DIN EN ISO 22794:2009-11

This standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater 90 percent) hydroxyapatite are excluded from this standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials. Materials such as autografts, allografts and membranes, and products for which the primary intended use is to deliver a medicinal product, are not covered by this standard.