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:
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 1642:2004 specifies general requirements for dental implants. 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.
