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Norm
ÖNORM EN 1641
Issue date: 2010 03 15
Dentistry - Medical devices for dentistry - Materials
Diese Europäische Norm legt allgemeine Anforderungen an die Werkstoffe fest, die in der Zahn-, Mund- und
Kieferheilkunde für die Wiederherstellung der Form und Funktion ...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
Diese Europäische Norm legt allgemeine Anforderungen an die Werkstoffe fest, die in der Zahn-, Mund- und
Kieferheilkunde für die Wiederherstellung der Form und Funktion der Zähne verwendet werden und die Medizinprodukte
sind. Für die Anwendung dieser Norm werden diese Werkstoffe als restaurative Werkstoffe
bezeichnet. Dentalimplantate sind ausdrücklich ausgeschlossen und werden in EN 1642 beschrieben. Diese
Norm legt Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bestandteile, die
Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung und an die Informationen durch den
Hersteller fest.
Für Prüfungen, die die Konformität mit dieser Norm nachweisen, gelten die entsprechenden Normen der
Ebene 3, falls anwendbar.
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ÖNORM EN ISO 24234
Issue date :
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ÖNORM EN ISO 10139-1
Issue date :
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Issue date :
2005 11 01
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ÖNORM EN ISO 6874
Issue date :
2005 12 01
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ÖNORM EN ISO 22112
Issue date :
2006 05 01
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ÖNORM EN ISO 15841
Issue date :
2007 01 01
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Issue date :
2007 02 01
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2009 12 15
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Issue date :
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Issue date :
2009 02 15
Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2008)
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Issue date :
2010 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)