EN 13867:2002+A1:2009

Concentrates for haemodialysis and related therapies

This European Standard specifies requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates.
This European standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies.
This European standard does not apply to dialysing fluid regeneration systems.

Konzentrate für die Hämodialyse und verwandte Therapien

Diese Europäische Norm legt Anforderungen für trockene und flüssige Konzentrate fest, die für die
Verdünnung zur Verwendung als Dialysierflüssigkeit in der Hämodialyse oder ähnlichen Therapien bestimmt
sind. Sie behandelt die chemische und mikrobiologische Qualität und Reinheit, die Handhabung und
Kennzeichnung der Konzentrate, die Anforderungen an Behälter und die Prüfungen zur chemischen und
mikrobiologischen Überwachung der Inhaltsstoffe sowie die Qualität solcher Konzentrate.
Diese Europäische Norm behandelt nicht die endgültige Mischung und die Anwendung dieser Konzentrate
oder das im Zusammenhang mit der Hämodialyse und ähnlichen Therapien verwendete aufbereitete Wasser.
Diese Europäische Norm gilt nicht für Systeme zur Regeneration von Dialysierflüssigkeiten.

Concentrés pour hémodialyse et thérapies associées

La présente Norme européenne fixe des exigences applicables aux concentrés en poudre et liquides à diluer pour
être utilisés comme liquides de dialyse pour l’hémodialyse ou les thérapeutiques voisines. Elle traite de la qualité et
de la pureté chimique et microbiologique, du stockage et de l’étiquetage des concentrés ainsi que des exigences
relatives aux cubitainers et des essais à effectuer pour contrôler la teneur et la qualité chimique et microbiologique
de ces concentrés.
La présente Norme européenne ne traite ni des mélanges finaux, ni de l’utilisation de ces concentrés, ni de l’eau
traitée utilisée pour l’hémodialyse et les thérapeutiques voisines.
Elle ne s’applique pas aux systèmes de régénération du liquide de dialyse.

Koncentrati za hemodializo in podobne terapije

General Information

• Status: Withdrawn
• Publication Date: 16-Jun-2009
• Withdrawal Date: 13-Apr-2025
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 02-Dec-2015
• Completion Date: 14-Apr-2025
• 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
• Directive: 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+A1:2009 - Concentrates for haemodialysis and related therapies

Relations

• Merged From: EN 13867:2002/prA1 - Concentrates for haemodialysis and related therapies
• Effective Date: 29-Apr-2009
• Merged From: EN 13867:2002 - Concentrates for haemodialysis and related therapies
• Effective Date: 29-Apr-2009
• Replaced By: EN ISO 13958:2015 - Concentrates for haemodialysis and related therapies (ISO 13958:2014)
• Effective Date: 09-Dec-2015

Standards Content (Sample)

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.
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 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
...