BS EN 1640:2004 - Dentistry. Medical devices for dentistry. Equipment – BSI British Standards

BS EN 1640:2004

Dentistry. Medical devices for dentistry. Equipment

Status : Revised, Withdrawn   Published : June 2004 Replaced By : BS EN 1640:2009

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BS EN 1640:2004 specifies general requirements for items of dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.

This European Standard does not include requirements for dental X-ray equipment.

This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by the level 2 and level 3 standards for dental instruments. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.




Standard NumberBS EN 1640:2004
TitleDentistry. Medical devices for dentistry. Equipment
StatusRevised, Withdrawn
Publication Date11 June 2004
Withdrawn Date30 November 2009
Normative References(Required to achieve compliance to this standard)EN 980, EN 1041, EN 1639, EN 21942-1, EN 21942-4, ISO 1942-4:1989, EN 60601-1, IEC 60601-1:1988, EN 60601-2-22, IEC 60601-2-22:1995, EN 60825-1, IEC 60825-1:1993, EN ISO 6875, ISO 6875:1995, EN ISO 7488, ISO 7488:1991, EN ISO 7494, ISO 7494:1996, EN ISO 7494-2, ISO 7494-2:2003, EN ISO 9680, ISO 9680:1993, ISO 9680:1993/Corrigendum 1:1995, EN ISO 9687, ISO 9687:1993, EN ISO 10637, ISO 10637:1999, EN ISO 11143, ISO 11143:1999, EN ISO 11498, ISO 11498:1997, EN ISO 13294, ISO 13294:1997
Informative References(Provided for Information)93/42/EEC, EN ISO 14971, ISO 14971:2000, CEN/TR 12401:2003
Replaced ByBS EN 1640:2009
ReplacesBS EN 1640:1997
International RelationshipsEN 1640:2004
Draft Superseded By02/563818 DC
DescriptorsDental equipment, Dentistry, Performance, Design, Radiation protection, Electrical medical equipment, Electrical safety, Safety measures, Marking, Labels, Instructions for use, Contaminants, Hazards
ICS11.060.20
Title in FrenchArt dentaire. Dispositifs medicaux pour l'art dentaire. Materiel
Title in GermanZahnheilkunde. Medizinprodukte fuer die Zahnheilkunde. Ausruestung
CommitteeCH/106/4
ISBN0 580 43916 X
PublisherBSI
FormatA4
DeliveryNo
Pages16
File Size287.4 KB
Price£130.00


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