EN ISO 11070:2014

Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)

ISO 11070:2014 specifies requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters.

Sterile intravaskuläre Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen Verwendung (ISO 11070:2014)

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 ist in Anhang A gegeben.

Introducteurs, dilatateurs et guides intravasculaires stériles non réutilisables (ISO 11070:2014)

L'ISO 11070:2014 spécifie les exigences relatives aux aiguilles d'introducteurs, cathéters d'introducteurs et introducteurs gaines, guides et dilatateurs fournis dans des conditions stériles, non réutilisables, destinés à être utilisés avec des cathéters intravasculaires.

Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:2014)

Ta mednarodni standard določa zahteve za nastavke za uvedbo igel, nastavke za uvedbo katetra, nastavke za uvedbo tulcev, vodilne žice in dilatorje, ki so dobavljeni v sterilnem stanju in namenjeni za enkratno uporabo skupaj z žilnimi katetri iz standarda ISO 10555-1. OPOMBA Navodila za material in načrtovanje dodatnih naprav so navedena v dodatku A.

General Information

• Status: Published
• Publication Date: 11-Nov-2014
• Withdrawal Date: 30-May-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Nov-2014
• Completion Date: 12-Nov-2014
• Ref Project: SIST EN ISO 11070:2015 - Sterile, single-use intravascular catheter introducers (ISO 11070:2014)

Relations

• Replaces: EN ISO 11070:1999 - Sterile single-use intravascular catheter introducers (ISO 11070:1998)
• Effective Date: 16-Nov-2014
• Amended By: EN ISO 11070:2014/A1:2018 - Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)
• Effective Date: 21-Dec-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11070:2015
01-marec-2015
1DGRPHãþD
SIST EN ISO 11070:2000
Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:2014)
Sterile, single-use intravascular catheter introducers (ISO 11070:2014)
Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen
Verwendung (ISO 11070:2014)
Introducteurs de cathéters intravasculaires stériles, non réutilisables (ISO 11070:2014)
Ta slovenski standard je istoveten z: EN ISO 11070:2014
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11070:2015 de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11070:2015

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SIST EN ISO 11070:2015

EUROPEAN STANDARD
EN ISO 11070

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2014
ICS 11.040.25 Supersedes EN ISO 11070:1999
English Version
Sterile single-use intravascular introducers, dilators and
guidewires (ISO 11070:2014)
Introducteurs, dilatateurs et guides intravasculaires stériles Sterile Einführungsinstrumente, Dilatatoren und
non réutilisables (ISO 11070:2014) Führungsdrähte zur einmaligen Verwendung (ISO
11070:2014)
This European Standard was approved by CEN on 30 August 2014.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11070:2014 E
worldwide for CEN national Members.

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SIST EN ISO 11070:2015
EN ISO 11070:2014 (E)
Contents page
Foreword .3
2

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SIST EN ISO 11070:2015
EN ISO 11070:2014 (E)
Foreword
This document (EN ISO 11070:2014) has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and catheters” in collaboration with 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 May 2015, and conflicting national standards shall be withdrawn at the
latest by May 2015.
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 11070:1999.
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, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11070:2014 has been approved by CEN as EN ISO 11070:2014 without any modification.


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SIST EN ISO 11070:2015

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SIST EN ISO 11070:2015
INTERNATIONAL ISO
STANDARD 11070
Second edition
2014-11-01
Sterile single-use intravascular
introducers, dilators and guidewires
Introducteurs, dilatateurs et guides intravasculaires stériles non
réut
...