EN ISO 13408-6:2011

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

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.
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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

Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC Clauses of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 7 This relevant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. SIST EN ISO 13408-6:2011

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 8.3 This relevant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10 8.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. SIST EN ISO 13408-6:2011

Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 98/79/EC on in vitro diagnostic medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC Clauses of this EN Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/Notes 4,5,6,7,8,9,10 B.2.3 This relevant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10 B.2.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard.
Reference numberISO 13408-6:2005(E)© ISO 2005
INTERNATIONAL STANDARD ISO13408-6First edition2005-06-15Aseptic processing of health care products — Part 6: Isolator systems Traitement aseptique des produits de santé — Partie 6: Systèmes isolateurs
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ISO 13408-6:2005(E) © ISO 2005 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Quality system elements.3 4.1 General.3 4.2 Management responsibility.3 4.3 Design control.3 4.4 Measuring instruments and measuring systems.3 5 Design of isolator systems.4 5.1 General.4 5.2 Types of isolators.4 5.3 Materials of construction.4 5.4 Air-handling system.4 5.5 Operator interface.5 5.6 Ancillary equipment.6 6 Facility requirements.6 6.1 Surrounding room classification.6 6.2 Process utilities.7 7 User requirements.7 7.1 Product/process application.7 7.2 Ergonomics.7 7.3 Cleaning.7 7.4 Bio-decontamination.
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