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现行 ISO 22803:2004
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Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file 牙科与医学博士;口腔颌面外科引导组织再生用膜材料——技术文件的内容
发布日期: 2004-09-03
ISO 22803:2004给出了对所使用的膜材料(无论是可吸收、部分可吸收还是不可吸收)的化学、物理、机械、生物和临床方面和性能进行评估的技术文件的要求 a) 用于口腔颌面外科引导组织再生,以纠正形态缺陷或异常, b) 与牙齿和/或牙齿植入物接触, c) 预防牙周手术中的上皮迁移, d) 在计划植入牙科植入物之前进行骨增强, e) 和/或用于增强骨以稳定牙科修复体。 本国际标准不适用于主要预期用途为提供医药产品、自体移植物和同种异体移植物的材料,或通过药理学、免疫学或代谢手段发挥作用的材料。
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.
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归口单位: ISO/TC 106/SC 8
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