EN 13867:2002+A1:2009
(Main)Concentrates for haemodialysis and related therapies
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
Relations
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 buffer NOTE Acetate dialysing fluid is generally produced from a single concentrate.
3.2
batch system system in which water and concentrate(s) are mixed in one tank and the resulting fluid used for haemodialysis or related therapies 3.3
bicarbonate dialysing fluid dialysing fluid containing physiological or higher concentrations of bicarbonate as buffer NOTE Bicarbonate dialysing fluid is produced by mixing two or more concentrates. SIST EN 13867:2003+A1:2009
dialysing fluid
dialysis fluid dialysate fluid which is intended to exchange solutes with blood during haemodialysis or haemodiafiltration
3.5
dialysing fluid without buffer dialysis fluid without basic
agents using the buffer in the substitution fluid 3.6
proportioning system system for continuous mixing of water and concentrate in order to obtain dialysing fluid and/or substitution fluid 4 Requirements 4.1 Concentration limits All components identified in the labelling shall be present within ± 5% of the stated concentration, with the exception of sodium which shall be present within ± 2.5% of the stated concentration for the duration of any specified shelf-life. A list of examples of analytical techniques is given in annex A. 4.2 Water quality
When tested as described in 6.1, the quality of water used in the manufacture of liquid concentrates shall be in accordance with the requirements of the Monograph 1167 of the European Pharmacopoeia: 1999. 4.3 pH range When the concentrate is diluted in accordance with the manufacturer’s instructions and tested as described in 6.2, the ready-to-use dialysing fluid shall have a pH in the range of 6,0 to 8,0 or, in the case of dialysing fluid without buffer, in the range of 5,0 to 8,0.
4.4 Chemical quality Raw materials used for the manufacture of concentrates shall meet the technical requirements of the relevant Monographs of the European Pharmacopoeia 1999.
The aluminium content of the concentrate shall not exceed 100 µg/l. 4.5 Manufacturing process (filtration) During the manufacturing process for dialysis concentrates, liquid acid or acetate concentrates shall be filtered through a filter of pore size 1,2 µm or finer, that does not release fibres and that does not contain material of known potential for human injury.
Liquid bicarbonate concentrates shall be filtered through a similar filter of pore size 0,22 µm or finer if purified water according to the European Pharmacopoeia: 1999 is used, or 0,45 µm or finer if water for injection is used. The test for compliance is given in 6.3. 4.6 Containers When tested as described in 6.4, containers, including the closures, shall not int
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