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<\/p>\n
for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,<\/p>\n<\/li>\n
in contact with teeth and\/or dental implants,<\/p>\n<\/li>\n
for prevention of epithelial migration in periodontal surgery,<\/p>\n<\/li>\n
for the augmentation of bone prior to the planned insertion of dental implants,<\/p>\n<\/li>\n
and\/or for augmentation of bone for stabilization of dental prostheses.<\/p>\n<\/li>\n<\/ul>\n
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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 5<\/td>\n | TitlePage – Dentistry\ufffd\u2014 Membrane materials for guided tissue regeneration in oral and maxillofaci… <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword – Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction – Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Scope – 1\ufffd\ufffd\ufffd Scope NormativeReference – 2\ufffd\ufffd\ufffd Normative references <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Clause1 – 4\ufffd\ufffd\ufffd General description <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Clause1 – 5\ufffd\ufffd\ufffd Contents of a technical file Subclause2 – 5.1\ufffd\ufffd\ufffd General Subclause2 – 5.2\ufffd\ufffd\ufffd Chemical composition Subclause2 – 5.3\ufffd\ufffd\ufffd Intended performance Subclause2 – 5.4\ufffd\ufffd\ufffd Preclinical and clinical evaluation Subclause3 – 5.4.1\ufffd\ufffd\ufffd General <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Subclause3 – 5.4.2\ufffd\ufffd\ufffd Preclinical evaluation Subclause3 – 5.4.3\ufffd\ufffd\ufffd Clinical evaluation Subclause2 – 5.5\ufffd\ufffd\ufffd Manufacture Subclause2 – 5.6\ufffd\ufffd\ufffd Sterilization Subclause3 – 5.6.1\ufffd\ufffd\ufffd Products supplied sterile <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | Subclause3 – 5.6.2\ufffd\ufffd\ufffd Sterilization residuals Subclause2 – 5.7\ufffd\ufffd\ufffd Packaging Subclause3 – 5.7.1\ufffd\ufffd\ufffd Protection from damage in storage and transport Subclause3 – 5.7.2\ufffd\ufffd\ufffd Maintenance of sterility in transit Subclause2 – 5.8\ufffd\ufffd\ufffd Additional information supplied by the manufacturer Subclause3 – 5.8.1\ufffd\ufffd\ufffd General Subclause3 – 5.8.2\ufffd\ufffd\ufffd Restrictions on combinations Subclause3 – 5.8.3\ufffd\ufffd\ufffd Identification of membrane materials <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | Bibliography – Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file<\/b><\/p>\n |