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目的对注射液中可见异物检查的新旧标准进行比较,评价新老标准的优点与不足。方法新老标准灯检法对比。结果修改后的新标准避免了旧标准中生产企业灯检人员与药监人员在执行标准上的差异。结论新标准对2毫米为界的异物判定,人的主观因素影响仍较多,建议相关部门在修订注射液中可见异物检查标准时予以修改和完善。
Objective To compare the old and new standards of foreign bodies in the injection and evaluate the advantages and disadvantages of the old and new standards. Comparison of new and old standard lamp test methods. The results of the revised new standards to avoid the old standards of production enterprises and medical inspectors seized the staff in the implementation of the standard differences. Conclusion The new standard on the 2 mm boundary of the foreign body to determine the subjective factors of human influence is still more recommended that the relevant departments in the revision of the injection of foreign matter inspection standards be modified and improved.