EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 7: Alternative Verfahren für Medizinprodukte und Kombinationsprodukte (ISO 13408-7:2012)

Dieser Teil von ISO 13408 legt Anforderungen an alternative Ansätze zur Verfahrenssimulation für die Qualifizierung der aseptischer Herstellung von Medizinprodukten und Kombinationsprodukten fest, die nicht in der Endverpackung sterilisiert werden können und bei denen der Ansatz für die Verfahrenssimulation nach ISO 13408-1 nicht angewendet werden kann, und stellt einen Leitfaden dafür zur Verfügung.
Dieser Teil von ISO 13408 beschreibt, wie die Risikobeurteilung während der Entwicklung eines aseptischen Verfahrens verwendet werden kann, um eine Studie zur Verfahrenssimulation für Medizinprodukte und Kombinationsprodukte in den Fällen zu planen, in denen ein direkten Ersatz des Produktes durch Medien während der aseptischen Herstellung praktisch nicht möglich ist oder nicht das tatsächliche aseptische Verfahren simulieren würde.

Traitement aseptique des produits de santé - Partie 7: Procédés alternatifs pour les dispositifs médicaux et les produits de combinaison (ISO 13408-7:2012)

L'ISO 13408-7:2012 indique les exigences et recommandations concernant les approches alternatives des simulations de procédé pour la qualification du traitement aseptique des dispositifs médicaux et produits combinés qui ne peuvent subir une stérilisation finale et lorsque l'approche de l'ISO 13408-1 ne peut être appliquée.
L'ISO 13408-7:2012 décrit de quelle manière l'évaluation des risques peut servir lors de l'élaboration d'un procédé aseptique afin de concevoir une étude de simulation de procédé pour dispositifs médicaux et produits combinés dans les cas où une simple substitution du produit par un milieu de culture lors du traitement aseptique n'est pas possible ou ne simulerait pas le véritable procédé aseptique.

Aseptična proizvodnja izdelkov za zdravstveno nego - 7. del: Alternativni procesi za medicinske pripomočke in kombinirane izdelke (ISO 13408-7:2012)

Ta del standarda ISO 13408 določa zahteve in podaja smernice za alternativne pristope k simulacijam postopkov za kvalifikacijo aseptične proizvodnje medicinskih pripomočkov in kombiniranih izdelkov, ki jih ni mogoče končno sterilizirati in pri katerih ni mogoče uporabiti pristopa simulacije postopka v skladu z ISO 13408-1. Ta del standarda ISO 13408 opisuje, kako je mogoče uporabiti oceno tveganja med razvojem aseptične proizvodnje za načrtovanje študije simulacije postopka za medicinske pripomočke in kombinirane izdelke, kadar neposredna zamenjava medija za izdelek med aseptično proizvodnjo ni mogoča ali ne bi simulirala dejanske aseptične proizvodnje.

General Information

• Status: Published
• Publication Date: 04-Aug-2015
• Withdrawal Date: 28-Feb-2016
• 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: 05-Aug-2015
• Due Date: 24-Sep-2015
• Completion Date: 05-Aug-2015
• 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN ISO 13408-7:2015 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-7:2015
01-oktober-2015
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO$OWHUQDWLYQLSURFHVL
]DPHGLFLQVNHSULSRPRþNHLQNRPELQLUDQHL]GHONH,62
Aseptic processing of health care products - Part 7: Alternative processes for medical
devices and combination products (ISO 13408-7:2012)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 7: Alternative
Verfahren für Medizinprodukte und Kombinationsprodukte (ISO 13408-7:2012)
Traitement aseptique des produits de santé - Partie 7: Procédés alternatifs pour les
dispositifs médicaux et les produits de combinaison (ISO 13408-7:2012)
Ta slovenski standard je istoveten z: EN ISO 13408-7:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-7:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13408-7:2015

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SIST EN ISO 13408-7:2015

EUROPEAN STANDARD
EN ISO 13408-7

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2015
ICS 11.080.01
English Version
Aseptic processing of health care products - Part 7: Alternative
processes for medical devices and combination products (ISO
13408-7:2012)
Traitement aseptique des produits de santé - Partie 7: Aseptische Herstellung von Produkten für die
Procédés alternatifs pour les dispositifs médicaux et les Gesundheitsfürsorge - Teil 7: Alternative Verfahren für
produits de combinaison (ISO 13408-7:2012) Medizinprodukte und Kombinationsprodukte (ISO 13408-
7:2012)
This European Standard was approved by CEN on 30 July 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-7:2015 E
worldwide for CEN national Members.

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SIST EN ISO 13408-7:2015
EN ISO 13408-7:2015 (E)
Contents
Page
European 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 13408-7:2015
EN ISO 13408-7:2015 (E)
European foreword
The text of ISO 13408-7:2012 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 13408-7:2015 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
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
...