BS EN ISO 22794:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Implantable materials
5 Technical file
  5.1 Contents
  5.2 Chemical composition
  5.3 Physical properties
  5.4 Intended applications, precautions, warnings and
       instructions
  5.5 Preclinical and clinical evaluation
  5.6 Manufacture
  5.7 Materials of animal origin
  5.8 Sterilization
  5.9 Packaging
  5.10 Additional information supplied by the manufacturer
Bibliography

Pertains to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery.

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.