Input relating to product requirements shall be determined and records maintained (see4.2.4). These inputs shall include.

与产品要求有关的输入应加以决定与记录(见4.2.4)。这些应包括。

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As for incomplete, vague or contradictory requirements, the team leader should discuss with required responsible departments to solve them, and keep the result in product design input report.

对不完整的、含糊的、或矛盾的要求，应在设计前与要求的责任单位共同协商解决，其结果记录于《设计评审报告》中。

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A set of design input requirements, when converted to engineering terminology, finalized and accepted as part of the device master record is called a device or product specification.

当设计成套的输入的规定被转换成工程术语，并在器械主记录中得到最终确认并成为记录一部分，这些成套规定就被称之为器械或产品规格。

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