摘要：每一年有数千件新的医疗器械进入市场．他们安全吗？ISO最近了一项新的国际标准-ISO14155：2011《受验者用医疗器件的临床试验-良好临床规范》，将有助于较好地评估医疗器械的安全性和性能，提高医疗器械的质量，
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