按GB/T 3359用随机样本检验数据判定医疗器械总体质量水平

Using Inspection Data of Random Samples to Determine the Population Quality Level of Medical Devices According to GB/T 3359

计量抽样检验目前在中国医疗器械行业应用较少。本文结合两个国外医疗器械标准的实例对GB/T 3359在医疗器械标准中的应用进行了解读,并通过与传统的计数抽样检验进行比较,得出医疗器械检验中采用GB/T 3359进行计量抽样的优势所在。

Sampling inspection by variables is seldom used in medical devices in China presently. This paper unscrambled the application of GB/T 3359 in medical device standards using two examples of foreign medical device standards. By comparing with the traditional sampling inspection by numbers, it concluded the advantages of using GB/T 3359 in medical device inspections.