EN 1639:1996
(Main)Dentistry - Medical devices for dentistry - Instruments
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 à la conception, aux composants, à la stérilisation, à l'emballage, au marquage, à l'étiquetage ainsi qu'aux informations fournies par le fabricant.
Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Instrumenti
General Information
- Status
- Withdrawn
- Publication Date
- 20-Aug-1996
- Withdrawal Date
- 01-Jun-2004
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55/WG 7 - Steering Committee
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 02-Jun-2004
- Completion Date
- 02-Jun-2004
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 1639:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Medical devices for dentistry - Instruments". This standard covers: 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.
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.
EN 1639:1996 is classified under the following ICS (International Classification for Standards) categories: 11.060.25 - Dental instruments. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1639:1996 has the following relationships with other standards: It is inter standard links to EN 1639:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1639:1996 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1639:1996 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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