设计确认应当在规定的条件下(初始产品单元、批次或其等价物)进行。

Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.

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该方法依据工程知识表达划分产品单元，同时定义单元约束关系并划分层级。

This method classified different units of products based on engineering knowledge. Different levels of constrains also had been judged.

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有些人说，使用个老方法将使得欧洲重返舞台，这就是“迷你-晶圆厂”—制造小的、灵活的、轻巧的产品单元。

Europe could stage a comeback, some say, should an old idea finally take off: "mini-fabs" -small, flexible and agile production units.

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