YY/T 0468-2003/ISO 15225: 2000.Nomenclature-Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange. Y

YY/T 0638-2008/ISO 18153 :2003.In vitro diagnostic medical devices- Measurement of quantities in biological samples-Metrological traceability of assig

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 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 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

YY/T 0995-2015.Medical devices for human assisted reproductive technology-Terminology and definitions. YY/T 0995规定了人类辅助生殖技术中的体外受精胚胎移植技术及其衍生技术所使用的医疗器械的

YY/T 1597-2017.Neonatal phenylalanine testing kit. 4.7稳定性 4.7.1总则:可对效期稳定性和热稳定性进行验证。 4.7.2效期稳定性 :生产企业应规定产品的有效期。取到效期后一定时间内的产品检测试剂，线性区间、准确度.特异性、空白限、精密度应符

YY 0970-2013/ISO 14160: 1998.Sterilization of single- use medical devices incorporating materials of animal origin- Validation and routine control of

YY/T 1555.2-2018.Particular requirements for the silicone gel filled breast implant-Performance requirement of silicone gel filler-Part 2 :Limits requ