位置您的位置: 首页 > 信息公开 > 机构概况

无源医疗器械检测部Non-active Medical Devices Testing Department

发布时间:2021-03-03 文章来源: 深圳市药品检验研究院
分享到:

  主要从事无源医疗器械及药品包装材料的全性能检测及体内安全性评价实验及相关产品标准或技术要求的制定、修订、复核及检验新技术、新方法等研究工作;部门下设物理性能、化学性能和生物性能等3个专业实验室。拥有高级职称人员3人、博士1人、硕士8人;配有支架疲劳测试机、电感耦合等离子体质谱仪、液质联用仪、病理分析设备等大型精密仪器设备200余台套。近年来先后主持或参与完成生物学安全性评价、植入介入类产品及乳胶制品等多项国家标准、行业标准的制修订工作并完成国家、省、市各级各类科研课题二十余项。

  Non-active Medical Devices Testing Department mainly engaged in full properties testing and in vivo safety evaluation of medical device and pharmaceutical packaging materials, as well as formulation, revision, review and new technology testing of relevant product standards or technical requirements, and so on. The department consists of three professional laboratories, including physical properties, chemical properties and biological properties testing laboratory. The department includes three professional staffs with senior professional title, one PhD and eight masters. The department is equipped with more than 200 large-scale precision instruments and equipments, including bracket fatigue testing machine, inductively coupled plasma-mass spectrometry, liquid chromatography-mass spectrometry, pathological analysis equipments, and so on. In recent years, the department has successively presided over or participated in a number of formulating and revising work for national standards and industry standards such as biological safety evaluation, implantable and intervention products, and latex products. The department has accomplished more than twenty national, provincial and municipal scientific research projects.

  部门座右铭        提高技术 创新发展 服务产业 开创未来

附件: