BS EN 1639:2004 - Dentistry. Medical devices for dentistry. Instruments – BSI British Standards

BS EN 1639:2004

Dentistry. Medical devices for dentistry. Instruments

Status : Revised, Withdrawn   Published : June 2004 Replaced By : BS EN 1639:2009

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BS EN 1639:2004 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 European 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 European Standard are contained in the level 3 standards, if appropriate.




Standard NumberBS EN 1639:2004
TitleDentistry. Medical devices for dentistry. Instruments
StatusRevised, Withdrawn
Publication Date11 June 2004
Withdrawn Date30 November 2009
Normative References(Required to achieve compliance to this standard)EN 550, EN 552, EN 554, EN 556-1, EN 980, EN 1041, EN 1640, EN 21942-1, EN 21942-3, ISO 1942-3:1989, EN 23964, ISO 3964:1982, EN 26360-2, EN 28325, ISO 8325:1985, EN 28601, ISO 8601:1988, EN 29168, ISO 9168:1991, EN 60601-1, EN ISO 1797-1, ISO 1797-1:1992, EN ISO 1797-2, ISO 1797-2:1992, EN ISO 2157, ISO 2157:1992, EN ISO 3630-1, ISO 3630-1:1992, EN ISO 3630-2, ISO 3630-2:2000, EN ISO 3630-3, ISO 3630-3:1994, EN ISO 3823-1, ISO 3823-1:1997, EN ISO 3823-2, ISO 3823-2:2003, EN ISO 6360-1, ISO 6360-1:2004, EN ISO 7153-1, ISO 7153-1:1991, EN ISO 7492, ISO 7492:1997, EN ISO 7711-1, ISO 7711-1:1997, EN ISO 7711-2, ISO 7711-2:1992, EN ISO 7711-3, ISO 7711-3:1992, EN ISO 7785-1, ISO 7785-1:1997, EN ISO 7785-2, ISO 7785-2:1995, EN ISO 7885, ISO 7885:2000, EN ISO 9173-1, ISO 9173-1:1991, EN ISO 9687, ISO 9687:1993, EN ISO 9873, ISO 9873:1998, EN ISO 9997, ISO 9997:1999, EN ISO 10323, ISO 10323:1991, EN ISO 13295, ISO 13295:1994, EN ISO 13397-1, ISO 13397-1:1995, EN ISO 13397-2, ISO 13397-2:1996, EN ISO 13397-3, ISO 13397-3:1996, EN ISO 13397-4, ISO 13397-4:1997, EN ISO 13402, ISO 13402:1995, E
Informative References(Provided for Information)93/42/EEC, EN ISO 14971, ISO 14971:2000, CEN/TR 12401:2003, EN ISO 11499, ISO 11499:1997
Replaced ByBS EN 1639:2009
ReplacesBS EN 1639:1997
International RelationshipsEN 1639:2004
DescriptorsDental equipment, Dental handpieces, Dental instruments, Dentistry, Medical equipment, Labels, Marking, Instructions for use, Design, Sterilization (hygiene), Contamination, Equipment safety, Performance
ICS11.060.25
Title in FrenchArt dentaire. Dispositifs medicaux pour l'art dentaire. Instruments
Title in GermanZahnheilkunde. Medizinprodukte fuer die Zahnheilkunde. Instrumente
CommitteeCH/106/4
ISBN0 580 43915 1
PublisherBSI
FormatA4
DeliveryNo
Pages18
File Size319.4 KB
Price£130.00


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