BS EN 1642:2011 - Dentistry. Medical devices for dentistry. Dental implants

BS EN 1642:2011

Dentistry. Medical devices for dentistry. Dental implants

Status : Current, Project Underway   Published : October 2011
Conformity to regulation : Designated



This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

Standard NumberBS EN 1642:2011
TitleDentistry. Medical devices for dentistry. Dental implants
StatusCurrent, Project Underway
Publication Date31 October 2011
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)EN ISO 10993-1, ISO 14971:2007, EN 556-1, EN ISO 1942-5:1994, ISO 11137-1:2006, ISO 8601, EN 21942-2:1992, EN ISO 10451, EN 1041, ISO 1942-1:1989, ISO 1942-5:1989, ISO 1942-2:1989, EN ISO 14971, EN ISO 7405, ISO 22794:2007, EN ISO 14155-1, EN ISO 11607-1, EN ISO 11137-1, EN 21942-1:1991, ISO 22803:2004, EN ISO 22794, ISO 11135-1:2007, EN ISO 14155-2, EN ISO 22803, ISO 14801:2007, ISO 14155-2:2003, ISO 14155-1:2003, ISO 11607-1:2006, EN ISO 11135-1, EN ISO 11607-2, ISO 10451:2002, ISO 10993-1:2003, ISO 11607-2:2006, ISO 7405:2008, EN ISO 14801, EN 980
Informative References(Provided for Information)93/42/EEC, EN ISO 3950, ISO 22442-1:2007, EN ISO 22442-1, EN 1641, CEN/TR 12401
ReplacesBS EN 1642:2009
International RelationshipsEN 1642:2011
DescriptorsDental materials, Packaging, Design, Performance, Sterilization (hygiene), Marking, Instructions for use, Sterile equipment, Dentistry, Labelling (process), Dental prosthesis, Contamination, Implants (surgical)
Title in FrenchMédicine bucco-dentaire. Dispositifs médicaux pour la médicine bucco-dentaire. Implants dentaires
Title in GermanZahnheilkunde. Medizinprodukte für die Zahnheilkunde. Dentalimplantate
ISBN978 0 580 76107 2
File Size880 KB

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