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本帖最后由 ICBC 于 2018-4-4 11:09 编辑
灭菌器的鉴定/验证是非常重要的一项工作，正所谓“工欲善其事，必先利其器”。那么，灭菌器的鉴定/验证包括哪些呢？
大致来说也就是4个方面：
①安装鉴定（Installation Qualification,IQ）:证明设备已按照规范要求提供和安装，获得并形成文件化证据的过程。（GB/T 19971-2015）
IQ:process of establishing by objective evidence that all key aspects of the process equipment and ancillary system installation comply with the approved specification.(ISO 11139-2017)
②运行鉴定（Operationalqualification,OQ）：证明已安装的设备按运行程序使用时能在一定限值内运行，获得并形成文件化的过程。（GB/T 19971-2015）
OQ:process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures.(ISO 11139-2017)
③性能鉴定（Performance Qualification, PQ）：证明已按操作程序安装和运行的设备，可持续地按预定规范生产出符合规格的产品，获得并形成文件化证据的过程。（GB/T 19971-2015）
PQ:process of establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.(ISO 11139-2017)
④再鉴定（Re-qualification）：为证实某一规定过程持续合格而重新进行的部分确认活动。（GB/T 19971-2015）
Requalification: repetition of part or all of validation for the purpose of confirming the continued acceptability of a specified process. (ISO 11139-2017)
注：在外文规范中会见到“常规测试(Routine test,RT)和定期测试(Periodic test,PT)”，它们属于再鉴定的范畴。在ISO 11139-2017中给出了RT的定义，而没有给出PT的定义。这两个属于都没有列入GB/T 19971-2015中。
Routine test: technical operation conducted periodically to establish that the operational performance of the equipment or process remains within the limits established during validation.(ISO 11139-2017)
具体的验证，请参看附图。
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发表于 2018-4-4 11:09