EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005)

Der vorliegende Teil von ISO 13408 legt die Anforderungen an Isolatorensysteme fest, die bei der
aseptischen Herstellung eingesetzt werden, und stellt einen Leitfaden zur Qualifizierung, Biodekontamination,
Validierung, zum Betrieb und zur Kontrolle von Isolatorensystemen, die bei der aseptischen Herstellung von
Produkten für die Gesundheitsfürsorge eingesetzt werden, zur Verfügung.
Der vorliegende Teil von ISO 13408 ist auf die Anwendung von Isolatorensystemen zur Aufrechterhaltung
aseptischer Bedingungen ausgerichtet; das kann die Anwendung gefährlicher Stoffe einschließen.
Der vorliegende Teil von ISO 13408 ersetzt keine nationalen behördlichen Anforderungen, wie z. B. Gute
Herstellungspraktiken (en: Good Manufacturing Practices, GMP) und/oder Anforderungen von Arzneibüchern,
die insbesondere nationale oder regionale Zuständigkeiten betreffen.

Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-6:2005)

L'ISO 13408-6:2005 spécifie les exigences en matière de systèmes isolateurs utilisés pour le traitement aseptique et indique les lignes directrices relatives à la qualification, la biodécontamination, la validation, le fonctionnement et le contrôle des systèmes isolateurs utilisés pour le traitement aseptique des produits de santé.
L'ISO 13408-6:2005 se concentre sur l'utilisation des systèmes isolateurs afin de maintenir les conditions aseptiques. Cela peut inclure les applications pour les matières dangereuses.
L'ISO 13408-6:2005 n'a pas pour vocation de remplacer ou d'annuler des exigences réglementaires nationales, telles que les bonnes pratiques de fabrication (BPF) et/ou les exigences officielles, qui relèvent des juridictions nationales ou régionales particulières.

Aseptična proizvodnja izdelkov za zdravstveno nego - 6. del: Sistemi izolatorjev (ISO 13408-6:2005)

Ta del ISO 13408 določa zahteve za sisteme izolatorjev, uporabljene za aseptično proizvodnjo, in ponuja smernice za kvalifikacijo, biodekontaminacijo, validacijo, delovanje in nadzor sistemov izolatorjev, uporabljenih za aseptično proizvodnjo izdelkov za zdravstveno nego. Ta del ISO 13408 je osredotočen na uporabo sistemov izolatorjev za vzdrževanje aseptičnih pogojev; to lahko vključuje uporabo nevarnih materialov. Ta del ISO 13408 ne nadomešča ali zamenjuje nacionalnih regulatornih zahtev, kot so dobre prakse proizvodnje (GMP) in/ali strnjene zahteve, ki se nanašajo na nekatere državne ali regijske pristojnosti.

General Information

• Status: Withdrawn
• Publication Date: 28-Jun-2011
• Withdrawal Date: 18-May-2021
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 19-May-2021
• 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
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 13408-6:2011 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

Relations

• Replaces: EN 13824:2004 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 13408-6:2021 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
• Effective Date: 31-May-2017
• Amended By: EN ISO 13408-6:2011/A1:2013 - Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005/Amd 1:2013)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005)Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-6:2005)Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN ISO 13408-6:2011SIST EN ISO 13408-6:2011en01-oktober-2011SIST EN ISO 13408-6:2011SLOVENSKI
STANDARDSIST EN 13824:20051DGRPHãþD



SIST EN ISO 13408-6:2011



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13408-6
June 2011 ICS 11.080.01 Supersedes EN 13824:2004English Version
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Traitement aseptique des produits de santé - Partie 6: Systèmes isolateurs (ISO 13408-6:2005)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005) This European Standard was approved by CEN on 10 June 2011.
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-CENELEC 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-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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 © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13408-6:2011: ESIST EN ISO 13408-6:2011



EN ISO 13408-6:2011 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .4Annex ZB (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices .5Annex ZC (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6 SIST EN ISO 13408-6:2011



EN ISO 13408-6:2011 (E) 3 Foreword The text of ISO 13408-6:2005 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 13408-6:2011 by Technical Committee CEN/TC 204 “Sterilization of 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 December 2011, and conflicting national standards shall be withdrawn at the latest by December 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13824:2004. 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 Directives. For relationship with EU Directives, see informative Annexes ZA, ZB, or ZC, which are integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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 the United Kingdom. Endorsement not
...