EN 13867:2002+A1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Koncentrati za hemodializo in podobne terapijeKonzentrate für die Hämodialyse und verwandte TherapienConcentrés pour hémodialyse et thérapies associéesConcentrates for haemodialysis and related therapies11.120.99Drugi standardi v zvezi s farmacijoOther standards related to pharmaceuticsICS:Ta slovenski standard je istoveten z:EN 13867:2002+A1:2009SIST EN 13867:2003+A1:2009en,fr,de01-oktober-2009SIST EN 13867:2003+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13867:2002+A1
June 2009 ICS 11.040.20; 11.120.99 Supersedes EN 13867:2002English Version
Concentrates for haemodialysis and related therapies
Concentrés pour hémodialyse et thérapies associées
Konzentrate für die Hämodialyse und verwandte TherapienThis European Standard was approved by CEN on 30 December 2001 and includes Amendment 1 approved by CEN on 16 May 2009.
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 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 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.
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B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13867:2002+A1:2009: ESIST EN 13867:2003+A1:2009

Examples of analytical methods . 10Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC "Medical Devices""""" . 11Annex ZB (informative)
A-deviations . 13Bibliography . 14 SIST EN 13867:2003+A1:2009

This European standard does not apply to dialysing fluid regeneration systems. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 556,
Sterilization of medical devices – Requirements for medical devices to be labelled “Sterile” EN 980, Graphical symbols for use in the labelling of medical devices EN 1174-1, Sterilization of medical devices – Estimation of the population of micro-organisms on product – Part 1: Requirements EN 1174-2, Sterilization of medical devices - Estimation of the population of micro-organisms on product – Part 2: Guidance EN 1174-3, Sterilization of medical devices – Estimation of the population of micro-organisms on product – Part 3: Guide to the methods for validation of microbiological techniques European Pharmacopoeia 3rd edition: 1999 (including supplements 2000 and 2001)
3 Terms and definitions For the purpose of this European standard, the following terms and definitions apply: 3.1
acetate dialysing fluid dialysing fluid without bicarbonate, using acetate as a
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