口腔頜面外科用組織再生引導(dǎo)膜材料檢測(cè)

口腔頜面外科用組織再生引導(dǎo)膜材料檢測(cè)項(xiàng)目報(bào)價(jià)？??解決方案？??檢測(cè)周期？??樣品要求？

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YY/T 0526-2009牙科學(xué) 口腔頜面外科用組織再生引導(dǎo)膜材料 技術(shù)文件內(nèi)容

本標(biāo)準(zhǔn)給出了評(píng)價(jià)可吸收、部分吸收或不可吸收的膜材料的化學(xué)、物理、機(jī)械、生物和臨床性能與表現(xiàn)的技術(shù)文件的要求。膜材料可用于：口腔頜面外科引導(dǎo)組織再生以矯正形態(tài)缺陷或異常；與牙齒和（或）牙科種植體接觸；阻止牙周手術(shù)造成的上皮遷移；用于牙科種植體植入前的增骨術(shù)；和（或）用于穩(wěn)定牙科修復(fù)體的增骨術(shù)。本標(biāo)準(zhǔn)不包括主要用于藥物釋放、自體移植物和異體移植物，或者通過藥理、免疫或代謝方式而起作用的材料。

DIN EN ISO 22803-2006牙科學(xué).口腔及頜面外科中受控制的組織再生用薄膜材料.技術(shù)文檔的內(nèi)容

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, whetherresorbable, 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.