这些实验室可以向许多客户提供服务，他们中的很多并非医疗器械制造商。
These laboratories may provide services to a number of customers, many of which are not medical device manufacturers.
根据制造商的具体要求进行设计或检测部件或成品器械的合同实验室，被当作该制造商质量体系的延伸部分。
Contract laboratories that designs or test components or finished devices for a manufacturer are considered an extension of the manufacturer's quality system.
参与过程的三方：提供产品的生产商、实施辐照的辐照机构及提供辐照参数的实验室都对医疗器械的无菌质量有贡献。
The three parters which take part in irradiation sterilization: Manufacturer, irradiation organ and Lab offered radiation parameters, all of them contribute to quality of radiation sterilization.
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