3.5 and 3.6, and substitute the following definitions:
3.5  effective length, l: Length of the catheter, or pre- and post-hydration lengths of hydratable catheters, that
can be inserted into the body (see figure 1).
3.6  outside diameter: Maximum diameter o
...