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Norm
ÖNORM EN 1640
Issue date: 2010 03 15
Dentistry - Medical devices for dentistry - Equipment
Diese Europäische Norm legt allgemeine Anforderungen an Ausrüstungsgegenstände fest, die in der Zahn-,
Mund- und Kieferheilkunde verwendet werden und die Medizinprodukte...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 15 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
Diese Europäische Norm legt allgemeine Anforderungen an Ausrüstungsgegenstände fest, die in der Zahn-,
Mund- und Kieferheilkunde verwendet werden und die Medizinprodukte sind. Sie enthält Anforderungen an
die geplante Leistung, die Konstruktionsmerkmale, die Bauteile, die Verpackung, die Kennzeichnung, die
Etikettierung und die Informationen durch den Hersteller. Für Prüfungen, die die Konformität mit dieser Norm nachweisen, gelten die entsprechenden Normen der
Ebene 3, falls anwendbar.
Norm
ÖNORM EN 21942-4
Issue date :
1994 05 01
Dental vocabulary - Part 4: Dental equipment (ISO 1942-4:1989)
Norm
ÖNORM EN ISO 6875
Issue date :
1997 04 01
Dental equipment - Dental patient chair (ISO 6875:1995)
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ÖNORM EN ISO 13294
Issue date :
1998 01 01
Dental handpieces - Dental air-motors (ISO 13294:1997)
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ÖNORM EN 1041
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2008 11 01
Information supplied by the manufacturer with medical devices
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ÖNORM EN ISO 11498
Issue date :
1999 09 01
Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
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ÖNORM EN ISO 10637
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2001 02 01
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ÖNORM EN ISO 14155-1
Issue date :
2009 12 01
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
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ÖNORM EN ISO 7494-2
Issue date :
2003 09 01
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ÖNORM EN ISO 14155-2
Issue date :
2009 12 01
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
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ÖNORM EN ISO 17664
Issue date :
2004 06 01
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
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ÖNORM EN ISO 21530
Issue date :
2004 08 01
Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (ISO 21530:2004)
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ÖNORM EN ISO 7494-1
Issue date :
2005 10 01
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2004)
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ÖNORM EN ISO 10650-1
Issue date :
2005 12 01
Dentistry - Powered polymerization activators - Part 1: Quartz tungsten halogen lamps (ISO 10650-1:2004)
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ÖNORM EN ISO 14971
Issue date :
2009 12 15
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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ÖNORM EN ISO 10650-2
Issue date :
2007 12 01
Dentistry - Powered polymerization activators - Part 2: Light-emitting diode (LED) lamps (ISO 10650-2:2007)