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目的根据医学实验室仪器设备使用特点和方式,对计量部门出具的校准证书的完整性、校准结果是否达到策划的要求以及仪器设备是否能够投入使用等方面,医学实验室都需仪器校准后做结果确认,仪器设备满足预期要求后,可以正常使用。方法采用仪器设备的最大示值误差不超过其最大允许误差或仪器设备的实际值测量不确定度不超过其最大允许误差两种方法来评定。结果依据检验方法技术规范、仪器的使用说明书、与生产厂家签订的技术协议等技术文件。给出确认结果:符合或不符合。结论医学实验室应重视和规范仪器设备校准结果的确认,将固定的确认方法灵活使用在实际工作中,提高仪器设备量值溯源规范性管理。
Objective According to the characteristics and methods of using medical laboratory equipment and instruments, the calibration certificate issued by the measurement department is complete, whether the calibration results meet the planning requirements and whether the equipment can be put into use, etc. Confirm that the equipment can meet the expected requirements, it can be used normally. Methods The maximum indication error of instrumentation equipment does not exceed its maximum allowable error or the actual value of instrumentation equipment measurement uncertainty does not exceed the maximum allowable error of two ways to assess. Results based on test methods and technical specifications, the instrument manual, and the manufacturer signed a technical agreement and other technical documents. Give the confirmation result: Yes or No. Conclusion Medical laboratories should pay attention to and standardize the confirmation of the calibration results of equipment and instruments, use the fixed confirmation methods flexibly in practical work, and improve the standard management of the traceability of equipment and equipment.