Dentistry

If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:

• Active Implantable Medical Devices (AIMDD) Council Directive 90/385/EEC (1990)
• Medical Devices Directive (MDD) Council Directive 93/42/EEC (1992)
• In Vitro Diagnostic Directive (IVDD) Council Directive 98/79/EC (1998).

BSI’s European and International standards provide essential reference on medical devices for dentistry. Also, standards in this area specify requirements and test methods dental cartridge syringes and for the materials, design and construction of the water and air supply within dental units.

BS EN 1641:2004
Dentistry. Medical devices for dentistry. Materials

BS EN 1642:2004
Dentistry. Medical devices for dentistry. Dental implants

BS EN ISO 15912:2006
Dentistry. Casting investments and refractory die materials

BS EN ISO 15841:2006
Dentistry. Wires for use in orthodontics

BS EN ISO 21671:2006
Dentistry. Rotary polishers

BS EN ISO 4073:2009
Dentistry. Information system on the location of dental equipment in the working area of the oral health care provider

BS EN ISO 10139-2:2009
Dentistry. Soft lining materials for removable dentures. Materials for long-term

PD CEN/TR 12401:2009
Dentistry. Guidance on the classification of dental devices and accessories

BS EN ISO 7405:2008
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

BS EN ISO 21531:2009
Dentistry. Graphical symbols for dental instruments

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