医学实验室仪器设备检定和校准修正因子的使用方法

The Application of Correction Factors Generated During the Verification and Calibration of Medical Laboratory Instruments and Equipments

国家卫生健康委员会、国家市场监督管理总局和中国合格评定国家认可委员会均明确要求对医疗器械定期检查、检验和校准,对部分计量器具实施强制检定,以满足临床应用需要,保证其使用质量。检定、校准或计量机构对仪器设备进行校准后,通常会给出一组校准因子或修正因子。实验室应确保该参考值和修正因子得到适当的更新和应用,以满足规定要求。本文针对医学实验室工作人员在如何正确使用修正因子/修正值存在的困惑,结合医学实验室实际,对检定和校准的概念、国家和相关职能部门对医疗器械检定和校准的要求、修正因子和修正值的获取方式以及修正因子/修正值的采用、计算和正确使用方法进行了报道。

The National Health Commission,the State Administration for Market Regulation and the China National Accreditation Service for Conformity Assessment all officially require regular inspection,verification or calibration of medical instrument and equipment,and a mandatory verification of selected measuring instruments to meet the needs of clinical applications and ensure the quality of their clinical applications.A set of calibration factors or verification factors are usually generated after the calibration and verify cation by the organizations that calibrating or verifying the medical equipment.The laboratory shall ensure that these reference values and correction factors are appropriately updated and applied to meet specified requirements.This article aims to clarify the confusions of medical laboratory staff could have on how to correctly use the correction factor/correction value.Combined with the medical laboratory circumstances,the concept of verification and calibration,the requirements of the state and relevant functional departments for the verification and calibration of medical devices are introduced.The correction factors and the methods of obtaining the correction values and the adoption,the calculation and correct use of the correction factors/correction values are also reported.