FDA-21-CFR-QSR820-中英文对照版本

二手制造商是指加工、改造、翻修、再次包装、修复或对最终器械采取其他措施来对器械的性能或安全规范或预期用途做重要更改的人。(x) Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. 返工是指对不合格产品采取的措施以便使其在放行和销售前满足规定的器械主记录的要求。(y) Specification means any requirement with which a product, process, service, or other activity must conform. 规范是指产品、过程、服务或其他活动必须满足的任何要求。(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. 确认是指通过检查和提供客观证据确认能够持续的满足指定用途的特殊要求。(1) Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. 过程确认是指通过客观证据确定过程能持续生产出满足其预先确定的规范要求。