BS EN ISO 22794:2009

This standard BS EN ISO 22794:2009 Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file is classified in these ICS categories:

• 35.080 Software
• 11.060.15 Dental implants

This International 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 (> 90 %) hydroxyapatite are not covered by this International 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 International Standard.