EN 13867:2002
(Main)Concentrates for haemodialysis and related therapies
Concentrates for haemodialysis and related therapies
This European Standard applies to 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 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
Anwendungsbereich
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 s'applique aux concentrés secs et liquides à diluer pour être utilisés comme liquides de dialyse pour l'hémodialyse ou les thérapies associées. Elle traite de la qualité et de la pureté chimique et microbiologique, de la manutention et de l'étiquetage des concentrés et prescrit les exigences relatives aux conteneurs et les essais à effectuer pour contrôler la teneur et la qualité chimique et microbiologique de ces concentrés. La présente norme ne traite ni des mélanges finaux, ni de l'utilisation de ces concentrés, ni de l'eau traitée utilisée pour l'hémodialyse et les thérapies associées.
Koncentrati za hemodializo in podobne terapije
General Information
- Status
- Withdrawn
- Publication Date
- 22-Oct-2002
- Withdrawal Date
- 16-Jun-2009
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 17-Jun-2009
- Completion Date
- 17-Jun-2009
Relations
- Effective Date
- 29-Apr-2009
- Effective Date
- 22-Dec-2008
Frequently Asked Questions
EN 13867:2002 is a standard published by the European Committee for Standardization (CEN). Its full title is "Concentrates for haemodialysis and related therapies". This standard covers: This European Standard applies to 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 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.
This European Standard applies to 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 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.
EN 13867:2002 is classified under the following ICS (International Classification for Standards) categories: 11.120.99 - Other standards related to pharmaceutics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13867:2002 has the following relationships with other standards: It is inter standard links to EN 13867:2002+A1:2009, EN 13867:2002/prA1. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13867:2002 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2003
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
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
EN 13867
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2002
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 European Standard was approved by CEN on 30 December 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13867:2002 E
worldwide for CEN national Members.
Contents
Foreword. 3
Introduction . 4
1 Scope. 5
2 Normative references . 5
3 Terms and definitions. 5
4 Requirements . 6
4.1 Concentration limits . 6
4.2 Water quality. 6
4.3 pH range. 6
4.4 Chemical quality. 6
4.5 Manufacturing process (filtration). 6
4.6 Containers. 6
4.7 Microbiological quality . 6
5 Labelling and documentation requirements . 7
5.1 General. 7
5.2 Information to be given on the concentrate container. 7
5.3 Information to be given on the shipping container, if any. 7
5.4 Information to be given in the accompanying documents. 8
5.5 Colour coding. 8
6 Test methods. 8
6.1 Water quality. 8
6.2 pH. 8
6.3 Manufacturing process (filtration). 8
6.4 Containers. 8
6.5 Microbiological quality . 8
6.5.1 Microbial contamination level. 8
6.5.2 Endotoxin level. 9
6.6 Sterility . 9
Annex A (Informative) Examples of analytical methods. 10
Annex ZA (informative). 11
Clauses of this European Standard addressing Essential Requirements or other provisions of
EU Directives . 11
Annex ZB (Informative) A-deviations. 13
Bibliography . 14
Foreword
This document (EN 13867:2002) has been prepared by Technical Committee CEN /TC 205, "Non-active medical
devices", the secretariat of which is held by BSI.
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 April 2003, and conflicting national standards shall be withdrawn at the latest by
April 2003.
For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.
For A-deviations, see annex ZB.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive(s).
Annexes A, ZA and ZB are for information only.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this document: Austria, Belgium, the Czech Republic, Denmark, Finland, France,
Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom.
Introduction
Dialysing fluids contain electrolytes in concentrations approaching that of the composition of
normal extra-cellular body fluid. They can also contain non-electrolytes such as dextrose. Dialysing
fluid quality plays a key role in the safety and biocompatibility of the dialysis treatment. Because of
the large volumes employed, dialysing fluids are generally prepared by diluting concentrates with
water of suitable quality.
The manufacturer of concentrates should utilize raw materials and techniques to minimize
microbial contamination (a low bioburden). The concentrates should be stored in conditions that
assure the maintenance of this low level.
During the dilution and use of these concentrates it is essential to take precautions to minimize any
microbial contamination.
The dialysing fluid is prepared from concentrates manufactured, packaged and labelled according
to this standard, mixed with defined large proportions of water meeting national requirements on
water for dialysis. Operation of water treatment equipment, selection and handling of concentrates
after delivery to the hospital or clinic, and operation of the dialysis equipment are the responsibility
of the dialysis facility.
The properties of the final mixed dialysing fluids are not within the control of concentrate
manufacturers. This standard does not address the important clinical and technical processes
connected with the selection of concentrates and preparation of dialysing fluids. Dialysis professionals
make choices about the various applications (e.g. haemodialysis, haemodiafiltration, haemofiltration)
and it is essential they understand the corresponding risks and the requirements for safety of fluids
used for each therapy.
1 Scope
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.
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 fl
...
The standard EN 13867:2002, titled "Concentrates for haemodialysis and related therapies," serves a critical function in the healthcare sector, particularly concerning the quality and safety of dialysis treatments. The scope of this European Standard encompasses both dry and liquid concentrates intended for dilution and use as dialysing fluids. This clarity in scope ensures that healthcare providers adhere to strict guidelines on the chemical and microbiological aspects crucial for patient safety. One of the significant strengths of this standard lies in its comprehensive approach to quality and purity. By mandating stringent requirements for the chemical and microbiological quality of concentrates, EN 13867:2002 helps to mitigate risks associated with contamination and ensures that the concentrates are safe for patient use. The particular attention to handling and labelling provides additional layers of safety and helps healthcare professionals in maintaining best practices during preparation and administration. Moreover, the standard specifies requirements for containers, which is essential in minimizing the risk of contamination during storage and transport. The inclusion of tests to monitor the chemical and microbiological contents aligns with best practices in quality assurance. These tests ensure that the concentrates meet established safety standards before they are disseminated for clinical use. However, it is vital to note that this standard does not extend to the final mixing and use of the concentrates, nor does it cover the treated water used in connection with haemodialysis and related therapies. This delineation of scope is crucial as it allows for a focused examination of the concentrates themselves, while other standards or practices may govern the later stages of treatment. Overall, EN 13867:2002 is a vital standard that addresses essential aspects of concentrates for haemodialysis and related therapies, affirming its relevance in ensuring high-quality, safe products in the field of renal care. Its robust framework for monitoring and quality assurance makes it indispensable for manufacturers and healthcare providers committed to delivering optimal patient care.
標準EN 13867:2002は、透析液用の乾燥および液体濃縮物に関する欧州標準として、血液透析や関連療法で使用される濃縮物についての厳格なガイドラインを提供しています。この標準の範囲は、化学的および微生物学的な品質と純度、濃縮物の取り扱いおよびラベル表示、容器の要件、さらにその濃縮物の化学的および微生物学的内容や品質を監視するための試験に関するものです。 EN 13867:2002の強みの一つは、濃縮物の扱いと品質に関する詳細な基準を設定している点です。この標準により、衛生的で信頼性の高いダイアリシス療法を実施するための濃縮物が提供され、患者の安全性が確保されることに寄与します。さらに、濃縮物のラベルに関する要件が明確に規定されており、使用者が簡単に理解できる情報を得られることも重要です。 この標準は、特に血液透析や関連療法における濃縮物の重要性に応じて、その関連性も高いと言えます。濃縮物が正確に管理され、適切に使用されることで、透析療法の有効性が向上し、治療を受ける患者への影響が最小限に抑えられます。ただし、EN 13867:2002は、濃縮物の最終混合や使用、透析液再生システムには適用されないため、これらのプロセスにおいては別の基準が必要となります。 全体として、EN 13867:2002は、血液透析や関連療法において必須のガイドラインを提供する標準であり、その化学的および微生物学的な品質を確保するための重要な手段として位置付けられています。
Die Norm EN 13867:2002 ist eine wichtige europäische Standardisierung, die sich auf Konzentrate für die Hämodialyse und verwandte Therapien konzentriert. Der Umfang dieser Norm ist klar definiert und umfasst sowohl trockene als auch flüssige Konzentrate, die zur Verdünnung als Dialyseflüssigkeiten verwendet werden. Ein wesentliches Merkmal dieser Norm ist die umfassende Behandlung der chemischen und mikrobiologischen Qualität sowie Reinheit der Konzentrate. Ein herausragender Aspekt dieser Norm ist die detaillierte Handhabung und Kennzeichnung der Konzentrate. Diese Spezifikationen tragen dazu bei, sicherzustellen, dass die Konzentrate den höchsten Standards entsprechen, was für die Patientensicherheit in der Hämodialyse unerlässlich ist. Die Norm legt auch strenge Anforderungen an die Behälter fest, in denen diese Konzentrate aufbewahrt werden, sowie an die durchzuführenden Tests zur Überwachung der chemischen und mikrobiologischen Inhalte. Diese umfassenden Qualitätskontrollen sind entscheidend für die Effektivität der Hämodialyse und minimieren potenzielle Risiken für die Patienten. Die Relevanz der EN 13867:2002 erstreckt sich über die rein technische Ebene hinaus, da sie auch regulatorische Anforderungen in der medizinischen Forschung und der klinischen Praxis erfüllt. Sie bietet eine solide Grundlage für Hersteller und klinische Einrichtungen, um die Qualität und Sicherheit ihrer Produkte und Dienstleistungen zu gewährleisten. Es ist jedoch zu beachten, dass die Norm nicht die endgültige Mischung und Verwendung dieser Konzentrate sowie die Behandlung von Wasser in der Hämodialyse behandelt. Ebenso sind Regenerationssysteme für Dialyseflüssigkeiten nicht im Anwendungsbereich dieser Norm enthalten, was die spezifische Fokussierung der Norm verdeutlicht. Insgesamt bietet die EN 13867:2002 eine unverzichtbare Richtlinie für alle Akteure im Bereich der Hämodialyse und verwandter Therapien, indem sie ein hohes Maß an Sicherheit und Qualität in der Anwendung von Konzentraten gewährleistet. Die Stärkung der chemischen und mikrobiologischen Standards ist entscheidend für den Schutz von Patienten und die Verbesserung der Behandlungsresultate.
표준 EN 13867:2002는 혈액투석 및 관련 치료에 사용하는 건조 및 액체 농축액에 적용되는 유럽 표준으로, 이러한 농축액의 희석 후 사용을 위한 규정을 제공합니다. 이 표준은 농축액의 화학적 및 미생물학적 품질과 순도, 취급 및 라벨링 요건, 용기의 요구사항, 그리고 농축액의 화학적 및 미생물학적 내용을 모니터링하기 위한 테스트에 대해 다룹니다. 이 표준의 주요 강점은 농축액의 품질 관리를 체계적으로 다루고 있다는 점입니다. 즉, 사용자의 안전을 보장하고, 효과적인 혈액투석 치료를 위한 기본적인 기준을 설정하여 환자에게 최적의 치료 환경을 제공하는 데 큰 기여를 합니다. 화학적 및 미생물학적 품질을 강조하는 점은 의료 분야에서의 신뢰성을 더욱 높여줍니다. 또한, EN 13867:2002는 용기와 라벨에 대한 요구사항을 명확히 하여 사용자가 농축액을 제대로 이해하고 안전하게 사용할 수 있도록 도와줍니다. 그러나 이 표준은 혈액투석 농축액의 최종 혼합 및 사용, 치료된 물과 연결된 재생 시스템에 대해서는 다루지 않음을 명시하고 있습니다. 이는 사용자가 명확하게 농축액을 취급할 때 혼란을 줄이고, 필요한 정보를 효과적으로 전달할 수 있도록 합니다. 결론적으로, EN 13867:2002 표준은 혈액투석 및 관련 치료를 위한 농축액의 질적 기준과 안전관리를 보장하는 데 필수적이며, 관련 분야 전문가 및 사용자에게 매우 중요하고 유용한 지침서 역할을 합니다.
La norme EN 13867:2002, qui concerne les concentrés pour hémodialyse et thérapies connexes, est un document fondamental qui établit des critères rigoureux pour la qualité et la sécurité des concentrés. Son champ d'application se concentre sur les concentrés secs et liquides destinés à être dilués pour être utilisés comme fluides de dialyse. Un des points forts de cette norme est son attention portée à la qualité chimique et microbiologique, garantissant ainsi que les concentrés répondent à des standards élevés de pureté. Cela est essentiel pour assurer la sécurité des patients lors des traitements d'hémodialyse. De plus, la norme traite des exigences concernant le stockage, la manipulation et l'étiquetage des concentrés, ce qui renforce l'intégrité des produits tout au long de leur cycle de vie. La norme EN 13867:2002 comprend également des critères spécifiés pour les contenants et les tests nécessaires afin de surveiller le contenu chimique et microbiologique des concentrés. Ces exigences garantissent que les produits ne présentent aucun risque potentiel avant leur utilisation. Il est à noter que la norme ne couvre pas le mélange final et l'utilisation de ces concentrés, ni les systèmes de régénération des fluides de dialyse, ce qui la rend particulièrement ciblée et pertinente pour les fabricants et les distributeurs de concentrés. Cette spécialisation permet de concentrer les efforts sur les aspects critiques de la qualité des concentrés, sans mélanger les domaines d'application. En résumé, la norme EN 13867:2002 représente un cadre essentiel pour l'industrie des concentrés pour hémodialyse. Sa pertinence réside dans son approche exhaustive de la qualité et de la sécurité, aidant ainsi à protéger les patients et à garantir des traitements efficaces en hémodialyse.
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