Dentistry — Membrane materials for guided tissue

Document Number: NL ISO 22803 : 2019
Sector: Health Care Technology
TC: NL TC 106
ICS: 11.060.15
This International Standard gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used — for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality, — in contact with teeth and/or dental implants, — for prevention of epithelial migration in periodontal surgery, — for the augmentation of bone prior to the planned insertion of dental implants, — and/or for augmentation of bone for stabilization of dental prostheses. This International Standard is not applicable to materials whose primary intended use is to deliver a medicinalproduct, autografts and allografts, or materials intended to act through pharmacological, immunological ormetabolic means.