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CEN

EN 13867:2002/prA1

(Amendment)

Concentrates for haemodialysis and related therapies

Concentrates for haemodialysis and related therapies

Konzentrate für die Hämodialyse und verwandte Therapien

Concentrés pour hémodialyse et thérapies associées

Koncentrati za hemodializo in podobne terapije

General Information

Status
Not Published
ICS
11.040.20 - Transfusion, infusion and injection equipment
11.120.99 - Other standards related to pharmaceutics
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
15-Apr-2009
Completion Date
15-Apr-2009
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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 13867:2003/kprA1:2009 - Concentrates for haemodialysis and related therapies

Relations

Merged Into
EN 13867:2002+A1:2009 - Concentrates for haemodialysis and related therapies
Effective Date
29-Apr-2009
Amends
EN 13867:2002 - Concentrates for haemodialysis and related therapies
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
01-april-2009
Koncentrati za hemodializo in podobne terapije
Concentrates for haemodialysis and related therapies
Konzentrate für die Hämodialyse und verwandte Therapien
Concentrés pour hémodialyse et thérapies associées
Ta slovenski standard je istoveten z: EN 13867:2002/prA1
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 13867:2002
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 11.120.99
English Version
Concentrates for haemodialysis and related therapies
Concentrés pour hémodialyse et thérapies associées Konzentrate für die Hämodialyse und verwandte Therapien
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 205.
This draft amendment A1, if approved, will modify the European Standard EN 13867:2002. If this draft becomes an amendment, 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.
This draft amendment was established by CEN 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13867:2002/prA1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
1 Modification to Annex ZA .
...

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