SIST EN 1639:2000

Dentistry - Medical devices for dentistry - Instruments

This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.  This standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by the level 2 and level 3 standards, for dental equipment.  Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Instrumente

Diese Europäische Norm legt allgemeine Anforderungen an Instrumente fest, die in der Zahn-, Mund- und Kieferheilkunde verwendet werden und die Medizinprodukte sind. Sie enthält Anforderungen an die vorgesehene Leistung, die Konstruktionsmerkmale, die Bauteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung und die Informationen durch den Hersteller.

Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments

La présente norme européenne établit les exigences relatives aux instruments utilisés dans le cadre de la pratique de l'art dentaire, et qui sont des dispositifs médicaux. Elle établit également les exigences relatives aux performances attendues, aux caractéristiques relatives a la conception, aux composants, a la stérilisation, a l'emballage, au marquage, a l'étiquetage ainsi qu'aux informations fournies par le fabricant.

Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Instrumenti

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 31-Dec-2004
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Jan-2005
• Due Date: 01-Jan-2005
• Completion Date: 01-Jan-2005
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 1639:1996 - Dentistry - Medical devices for dentistry - Instruments

Relations

• Replaced By: SIST EN 1639:2005 - Dentistry - Medical devices for dentistry - Instruments
• Effective Date: 01-Jan-2005

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.QWLZahnheilkunde - Medizinprodukte für die Zahnheilkunde - InstrumenteArt dentaire - Dispositifs médicaux pour l'art dentaire - InstrumentsDentistry - Medical devices for dentistry - Instruments11.060.25Dental instrumentsICS:Ta slovenski standard je istoveten z:EN 1639:1996SIST EN 163
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