医疗器械抽检抽样检验方案范式的建立  

Establishment of Sampling Inspection Scheme Paradigm for Medical Device Sampling Inspection

作　　者：郝擎[1] 张欣涛[1] 朱炯[1] HAO Qing;ZHANG Xintao;ZHU Jiong(National Institutes for Food and Drug Control,Beijing,102629)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国医疗器械杂志》2019年第4期286-289,共4页Chinese Journal of Medical Instrumentation

摘　　要：该文介绍了组织医疗器械抽检时所遵循的抽样方案和检验方案范式。抽样方案范式包括对抽检产品的界定和实操指引,对单个抽样批的规定和与之相关的型号规格、附件资料、效期、贮存条件等的规定,对抽样区域场所和数量的要求,以及对样品送往检验机构的要求。检验方案范式则包括对检验依据、检验项目条款、判定原则等的规定。This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.

关 键 词：医疗器械 抽样 检验 范式 

分 类 号：F203[经济管理—国民经济] R197.39[医药卫生—卫生事业管理]