BS EN ISO 22803:2005 2006
$102.76
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
| Published By | Publication Date | Number of Pages |
| BSI | 2006 | 16 |
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
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for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,
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in contact with teeth and/or dental implants,
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for prevention of epithelial migration in periodontal surgery,
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for the augmentation of bone prior to the planned insertion of dental implants,
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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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | TitlePage – Dentistry�— Membrane materials for guided tissue regeneration in oral and maxillofaci… |
| 7 | Foreword – Foreword |
| 8 | Introduction – Introduction |
| 9 | Scope – 1��� Scope NormativeReference – 2��� Normative references |
| 11 | Clause1 – 4��� General description |
| 12 | Clause1 – 5��� Contents of a technical file Subclause2 – 5.1��� General Subclause2 – 5.2��� Chemical composition Subclause2 – 5.3��� Intended performance Subclause2 – 5.4��� Preclinical and clinical evaluation Subclause3 – 5.4.1��� General |
| 13 | Subclause3 – 5.4.2��� Preclinical evaluation Subclause3 – 5.4.3��� Clinical evaluation Subclause2 – 5.5��� Manufacture Subclause2 – 5.6��� Sterilization Subclause3 – 5.6.1��� Products supplied sterile |
| 14 | Subclause3 – 5.6.2��� Sterilization residuals Subclause2 – 5.7��� Packaging Subclause3 – 5.7.1��� Protection from damage in storage and transport Subclause3 – 5.7.2��� Maintenance of sterility in transit Subclause2 – 5.8��� Additional information supplied by the manufacturer Subclause3 – 5.8.1��� General Subclause3 – 5.8.2��� Restrictions on combinations Subclause3 – 5.8.3��� Identification of membrane materials |
| 15 | Bibliography – Bibliography |
