EN 13824:2004
(Main)Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable.
NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.
Sterilisation von Medizinprodukten - Aseptische Herstellung flüssiger Medizinprodukte - Anforderungen
Dieses Dokument legt Anforderungen an die Gestaltung und den Betrieb aseptischer Verarbeitungs-
einrichtungen und an die Validierung und Routinekontrolle der aseptischen Herstellungsverfahren für sterile
flüssige Medizinprodukte fest. Es gilt nicht für pharmazeutische Produkte, für die Anforderungen an die
einschlägige Gute Herstellungspraxis anzuwenden sind.
ANMERKUNG Viele der in diesem Dokument enthaltenen Prinzipien können auf bestimmte unter aseptischen
Bedingungen hergestellte Medizinprodukte im festen Zustand angewendet werden.
Stérilisation des dispositifs médicaux - Traitement aseptique des dispositifs médicaux liquides - Exigences
Le présent document spécifie les exigences relatives à la conception et au fonctionnement des installations de traitement aseptique et à la validation et au contrôle de routine des procédés aseptiques en vue de la préparation de dispositifs médicaux liquides stériles. Elle ne s'applique pas aux produits pharmaceutiques pour lesquels les exigences relatives aux bonnes pratiques de fabrication appropriées s'appliquent.
NOTE De nombreux principes spécifiés dans cette Norme peuvent être appliqués à certains dispositifs médicaux solides traités dans des conditions d'asepsie.
Sterilizacija medicinskih pripomočkov – Aseptična proizvodnja tekočih medicinskih pripomočkov - Zahteve
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilization of medical devices - Aseptic processing of liquid medical devices - RequirementsRþLKStérilisation des dispositifs médicaux - Traitement aseptique des dispositifs médicaux liquides - ExigencesSterilisation von Medizinprodukten - Aseptische Herstellung flüssiger Medizinprodukte - AnforderungenTa slovenski standard je istoveten z:EN 13824:2004SIST EN 13824:2005en11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:SLOVENSKI
STANDARDSIST EN 13824:200501-marec-2005
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13824November 2004ICS 11.080.01English versionSterilization of medical devices - Aseptic processing of liquidmedical devices - RequirementsStérilisation des dispositifs médicaux - Traitementaseptique des dispositifs médicaux liquides - ExigencesSterilisation von Medizinprodukten - Aseptische Herstellungflüssiger Medizinprodukte - AnforderungenThis European Standard was approved by CEN on 14 October 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13824:2004: E
Conventional cleanrooms.28 A.1 Facility design features.28 A.2 Facility design review.29 A.3 Material flow.29 A.4 Aseptic processing area (APA).29 A.5 Critical processing zones.29 A.6 Other processing zones within the APA.30 A.7 Support areas outside the APA.30 A.8 Environmental air systems and controls.30 A.8.1 Temperature and humidity.31 A.8.2 Air.31 A.8.3 HEPA filter integrity.31 A.8.4 Air handling.32 A.9 Facility design.32 A.10 Preparation areas.32 Annex B (normative)
Isolator technology.33 B.1 Types of isolator.33 B.1.1 General.33 B.1.2 Transfer devices used with isolators.33 B.2 Transfer devices.
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