YY 0670-2008.Non-invasive automated sphygmomanometer. YY 0670规定了所有使用阻塞袖带对人体进行间接动脉血压测量的自动的、电子的动脉血压计的安全性和有效性的要求。 1.1本标准包括的设备 YY 0670适用于利用示波法或类似的其他方法来完成无

YY/T 0870.1-2013.Test for genotoxicity of medical devices-Part 1 :Bacterial reverse mutation test. 6.3.2.2接种:取有组氨酸和无组氨酸培养基平皿各一个，按菌株号顺序各取-白金耳菌液划线(直线)接种

YY/T 0879.1-2013.Test for sensitization of medical devices-Part 1:Murine local lymph node assay (LLNA) : Radioisotope incorporation method. 5试验样品的制备 5

YY/T 0869-2013/ISO/TS 19218 :2005.Medical devices-Coding structure for adverse event type and cause. YY/T 0869规定了措述医疗器械不良事件的编码结构的要求。本编码预期为医疗器械用户、制造商和管

YY/T 0313-2014.Medical polymer products-Requirement for package and information supplied by manufacturer. A类:耐挤压产品: B类:受挤压对其质量会有一- 定影响的产品; C类:受挤压对其质量会

YY/T 1465.5-2016.Immunogenic evaluation method of medical devices-Part 5: Determination of a-Gal antigen clearance in medical devices utilizing animal

YY/T 1292.3-2016.Test for reproductive/ developmental toxicity of medical devices-Part 3: One -generation reproductive toxicity test. 6.2.2数和性别 每一试验组和

YY/T 1465.2-2016.Immunogenic evaluation method of medical devices-Part 2 :Serum immunoglobulin and complement component detection (enzyme-linked immun

YY/T 1465.1-2016.Immunogenic evaluation method of medical devices一Part 1: T Lymphocyte transformation test in vitro. 5.2 动物的种属和要求 常用的实验动物为小鼠。本部分中推荐使用未

YY/T 1287.1-2016.Intracranial external drainage system-Part 1:Collecting sets for external drainage by intracranial puncture. YY/T1287的本部分规定了颅脑外引流系统中的