如果初期产品符合器械主记录和其他GMP的要求，并且通过设计验证，那么试生产的产品可以进入流通。
Pilot devices may be distributed after design validation of initial units is completed if they meet all of the device master record and other GMP requirements.
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。
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.
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