EN ISO 11070:1999

Sterile single-use intravascular catheter introducers (ISO 11070:1998)

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.

Einführinstrumente für intravaskuläre Katheter zur einmaligen Verwendung (ISO 11070:1998)

Diese Internationale Norm legt Anforderungen an Einführkanülen, Einführkatheter, Führungshülsen, Führungsdrähte und Dilatatoren fest, die steril geliefert werden und zur einmaligen Verwendung mit intravaskulären Kathetern nach ISO 10555 bestimmt sind. Anmerkung: Eine Anleitung für die Werkstoffauswahl und für die Gestaltung von Zubehörinstrumenten wird in Anhang A gegeben.

Introducteurs de cathéters intravasculaires stériles, non réutilisables (ISO 11070:1998)

La présente Norme internationale spécifie les prescriptions relatives aux aiguilles de l'introducteur, cathéters de l'introducteur et introducteurs gaines, guides et dilatateurs fournis dans des conditions stériles, non réutilisables, pour cathéters intravasculaires spécifiés dans l'ISO 10555.
NOTE L'annexe A donne des indications sur les matériaux et la conception des dispositifs accessoires.

Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:1998)

General Information

• Status: Withdrawn
• Publication Date: 20-Apr-1999
• Withdrawal Date: 11-Nov-2014
• 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
• Completion Date: 12-Nov-2014
• Ref Project: SIST EN ISO 11070:2000 - Sterile single-use intravascular catheter introducers (ISO 11070:1998)

Relations

• Replaced By: EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
• Effective Date: 16-Nov-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11070:2000
01-januar-2000
Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:1998)
Sterile single-use intravascular catheter introducers (ISO 11070:1998)
Einführinstrumente für intravaskuläre Katheter zur einmaligen Verwendung (ISO
11070:1998)
Introducteurs de cathéters intravasculaires stériles, non réutilisables (ISO 11070:1998)
Ta slovenski standard je istoveten z: EN ISO 11070:1999
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11070:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11070:2000

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SIST EN ISO 11070:2000

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SIST EN ISO 11070:2000

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SIST EN ISO 11070:2000

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SIST EN ISO 11070:2000

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SIST EN ISO 11070:2000
INTERNATIONAL ISO
STANDARD 11070
First edition
1998-05-01
Sterile single-use intravascular catheter
introducers
Introducteurs de cathéters intravasculaires stériles, non réutilisables
A
Reference number
ISO 11070:1998(E)

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SIST EN ISO 11070:2000
ISO 11070:1998(E)
Page
Contents
1 Scope 1
2 Normative references 1
3 Definitions 1
4 General requirements 4
5 Additional requirements for introducer needles 5
6 Additional requirements for introducer catheters 6
7 Additional requirements for sheath introducers 7
8 Additional requirements for guide wires 8
9 Additional requirements for dilators 9
10 Additional requirements for kits containing combinations of devices
specified in this International Standard 10
Annexes
A Guidance on materials and design 11
B Test for corrosion resistance 12
C Determination of force at break of introducer catheters, sheath introducers and dilators 13
D Test for liquid leakage from sheath introducers under pressure 14
E Test for liquid leakage through haemostasis valves of sheath introducers 16
F Test for fracture of guide wires 17
G Test for resistance of guide wires to damage by flexing 19
H Test for strength of union of core wire and coil of guide wire and union of coil and safety wire 21
J  Bibliography 23
©  ISO 1998
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]
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii

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SIST EN ISO 11070:2000
©
ISO ISO 11070:1998(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.
International Standard ISO 11070 was prepared by Technical Committee ISO/TC 84, Medical devices for injection,
Subcommittee SC 1, Syringes, needles and intravascular catheters for single use.
Annexes B, C, D, E, F, G, and H form an integral part of this International Standard. Annexes A and J are for
information only.
iii

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SIST EN ISO 11070:2000

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SIST EN ISO 11070:2000
©
INTERNATIONAL STANDARD  ISO ISO 11070:1998(E)
Sterile, single-use intravascular catheter introducers
1  Scope
This International Standard specifies requirements for introducer needles, introducer catheters, sheath introducers,
guide wires and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular
catheters specified in ISO 10555.
NOTE - Guidance on materials and design of accessory devices is given in annex A.
2  Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
Inte
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