《高原环境医疗器械贮存技术规范》地方标准制定探究

Research on the Development ofLocal Standard Technical specification for the storage of medical devices in plateau environments

LEI Di1.2.3 REN Jian1.2.3 LIU Hai-qing1.2.3 ZHANG Min-juan1.2.3 SUN Xiao-ning1.2.3 CHEN Yue-rong1.2.3 ZHAO Zhi-jie1.2.3 ZHANG Hong-tao1.2.3 LONG Cun-lin1.2.3* （1.QinghaiProvincial Drug InspectionandTesting Institute;2.QinghaiMedical Device Testing Engineering Technology Research Center; 3.Qinghai Province Medical Device Quality Control and Risk Assessment Key Laboratory） Abstract：This paper focuses onthedevelopmentoflocalstandardTechnical specification forthestorageofmedical devices in plateau environments，and deeply explores itsdevelopment background，significance，feasibility，and specific content.By analyzing the impact of the plateau environment on the performance and quality of medical devices，this paper expounds on the importantroleof this standard in ensuring medical qualityand safety，improving the accessibility of medicalservices，and other aspects.The paper further demonstrates the feasibilityof the project approval from thedimensions of technical research foundation，practical experience reference，industrycooperation and support，technological means advancement，and policysupport.The key technical contents of the standard such as generalrequirements forstorage，environmentalconditions，facilitiesand equipment，and personnelmanagement， areinterpretedindetail，imingtoprovideatheoreticalbasisandpractical guidanceforthestandardizedandsientifc storage ofmedical devices in plateauareas，and to promote the developmentof the medicaland healthcare services in plateauareas.

Keywords：plateau environment，storageof medical devices，technical specification，medicalquality，industry development

0 引言

高原环境具有低氧、低温、低气压、强紫外线以及较大昼夜温差等独特环境特征，这些因素给医疗器械的贮存带来诸多挑战。（剩余4880字）