DANSK DS/EN ISO 13504 PDF

This Standard specifies general requirements for instruments and related accessories to be used specifically in dental implantology in the craniofacial area. These requirements apply to instruments when they are manufactured. This includes instruments for single-use and reusable instruments. This International Standard applies to instruments used on the patient which are manually driven instruments and to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer..