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Cardiovascular biological evaluation of medical device - Guidance for absorbable implants 医疗器械的心血管生物学评价.可吸收植入物指南
发布日期: 2014-11-28
本技术报告的目的是就10993系列中各种试验方法的潜在调整提供临时部分指导,以说明可吸收医疗器械中可溶性成分或降解产物的有意释放。内容旨在增加清晰度,并提供潜在可接受的方法,以减少因可吸收材料的性质而产生错误或误导性结果的可能性。所有建议均应视为初步建议,可能会发生变化,最终处置应通过直接修改ISO 10993的相应部分来实施。因此,临时采用任何上述调整都需要附带书面理由。
he objective of this Technical Report is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.
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