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China medical GB Standards List

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  •  China "medical" GB Standards List:
    • China National Standards
    		GB/T 16895.24-2024 - English Version of China National Standard
    Low-voltage electrical installations-Part 7-710: Requirements for special installations or places- medical facilities {译}
    低压电气装置-第7-710部分：特殊装置或场所的要求-医疗场所 。
    China National Standards
    		GB/Z 44877-2024 - English Version of China National Standard
    Sterilization of medical devices - Guidelines for release of parameters for ethylene oxide sterilization processes {译}
    医疗器械灭菌-环氧乙烷灭菌过程参数放行指南 。
    China National Standards
    		GB/T 14233.3-2024 - English Version of China National Standard
    Test methods for medical infusion, transfusion and injection equipment - Part 3: Microbiological test methods {译}
    医用输液、输血、注射器具检验方法-第3部分：微生物学试验方法 。
    China National Standards
    		GB/T 44585.1-2024 - English Version of China National Standard
    Application of risk management in medical devices connected to IT networks - Part 1: Safety, effectiveness and network security of networked medical devices or health software in their implementation and use {译}
    风险管理在接入IT网络的医疗器械中的应用-第1部分：联网医疗器械或健康软件在其实施和使用中的安全、有效性和网络安全 。
    China National Standards
    		GB/T 44586.1-2024 - English Version of China National Standard
    In vitro diagnostic medical devices-Multiple nucleic acid molecular detection-Part 1: Nucleic acid quality evaluation terms and general requirements {译}
    体外诊断医疗器械-多重核酸分子检测-第1部分：核酸质量评价术语和通用要求 。
    China National Standards
    		GB/T 44672-2024 - English Version of China National Standard
    In vitro diagnostic medical devices - Establishment of calibration products and human samples Requirements for internationally consistent schemes for assigning metrological traceability {译}
    体外诊断医疗器械-建立校准品和人体样品赋值计量溯源性的国际一致化方案的要求 。
    China National Standards
    		GB 16174.1-2024 - English Version of China National Standard
    Surgical implants-Active implantable medical devices-Part 1: General requirements for safety, marking and information provided by manufacturers {译}
    手术植入物-有源植入式医疗器械-第1部分：安全、标记和制造商所提供信息的通用要求 。
    China National Standards
    		GB 16174.2-2024 - English Version of China National Standard
    Surgical implants-Active implantable medical devices-Part 2: Pacemakers {译}
    手术植入物-有源植入式医疗器械-第2部分：心脏起搏器 。
    China National Standards
    		GB/Z 44363-2024 - English Version of China National Standard
    Pyrogenicity - Principles and methods of pyrogenicity testing for medical devices {译}
    致热性-医疗器械热原试验的原理和方法 。
    China National Standards
    		GB/T 44353.2-2024 - English Version of China National Standard
    medical devices of animal origin - Part 2: Control of source, collection and disposal {译}
    动物源医疗器械-第2部分：来源、收集与处置的控制 。
    China National Standards
    		GB/T 44353.1-2024 - English Version of China National Standard
    medical devices of animal origin - Part 1: Risk management application - {译}
    动物源医疗器械-第1部分：风险管理应用- 。
    China National Standards
    		GB/T 16886.10-2024 - English Version of China National Standard
    Biological evaluation of medical devices - Part 10: Skin sensitization test {译}
    医疗器械生物学评价-第10部分：皮肤致敏试验 。
    China National Standards
    		GB/T 18457-2024 - English Version of China National Standard
    Stainless steel needles for medical devices - Requirements and test methods {译}
    制造医疗器械用不锈钢针管-要求和试验方法 。
    China National Standards
    		GB/T 44059.1-2024 - English Version of China National Standard
    medical gas pipeline systems - Part 1: - Pipe systems for compressed medical gases and vacuum {译}
    医用气体管道系统-第1部分:-压缩医用气体和真空用管道系统 。
    China National Standards
    		GB/T 43952-2024 - English Version of China National Standard
    medical supply devices {译}
    医用供应装置 。
    China National Standards
    		GB/T 19633.2-2024 - English Version of China National Standard
    Terminally sterilized medical device packaging - Part 2: Requirements for confirmation of molding, sealing and assembly processes {译}
    最终灭菌医疗器械包装-第2部分：成型、密封和装配过程的确认的要求 。
    China National Standards
    		GB/T 19633.1-2024 - English Version of China National Standard
    Terminally sterilized medical device packaging - Part 1: Requirements for materials, sterile barrier systems and packaging systems {译}
    最终灭菌医疗器械包装-第1部分：材料、无菌屏障系统和包装系统的要求 。
    China National Standards
    		GB-1588-2024 - English Version of China National Standard
    medical glass thermometers {译}
    医用玻璃体温计 。
    China National Standards
    		GB/T 43980-2024 - English Version of China National Standard
    Interpretation services - medical interpretation requirements {译}
    口译服务-医疗口译要求 。
    China National Standards
    		GB/T 44008-2024 - English Version of China National Standard
    General Technical Requirements for Emergency medical Modular Integrated Systems {译}
    应急医用模块化集成系统通用技术要求 。
    China National Standards
    		GB 19083-2023 - English Version of China National Standard
    medical protective mask {译}
    医用防护口罩 。
    China National Standards
    		GB 19082-2023 - English Version of China National Standard
    medical disposable protective clothing {译}
    医用一次性防护服 。
    China National Standards
    		GB/Z 43280-2023 - English Version of China National Standard
    medical Laboratory Measurement Uncertainty Assessment Guide {译}
    医学实验室 测量不确定度评定指南 。
    China National Standards
    		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 。
    China National Standards
    		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 。
    China National Standards
    		GB/T 43312-2023 - English Version of China National Standard
    Wire rope for medical equipment {译}
    医疗器械用钢丝绳 。
    China National Standards
    		GB/T 43278-2023 - English Version of China National Standard
    medical Laboratory Risk Management Application in Medical Laboratory {译}
    医学实验室 风险管理在医学实验室的应用 。
    China National Standards
    		GB/T 43277.2-2023 - English Version of China National Standard
    Stop clamps and flow regulators for medical infusion (blood transfusion) equipment Part 2: Liquid contact scale flow regulators {译}
    医用输液（输血）器具用止流夹和流量调节器 第2部分：液体接触式刻度流量调节器 。
    China National Standards
    		GB/T 43277.1-2023 - English Version of China National Standard
    Stop clamps and flow regulators for medical infusion (blood transfusion) equipment Part 1: Non-liquid contact stop clamps and flow regulators {译}
    医用输液（输血）器具用止流夹和流量调节器 第1部分：非液体接触式止流夹和流量调节器 。
    China National Standards
    		GB/T 19042.6-2023 - English Version of China National Standard
    Evaluation and routine testing of medical imaging departments Part 3-6: Imaging performance acceptance and stability testing of mammography X-ray equipment in breast tomosynthesis imaging mode {译}
    医用成像部门的评价及例行试验 第3-6部分:乳腺断层合成成像模式下乳腺摄影X射线设备成像性能验收与稳定性试验 。

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