EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 5: Sterilisation vor Ort (ISO 13408-5:2006)

1.1 Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an die Sterilisation vor Ort
(SIP) fest, die auf die Produktkontaktflächen der Ausrüstung angewendet werden, die bei der Herstellung
steriler Produkte für die Gesundheitsfürsorge durch aseptische Herstellung eingesetzt wird, und stellt einen
Leitfaden zur Qualifizierung, Validierung, zum Arbeitsablauf und zur Kontrolle zur Verfügung.
ANMERKUNG Die SIP kann unter Verwendung von Dampf oder anderen gasförmigen oder flüssigen Sterilisiermitteln
erreicht werden. Ein spezieller Leitfaden für die Dampfsterilisation vor Ort, die das am häufigsten angewendete Verfahren
ist, ist in Anhang A angeführt.
1.2 Der vorliegende Teil von ISO 13408 gilt für Verfahren, bei denen Sterilisiermittel auf die innenliegenden
Oberflächen der Ausrüstung, die in Kontakt mit dem Produkt kommen können, aufgebracht werden.
1.3 Der vorliegende Teil von ISO 13408 gilt nicht für Verfahren, bei denen die Ausrüstung demontiert und in
einen Sterilisator eingebracht wird.
1.4 Der vorliegende Teil von ISO 13408 ersetzt keine behördlichen Anforderungen, wie z. B. Gute
Herstellungspraktiken (en: Good Manufacturing Practices, GMP) und/oder Anforderungen von Arzneibüchern,
die insbesondere nationale oder regionale Zuständigkeiten betreffen.
1.5 Der vorliegende Teil von ISO 13408 legt keine Anforderungen an die Entwicklung, Validierung und
Routinekontrolle eines Verfahrens zur Inaktivierung der Erreger spongiformer Enzephalopathien, wie z. B.
Scarpie, bovine spongiforme Enzephalopathie oder Creutzfeld-Jakob-Krankheit, fest. In einzelnen Ländern
wurden spezielle Empfehlungen für die Verarbeitung von Materialien, die möglicherweise mit diesen Erregern
kontaminiert sind, erarbeitet.
ANMERKUNG Siehe auch ISO 22442-1, ISO 22442-2 und ISO 22442-3.

Traitement aseptique des produits de santé - Partie 5: Stérilisation sur place (ISO 13408-5:2006)

L'ISO 13408-5:2006 spécifie les exigences générales relatives à la stérilisation sur place (SSP) appliquée aux surfaces de l'équipement utilisé pour la fabrication de produits de santé stériles et se trouvant en contact avec le produit, et ce en procédant à un traitement aseptique; elle propose également des directives relatives à la qualification, à la validation, à l'exploitation et au contrôle.
L'ISO 13408-5:2006 s'applique aux procédés au cours desquels des agents stérilisants sont administrés aux surfaces internes de l'équipement qui peuvent être en contact avec le produit.

Aseptična proizvodnja izdelkov za zdravstveno nego - 5. del: Sterilizacija na mestu proizvodnje (ISO 13408-5:2006)

Ta del ISO 13408 določa splošne zahteve za procese sterilizacije na mestu proizvodnje, uporabljene za površine opreme, ki je v stiku s proizvodi, uporabljanimi v proizvodnji sterilnih izdelkov za zdravstveno nego z aseptično proizvodnjo, in ponuja smernice za kvalifikacijo, validacijo, delovanje in nadzor.

General Information

• Status: Published
• Publication Date: 28-Jun-2011
• Withdrawal Date: 30-Dec-2011
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Jun-2011
• Due Date: 16-Apr-2012
• 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
• 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 13408-5:2011 - Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

Relations

• Replaces: EN 13824:2004 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• 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 5: Sterilisation vor Ort (ISO 13408-5:2006)Traitement aseptique des produits de santé - Partie 5: Stérilisation sur place (ISO 13408-5:2006)Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN ISO 13408-5:2011SIST EN ISO 13408-5:2011en01-oktober-2011SIST EN ISO 13408-5:2011SLOVENSKI
STANDARDSIST EN 13824:20051DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13408-5
June 2011 ICS 11.080.01 Supersedes EN 13824:2004English Version
Aseptic processing of health care products -Part 5: Sterilization in place (ISO 13408-5:2006)
Traitement aseptique des produits de santé - Partie 5: Stérilisation sur place (ISO 13408-5:2006)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 5: Sterilisation vor Ort (ISO 13408-5:2006) 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 13408-5:2011: ESIST EN ISO 13408-5:2011

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 13408-5:2011

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 13408-5:2011

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 13408-5:2011

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.
INTERNATIONALSTANDARDISO13408-5First edition2006-11-15Reference numberISO13408-5:2006(E)© ISO2006Aseptic processing of health care products—Part5:Sterilization in placeTraitement aseptique des produits de santé—Partie5: Stérilisation sur place
ISO13408-5:2006(E)ii© ISO2006–All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shallnot be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. Indownloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariataccepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creationparameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In theunlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.©ISO2006All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below orISO's member body in the country of the requester.ISO copyright officeCase postale 56  CH-1211 Geneva 20Tel.+ 41 22 749 01 11Fax+ 41 22 749 09 [e-mail] in SwitzerlandSIST EN ISO 13408-5:2011

ISO13408-5:2006(E)© ISO2006–All rights reservediiiContents Page1Scope . 12Normative references . 13Terms and definitions . 24Quality system elements . 34.1General . 34.2Management responsibility . 34.3Design control . 34.4Measuring instruments and measuring systems . 35Process and equipment characterization . 45.1General concepts . 45.2Effectiveness of sterilization in place (SIP) . 45.3Equipment . 46Sterilizing agent characterization . 66.1Selection of sterilizing agent(s) . 66.2Quality of sterilizing agent(s) . 66.3Safety and the environment . 67SIP process . 67.1Process parameters . 67.2Cycle development . 78Validation . 78.1Validation protocol . 78.2Design qualification . 78.3Installation qualification . 78.4Operational qualification . 88.5Performance qualification . 88.6Review and approval of valida
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