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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 18279-2023 - English Version of China National Standard Sterilization of healthcare products Ethylene oxide Requirements for the development, validation and routine control of medical device sterilization processes {译} 医疗保健产品灭菌 环氧乙烷 医疗器械灭菌过程的开发、确认和常规控制要求 。 |
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GB/T 13797-2023 - English Version of China National Standard General technical requirements for medical X-ray tubes {译} 医用X射线管通用技术条件 。 |
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YY 0601-2009 - English Version of China Pharmaceutics Industry Standard medical electrical equipment - Particular requirements for basic safety and main performance of respiratory gas monitors {译} 医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求 。 |
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YY 0068.4-2009 - English Version of China Pharmaceutics Industry Standard medical endoscopes - Rigid endoscopes - Part 4: Basic requirements {译} 医用内窥镜 硬性内窥镜 第4部分：基本要求 。 |
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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 0841-2011 - English Version of China Pharmaceutics Industry Standard medical electrical equipment Periodic testing and post-repair testing of medical electrical equipment {译} 医用电气设备 医用电气设备周期性测试和修理后测试 。 |
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YY/T 91051-1999 - English Version of China Pharmaceutics Industry Standard medical device industry standard system table {译} 医疗器械行业标准体系表 。 |
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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 0770.2-2009 - English Version of China Pharmaceutics Industry Standard Filter materials for medical infusion and injection equipment - Part 2: Air filter materials {译} 医用输液、注器具用过滤材料 第2部分：空气过滤材料 。 |
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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 0507-2009 - English Version of China Pharmaceutics Industry Standard medical elastic bandage - Characterization of basic performance parameters and test methods {译} 医用弹性绷带 基本性能参数表征及试验方法 。 |
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YY/T 0865.1-2011 - English Version of China Pharmaceutics Industry Standard Ultrasound - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz {译} 超声 水听器 第1部分：40MHz 以下医用超声场的测量和特征描绘 。 |
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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 0840-2011 - English Version of China Pharmaceutics Industry Standard medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance {译} 医用电气设备 放射性核素校准仪 描述性能的专用方法 。 |
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YY/T 0863-2011 - English Version of China Pharmaceutics Industry Standard medical endoscope, endoscope function supply device, rolling flushing suction device {译} 医用内窥镜 内窥镜功能供给装置 滚压式冲洗吸引器 。 |
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YY/T 0842-2011 - English Version of China Pharmaceutics Industry Standard medical endoscope Endoscope accessories Mirror sheath {译} 医用内窥镜 内窥镜附件 镜鞘 。 |
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YY/T 0864-2011 - English Version of China Pharmaceutics Industry Standard medical endoscope, endoscope function supply device, liquid expansion cavity pump {译} 医用内窥镜 内窥镜功能供给装置 液体膨腔泵 。 |
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YY/T 0763-2009 - English Version of China Pharmaceutics Industry Standard Optical cable for medical endoscope lighting {译} 医用内窥镜 照明用光缆 。 |
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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 1894-2023 - English Version of China Pharmaceutics Industry Standard Verification method for reliability index of medical magnetic resonance equipment {译} 医用磁共振设备可靠性指标验证方法 。 |
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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/T 1437-2023 - English Version of China Pharmaceutics Industry Standard medical Device GB/T 42062 Application Guide {译} 医疗器械 GB/T 42062应用指南 。 |
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YY/T 0907-2023 - English Version of China Pharmaceutics Industry Standard Needle-free syringes for medical use Requirements and test methods {译} 医用无针注射器 要求及试验方法 。 |
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YY 1887-2023 - English Version of China Pharmaceutics Industry Standard medical positive pressure protective clothing {译} 医用正压防护服 。 |
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YY 1881-2023 - English Version of China Pharmaceutics Industry Standard medical positive pressure air-supply respirator {译} 医用正压送风式呼吸器 。 |
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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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