EN 13824:2004

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

• Status: Withdrawn
• Publication Date: 23-Nov-2004
• Withdrawal Date: 28-Jun-2011
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 8 - Aseptic processing of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 29-Jun-2011
• Completion Date: 29-Jun-2011
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• 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 13824:2005 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Relations

• Replaced By: EN ISO 13408-3:2011 - Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 13408-2:2011 - Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 13408-1:2011 - Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 13408-6:2011 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 13408-5:2011 - Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 13408-4:2011 - Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
• Effective Date: 08-Jun-2022

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



EN 13824:2004 (E) 2 Contents page Foreword.5 Introduction.6 1 Scope.7 2 Normative references.7 3 Terms and definitions.8 4 Quality management systems.11 5 Personnel.12 5.1 Personnel management.12 5.2 Training for APA qualification.12 5.3 General employee health.13 5.4 Monitoring of personnel.13 5.5 Gowning.14 5.5.1 Gowning training.14 5.5.2 Gowning requirements.14 5.5.3 Control of gowned personnel.14 6 Premises.14 7 Process-related media.15 7.1 Water.
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