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)

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

General Information

Status
Published
Public Enquiry End Date
09-Feb-2018
Publication Date
23-Aug-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
16-Jul-2018
Due Date
20-Sep-2018
Completion Date
24-Aug-2018

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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

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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.
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SIST EN ISO 11070:2015/A
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