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GB standards are the China national standards; Prefix code GB are Mandatory standards, GB/T are Recommended standards; All products or service must be compliance with GB standards; If you want to export products or services to huge Chinese market, need ensure they are meet the requirements of GB china national standards; We provide Chinese GB standards and English version GB standards Lookup, Translate, Download, Imported Commodity GB standards Testing and Compliance review services. |
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GB/T 43952-2024 - English Version of China National Standard Medical supply devices {译} 医用供应装置 。 |
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GB/T 16886.23-2023 - English Version of China National Standard Biological evaluation of Medical Devices Part 23: Stimulation test {译} 医疗器械生物学评价 第23部分：刺激试验 。 |
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GB/T 16886.12-2023 - English Version of China National Standard Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials {译} 医疗器械生物学评价 第12部分：样品制备与参照材料 。 |
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YY/T 1842.3—2023 - English Version of China Pharmaceutics Industry Standard Medical Devices - Connectors for medical liquid storage container delivery systems - Part 3: Gastrointestinal applications {译} 医疗器械 医用贮液容器输送系统用连接件 第3部分：胃肠道应用 。 |
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YY/T 0127.19—2023 - English Version of China Pharmaceutics Industry Standard Biological evaluation of oral Medical Devices Part 19: Subacute and subchronic systemic toxicity testing: Route of implantation {译} 口腔医疗器械生物学评价 第19部分：亚急性和亚慢性全身毒性试验：植入途径 。 |
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YY/T 0127.4—2023 - English Version of China Pharmaceutics Industry Standard Biological evaluation of oral Medical Devices Part 4: Bone implant test {译} 口腔医疗器械生物学评价 第4部分：骨植入试验 。 |
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SN/T 4445.4-2023 - English Version of China Import&Export Inspection Industry Standard Technical requirements for inspection of imported Medical Devices Part 4: Infusion pump {译} 进口医疗器械检验技术要求 第4部分：输液泵 。 |
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WS/T 364.16—2023 - English Version of China Hygiene Industry Standard Health information data element value field code Part 16: Drugs and Medical Devices {译} 卫生健康信息数据元值域代码 第16部分：药品与医疗器械 。 |
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WS/T 363.16—2023 - English Version of China Hygiene Industry Standard Health Information Data Meta Catalog Part 16: Drugs and Medical Devices {译} 卫生健康信息数据元目录 第16部分:药品与医疗器械 。 |
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YY/T 1914-2023 - English Version of China Pharmaceutics Industry Standard Medical Devices for human assisted reproductive technology - General requirements for device products {译} 人类辅助生殖技术用医疗器械 器具类产品通用要求 。 |
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YY/T 1912-2023 - English Version of China Pharmaceutics Industry Standard Biological evaluation and testing of Medical Devices for soft tissue regeneration {译} 用于软组织再生医疗器械的生物学评价与试验 。 |
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YY/T 1907-2023 - English Version of China Pharmaceutics Industry Standard Artificial Intelligence Medical Devices Coronary CT Image Processing Software Algorithm Performance Testing Methods {译} 人工智能医疗器械 冠状动脉CT影像处理软件 算法性能测试方法 。 |
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YY/T 1833.4-2023 - English Version of China Pharmaceutics Industry Standard Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 4: Traceability {译} 人工智能医疗器械 质量要求和评价 第4部分：可追溯性 。 |
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YY/T 0698.5—2023 - English Version of China Pharmaceutics Industry Standard Packaging materials for terminally sterilized Medical Devices Part 5: Sealable combination bags and rolls composed of breathable materials and plastic films Requirements and test methods {译} 最终灭菌医疗器械包装材料 第5部分：透气材料与塑料膜组成的可密封组合袋和卷材 要求和试验方法 。 |
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YY/T 0466.1—2023 - English Version of China Pharmaceutics Industry Standard Medical Devices Symbols for information provided by manufacturers Part 1: General requirements {译} 医疗器械 用于制造商提供信息的符号 第1部分：通用要求 。 |
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YY/T 0033-2000 - English Version of China Pharmaceutics Industry Standard Standards for Production Management of Sterile Medical Devices {译} 无菌医疗器具生产管理规范 。 |
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YY/T 0771.3-2009 - English Version of China Pharmaceutics Industry Standard Medical Devices of animal origin Part 3: Confirmation of removal and inactivation of viral and transmissible spongiform encephalopathy (TSE) agents {译} 动物源医疗器械 第3部分：病毒和传播性海绵状脑病（TSE）因子去除与灭活的确认 。 |
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YY/T 0127.16-2009 - English Version of China Pharmaceutics Industry Standard Biological Evaluation of Dental Medical Devices Unit 2: Test Methods Chromosomal Aberration Test of Mammalian Cells in Vitro {译} 口腔医疗器械生物学评价 第2单元：试验方法 哺乳动物细胞体外染色体畸变试验 。 |
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YY/T 0127.4-2009 - English Version of China Pharmaceutics Industry Standard Biological Evaluation of Dental Medical Devices Unit 2: Test Methods Bone Implant Test {译} 口腔医疗器械生物学评价 第2单元: 试验方法 骨埋植试验 。 |
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YY/T 0127.9-2009 - English Version of China Pharmaceutics Industry Standard Biological Evaluation of Dental Medical Devices Unit 2: Test Methods Cytotoxicity Test: Agar Diffusion Method and Membrane Diffusion Method {译} 口腔医疗器械生物学评价 第2单元：试验方法 细胞毒性试验:琼脂扩散法及滤膜扩散法 。 |
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YY/T 0770.1-2009 - English Version of China Pharmaceutics Industry Standard Filter materials for medical infusion and injection devices - Part 1: Filter materials for medicinal liquid {译} 医用输、注器具用过滤材料 第1部分：药液过滤材料 。 |
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YY/T 0590.3-2011 - English Version of China Pharmaceutics Industry Standard Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of quantum detection efficiency - Detectors for dynamic imaging {译} 医用电气设备 数字X射线成像装置特性 第1-3部分：量子探测效率的测定 动态成像用探测器 。 |
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YY/T 1899-2023 - English Version of China Pharmaceutics Industry Standard Preparation and evaluation methods of histopathological samples after implantation of absorbable Medical Devices {译} 可吸收医疗器械植入后组织病理学样本制备与评价方法 。 |
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YY/T 1897-2023 - English Version of China Pharmaceutics Industry Standard Biological evaluation of nanoMedical Devices Genotoxicity test In vitro mammalian cell micronucleus test {译} 纳米医疗器械生物学评价 遗传毒性试验 体外哺乳动物细胞微核试验 。 |
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YY/T 1754.3-2023 - English Version of China Pharmaceutics Industry Standard Preclinical Animal Studies of Medical Devices Part 3: Animal Model of Incisional Abdominal Hernia for Evaluation of Mesh Histological Response and Biomechanical Properties {译} 医疗器械临床前动物研究 第3部分：用于评价补片组织学反应与生物力学性能的动物腹壁切口疝模型 。 |
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YY 0989.3-2023 - English Version of China Pharmaceutics Industry Standard Surgical implants Active implantable Medical Devices Part 3: Implantable neurostimulators {译} 手术植入物 有源植入式医疗器械 第3部分：植入式神经刺激器 。 |
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YY/T 1295—2015 - English Version of China Pharmaceutics Industry Standard Biological Evaluation of Medical Devices Nanomaterials: Bacterial Endotoxin Test {译} 医疗器械生物学评价 纳米材料：细菌内毒素试验 。 |
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YY/T 1292.2—2015 - English Version of China Pharmaceutics Industry Standard Reproductive and Developmental Toxicity Tests for Medical Devices Part 2: Embryo Developmental Toxicity Tests {译} 医疗器械生殖和发育毒性试验 第2部分:胚胎发育毒性试验 。 |
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YY/T 1292.1—2015 - English Version of China Pharmaceutics Industry Standard Reproductive and Developmental Toxicity Tests for Medical Devices Part 1: Screening Tests {译} 医疗器械生殖和发育毒性试验 第1部分：筛选试验 。 |
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YY/T 1267—2015 - English Version of China Pharmaceutics Industry Standard Evaluation of Materials for Medical Devices Suitable for Ethylene Oxide Sterilization {译} 适用于环氧乙烷灭菌的医疗器械的材料评价 。 |
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