GOST R ISO TR 14969-2007 Medical devices Quality management systems Guidance on the application of ISO 13485 2003《医疗器械 质量管理体系 ISO 13485 2003的应用指南》.pdf

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YY T 0681.1-2009 无菌医疗器械包装试验方法 第1部分 加速老化试验指南.pdf

YY T 0681.2-2010 无菌医疗器械包装试验方法 第2部分：软性屏障材料的密封强度.pdf

YY T 0681.3-2010 无菌医疗器械包装试验方法 第3部分：无约束包装抗内压破坏.pdf

YY T 0681.4-2010 无菌医疗器械包装试验方法 第4部分：染色液穿透法测定透气包装的密封泄漏.pdf

GB T 21415-2008 体外诊断医疗器械生物样品中量的测量 校准品和控制物质赋值的计量学溯源性.pdf

JIS T0307-2004 医疗器械.用于医疗器械标签、作标记和提供信息的符号.pdf

JIS Q13485-2005 医疗器械.质量管理系统.管理目标的要求.pdf

BB T 0059-2012 医疗器械吸塑包装用共挤膜.pdf

SN T 1430.1-2004 进口医疗器械检验规程医用超声诊断和治疗设备.pdf

WS T 118-1999 全国卫生行业医疗器械、仪器设备（商品、物资）分类与代码.pdf

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