BS EN 1641:2004 - Dentistry. Medical devices for dentistry. Materials – BSI British Standards

BS EN 1641:2004

Dentistry. Medical devices for dentistry. Materials

Status : Revised, Withdrawn   Published : June 2004 Replaced By : BS EN 1641:2009

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BS EN 1641:2004 specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.




Standard NumberBS EN 1641:2004
TitleDentistry. Medical devices for dentistry. Materials
StatusRevised, Withdrawn
Publication Date14 June 2004
Withdrawn Date30 November 2009
Normative References(Required to achieve compliance to this standard)EN 980, EN 1041, EN 21560, EN 21563, ISO 1563:1990, EN 21942-1, EN 21942-2, ISO 1942-2:1989, EN 23107, ISO 3107:1988, EN 26874, ISO 6874:1988, EN 28601, ISO 8601:1988, ISO 8601:1988/Corrigendum 1:1991, EN 29333, ISO 9333:1990, EN 30139-1, ISO 10139-1:1991, EN ISO 1559, ISO 1559:1995, ISO 1559:1995/Corrigendum 1:1997, EN ISO 1561, ISO 1561:1995, EN ISO 1562, ISO 1562:1993, EN ISO 1564, ISO 1564:1995, EN ISO 1567, ISO 1567:1999, EN ISO 1942-5, ISO 1942-5:1989, EN ISO 3336, ISO 3336:1993, EN ISO 4049, ISO 4049:2000, EN ISO 4823, ISO 4823:2000, EN ISO 4824, ISO 4824:1993, EN ISO 6871-1, ISO 6871-1:1994, EN ISO 6872, ISO 6872:1995, EN ISO 6873, ISO 6873:1998, EN ISO 6876, ISO 6876:2001, EN ISO 6877, ISO 6877:1995, EN ISO 7405, ISO 7405:1997, EN ISO 7491, ISO 7491:2000, EN ISO 7551, ISO 7551:1996, EN ISO 8891, ISO 8891:1998, EN ISO 9693, ISO 9693:1999, EN ISO 9917-2, ISO 9917-2:1998, EN ISO 10139-2, ISO 10139-2:1999, EN ISO 10271, ISO 10271:2001, EN ISO 10477, ISO 10477:1992, EN ISO 10993-1, ISO 10993-1:2003, EN ISO 12163, ISO 12163:1999, EN ISO 13716, ISO 13716:1999, EN ISO 14155-1, ISO
Informative References(Provided for Information)93/42/EEC, 2001/83/EC, 67/548/EEC, 1999/45/EC, CEN/TR 12401:2003, EN ISO 14971, ISO 14971:2000, EN 1642
Replaced ByBS EN 1641:2009
ReplacesBS EN 1641:1997
International RelationshipsEN 1641:2004
DescriptorsDentistry, Dental materials, Dental impression materials, Dental filling materials, Dental cements, Dentures, Performance, Packaging, Marking, Labels, Hygiene, Instructions for use
ICS11.060.10
Title in FrenchArt dentaire. Dispositifs medicaux pour l'art dentaire. Produits
Title in GermanZahnheilkunde. Medizinprodukte fuer die Zahnheilkunde. Werkstoffe
CommitteeCH/106/2
ISBN0 580 43917 8
PublisherBSI
FormatA4
DeliveryNo
Pages14
File Size272.8 KB
Price£110.00


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