EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product.
ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer.
ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 4: Reinigung vor Ort (ISO 13408-4:2005)

Der vorliegende Teil von ISO 13408 legt die allgemeinen Anforderungen an die Verfahren zur Reinigung vor
Ort (CIP-Verfahren) fest, die auf die Produktkontaktflächen der Ausrüstung angewendet werden, welche 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.
Der vorliegende Teil von ISO 13408 ist anwendbar auf Verfahren, bei denen Reinigungsmittel auf die
innenliegenden Oberflächen der für das CIP-Verfahren ausgelegten Ausrüstung, die in Kontakt mit dem
Produkt kommen können, aufgebracht werden.
Der vorliegende Teil von ISO 13408 ist nicht anwendbar auf Verfahren, bei denen die Ausrüstung demontiert
und in einer Waschanlage gereinigt wird.
Der vorliegende Teil von ISO 13408 ersetzt keine behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken
(GMP) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale
Zuständigkeiten betreffen.

Traitement aseptique des produits de santé - Partie 4: Technologies de nettoyage sur place (ISO 13408-4:2005)

L'ISO 13408-4:2005 spécifie les exigences générales relatives au nettoyage sur place (NSP) appliqué aux surfaces de l'équipement utilisé pour la fabrication de produits de santé stériles et se trouvant en contact avec le produit 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 13408-4:2005 s'applique aux processus dans lesquels des agents nettoyants sont appliqués sur les surfaces internes de l'équipement qui peuvent être nettoyées sur place, et qui peuvent entrer en contact avec le produit.
L'ISO 13408-4:2005 ne s'applique pas aux processus dans lesquels l'équipement est démonté et nettoyé dans une laveuse.
L'ISO 13408-4:2005 ne emplace pas ni n'annule 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 - 4. del: Tehnologija čiščenja na mestu proizvodnje (ISO 13408-4:2005)

Ta del ISO 13408 določa splošne zahteve za procese čiščenja 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. Ta del ISO 13408 velja za procese, kjer se čistilna sredstva nanašajo na notranje površine opreme, skladne s CIP, ki lahko pride v stik s proizvodom. Ta del ISO 13408 ne velja za procese, kjer se oprema razstavi in opere v pralnem stroju. 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: 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 13408-4:2011 - Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

Relations

• Replaces: EN 13824:2004 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-4:2011
01-oktober-2011
1DGRPHãþD
SIST EN 13824:2005
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO7HKQRORJLMDþLãþHQMD
QDPHVWXSURL]YRGQMH,62
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO
13408-4:2005)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 4: Reinigung
vor Ort (ISO 13408-4:2005)
Traitement aseptique des produits de santé - Partie 4: Technologies de nettoyage sur
place (ISO 13408-4:2005)
Ta slovenski standard je istoveten z: EN ISO 13408-4:2011
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-4:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13408-4:2011

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SIST EN ISO 13408-4:2011


EUROPEAN STANDARD
EN ISO 13408-4

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2011
ICS 11.080.01 Supersedes EN 13824:2004
English Version
Aseptic processing of health care products - Part 4: Clean-in-
place technologies (ISO 13408-4:2005)
Traitement aseptique des produits de santé - Partie 4: Aseptische Herstellung von Produkten für die
Technologies de nettoyage sur place (ISO 13408-4:2005) Gesundheitsfürsorge - Teil 4: Reinigung vor Ort (ISO
13408-4:2005)
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 Ref. No. EN ISO 13408-4:2011: E
worldwide for CEN national Members.

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

2

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SIST EN ISO 13408-4:2011
EN ISO 13408-4:2011 (E)
Foreword
The text of ISO 13408-4:2005 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 13408-4:2011 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 A
...