美国EP文件验证相关资料合集

  • 美国EP文件验证相关资料合集

    0_XT7600 验证相关EP文件清单SZ.xlsx

    1_EP09A2 Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline Second Edition.pdf

    2_EP05A2 Evaluation of Precision Performance of Quantitive Measurement Methods.pdf

    3_EP06A Evaluation of the Linearity of Quantitative Measurement Procedures:A Statistical Aprroach;Approved Guideline.pdf

    4_EP17A (1) Protocols for Determination of Limits of Detection and Limits of Quantitation;Approved Guideline.pdf

    5_EP25A  Evaluation of Stability of IN Vitro Diagnostic Reagents; Approved Guideline.pdf

    6_EP09A2 使用病人样本进行方法学比较和偏差和估算.doc

    7_EP05A2 定量检测方法的精密度评估.doc

    8_EP06A 定量检测方法的线性评估.doc

    9_EP17A 检出限值和定量限值的确定 (1).pdf

    10_EP25A IVD 试剂稳定性评估.doc

     

  • 6739.45KB
  • 法规标准
  • 2021-07-20
  • 医疗器械