| 叶青,李海芳,尹薛荣,张军.药品检验机构仪器设备检定校准结果确认方法的探讨[J].中国药事,2022,36(3):287-292 |
| 药品检验机构仪器设备检定校准结果确认方法的探讨 |
| Confirmation of the Results of Metrological Verification and Calibration of Instruments and Equipment in Laboratory |
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| DOI：10.16153/j.1002-7777.2022.03.008 |
| 中文关键词: 检定 校准 结果确认 仪器 |
| 英文关键词: metrological verification calibration confirmation of results instruments |
| 基金项目:新疆维吾尔自治区创新环境(人才、基地)建设专项——科技创新基地建设(资源共享平台建设)(编号 PT2005) |
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| 中文摘要: |
| 目的：规范药品检验机构仪器设备检定校准结果的确认工作，确保仪器设备性能满足使用要求。 方法：按照CNAS-CL01-G002:2021《测量结果的计量溯源性要求》规定，结合药品检测机构仪器设备检定校准结果确认工作中常见的问题，对如何进行检定校准结果的确认进行探讨。结果与讨论：实验室应从检定校准证书的完整性和规范性，溯源结果与预期使用要求的符合性，仪器设备是否需要调整、修正、降级和限制使用范围，检定校准结果是否影响所开展项目的测量不确定度评定4个方面进行计量确认。建议实验室根据检测标准及技术规范制定计量确认操作规程，并对计量确认人员进行充分的培训， 确保计量确认结果有效，检验检测数据准确可靠。 |
| 英文摘要: |
| Objective: To standardize the confirmation of metrological verification and calibration results of instruments and equipment in drug testing institutions to ensure that the performance of them meets the application requirements. Methods: According to the provisions of CNAS-CL01-G002:2021 “Requirements on the Metrological Traceability of Measurement Results” and combined with common problems in metrological verification and calibration of instruments and equipment in drug testing institutions. The ways to conduct confirmation of the metrological verification and calibration results of instruments and equipment were discussed. Results and Conclusion: The laboratory should make metrological confirmation in four aspects, the integrity and standardization of verification and calibration certificates, the conformity of the metrological traceability results with the expected use requirements, whether the instrument and equipment need to be adjusted, revised, degraded, and limited in use, whether the verification and calibration results affect the evaluation of the measurement uncertainty of the project. It is recommended that laboratory should establish metrological confirmation operating procedures according to testing standards and technical specifications, and provide adequate training for confirmation stuff to ensure that the metrological confirmation results are valid, and testing data are accurate and reliable. |
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