ISO 22803:2004

Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file ISO 22803:2004

Publication date:   Sep 3, 2004

General information

90.93 Standard confirmed   Dec 4, 2019

ISO

ISO/TC 106/SC 8 Dental implants

International Standard

11.060.15   Dental implants

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Scope

ISO 22803:2004 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
a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,
b) in contact with teeth and/or dental implants,
c) for prevention of epithelial migration in periodontal surgery,
d) for the augmentation of bone prior to the planned insertion of dental implants,
e) 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 medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.

Life cycle

NOW

PUBLISHED
ISO 22803:2004
90.93 Standard confirmed
Dec 4, 2019