YY/T 1454-2016.General requirements for in vitro diagnostic medical devices for self-testing. YY/T 1454规定了自我检测(以下简称自测)用体外诊断医疗器械的设计原则、制造商提供的标记和信息、性能评估、

YY/T 1434-2016.Medical devices for human in vitro assisted reproductive technology-In vitro mouse embryo assay. 4.3.1.2对照组准备 a)阳性对 照组 所使用的阳性对照品应经方法学验证

YY/T 1427-2016/ISO 16428 :2005.Implants for surgery- -Test solutions and environmental condition for static and dynamic corrosion tests on implantable

YY/T 1292.4-2017.Test for reproductive and developmental toxicity of medical devices-Part 4:Two-generation reproductive toxicity test. YY/T 1292的本部分给出

YY/T 1532-2017.Biological evaluation of medical devices-Nanomaterials-Hemolysis test. 7.5血液样晶的制 备 收集成年健康家兔的新鲜抗凝全血5 mL(采用3.8%柠檬酸三钠溶液1 : 9稀释)于试管中,取其中2 m

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/T 1292.1-2015.Test for reproductive and developmental toxicity of medical devices-Part 1: Screening test. 5试验基本原则 5.1 離性动物在整个试验中. 都应持续给予供试物。这包括交配前期

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

YY/T 1592-2018.ABO forward blood grouping and RhD typing reagents (column agglutination technique ,CAT). YY/T 1592规定了ABO正定型和RhD血型定型检测卡(柱凝集法)的要求.试验方法.标