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CEN

EN ISO 11070:2014/A1:2018

(Amendment)

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Sterile intravaskuläre Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen Verwendung - Änderung 1 (ISO 11070:2014/Amd 1:2018)

Introducteurs, dilatateurs et guides intravasculaires stériles non réutilisables - Amendement 1 (ISO 11070:2014/Amd 1:2018)

Sterilni žilni instrumenti za enkratno uporabo - Dopolnilo A1 (ISO 11070:2014/Amd 1:2018)

General Information

Status
Published
Publication Date
03-Jul-2018
Withdrawal Date
30-Jan-2019
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
04-Jul-2018
Completion Date
04-Jul-2018
Ref Project
SIST EN ISO 11070:2015/A1:2018 - Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Relations

Amends
EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
Effective Date
21-Dec-2016

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11070:2015/A1:2018
01-september-2018
Sterilni žilni instrumenti za enkratno uporabo - Dopolnilo A1 (ISO 11070:2014/Amd
1:2018)
Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO
11070:2014/Amd 1:2018)
Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen
Verwendung - Änderung 1 (ISO 11070:2014/Amd 1:2018)
Introducteurs, dilatateurs et guides intravasculaires stériles non réutilisables -
Amendement 1 (ISO 11070:2014/Amd 1:2018)
Ta slovenski standard je istoveten z: EN ISO 11070:2014/A1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11070:2015/A1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11070:2015/A1:2018

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SIST EN ISO 11070:2015/A1:2018


EN ISO 11070:2014/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2018
EUROPÄISCHE NORM
ICS 11.040.25
English Version

Sterile single-use intravascular introducers, dilators and
guidewires - Amendment 1 (ISO 11070:2014/Amd
1:2018)
Introducteurs, dilatateurs et guides intravasculaires Sterile Einführungsinstrumente, Dilatatoren und
stériles non réutilisables - Amendement 1 (ISO Führungsdrähte zur einmaligen Verwendung -
11070:2014/Amd 1:2018) Änderung 1 (ISO 11070:2014/Amd 1:2018)
This amendment A1 modifies the European Standard EN ISO 11070:2014; it was approved by CEN on 3 July 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11070:2014/A1:2018 E
worldwide for CEN national Members.

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SIST EN ISO 11070:2015/A1:2018
EN ISO 11070:2014/A1:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11070:2015/A1:2018
EN ISO 11070:2014/A1:2018 (E)
European foreword
This document (EN ISO 11070:2014/A1:2018) 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 January 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1617:1997.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11070:2014/Amd 1:2018 has been approved by CEN as EN ISO 11070:2014/A1:2018
without any modification.
3

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