欧盟医疗器械标准管理体系由指令、协调标准以及符合性评估程序组成。
Medical devices standards system in EU is composed of directive, harmonized standards and conformity assessment procedures.
医疗器械标准信息在产品的研发、生产、质量管理等环节具有很重要的作用。
The information of medical instrument standard plays an important role in the development, manufacturing, quality control and other links of the products.
随后论文第二章是关于医疗器械标准的分类、技术法规、自愿标准、医疗器械国际标准制定组织等标准相关的基础内容。
S. , Europe and China. The second chapter is about the classification of medical device standards, technical regulation, voluntary standards, international standards organization.
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