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一、引言ＩＳＯ ＴＣ 194自 1989年成立以来 ,相继制定了ＩＳＯ 10 993《医疗器械生物学评价》系列标准。该体系标准广泛适用于与人体直接或间接接触的医疗器械的生物学评价。ＩＳＯ 10 993 -1《医疗器械生物学评价第 1部分 :评价与试验》是该系列标准中最为重要的纲领性标准。
I. INTRODUCTION Since its establishment in 1989, ISO TC 194 has successively formulated the ISO 10 993 “Biological Evaluation of Medical Devices” series of standards. This system standard is widely applicable to the biological evaluation of medical devices that are in direct or indirect contact with the human body. ISO 10 993-1 “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” is the most important programmatic standard in this series of standards.