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Updated: Jul 27, 2025

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[关于体外诊断试剂检查实践的简短讨论

Ting He1, Shuang Chu1, Jing Xie1

  • 1Shanghai Center for Medical Device and Cosmetics Evaluation and Verification, Shanghai, 200020.

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
|June 8, 2023
PubMed
概括

医疗器械注册自我检查的新规定于2021年发布. 本研究讨论了他们对体外诊断试剂的要求,以帮助行业遵守规定.

关键词:
在体外诊断试剂试剂医疗器械注册医疗器械的注册情况自己检查的自我检查.

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相关概念视频

Data Validation01:15

Data Validation

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
193