标准编号：ISO/TR 37137:2014
中文名称：心血管医疗器械的生物学评价 可吸收植入物指南
英文名称：Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
发布日期：2014-05
标准范围
The 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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