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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. |
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| GB/T 16895.24-2024 |
Low-voltage electrical installations-Part 7-710: Requirements for special installations or places- medical facilities 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 medical |
 English PDF |
| GB/Z 44877-2024 |
Sterilization of medical devices - Guidelines for release of parameters for ethylene oxide sterilization processes 医疗器械灭菌-环氧乙烷灭菌过程参数放行指南 |
China National Standards medical |
English PDF |
| GB/T 14233.3-2024 |
Test methods for medical infusion, transfusion and injection equipment - Part 3: Microbiological test methods 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 medical |
English PDF |
| GB/T 44585.1-2024 |
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 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 medical |
English PDF |
| GB/T 44586.1-2024 |
In vitro diagnostic medical devices-Multiple nucleic acid molecular detection-Part 1: Nucleic acid quality evaluation terms and general requirements 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 medical |
English PDF |
| GB/T 44672-2024 |
In vitro diagnostic medical devices - Establishment of calibration products and human samples Requirements for internationally consistent schemes for assigning metrological traceability 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 medical |
English PDF |
| GB 16174.1-2024 |
Surgical implants-Active implantable medical devices-Part 1: General requirements for safety, marking and information provided by manufacturers 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 medical |
English PDF |
| GB 16174.2-2024 |
Surgical implants-Active implantable medical devices-Part 2: Pacemakers 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 medical |
English PDF |
| GB/Z 44363-2024 |
Pyrogenicity - Principles and methods of pyrogenicity testing for medical devices 致热性-医疗器械热原试验的原理和方法 |
China National Standards medical |
English PDF |
| GB/T 44353.2-2024 |
medical devices of animal origin - Part 2: Control of source, collection and disposal 动物源医疗器械-第2部分：来源、收集与处置的控制 |
China National Standards medical |
English PDF |
| GB/T 44353.1-2024 |
medical devices of animal origin - Part 1: Risk management application - 动物源医疗器械-第1部分：风险管理应用- |
China National Standards medical |
English PDF |
| GB/T 16886.10-2024 |
Biological evaluation of medical devices - Part 10: Skin sensitization test 医疗器械生物学评价-第10部分：皮肤致敏试验 |
China National Standards medical |
English PDF |
| GB/T 18457-2024 |
Stainless steel needles for medical devices - Requirements and test methods 制造医疗器械用不锈钢针管-要求和试验方法 |
China National Standards medical |
English PDF |
| GB/T 44059.1-2024 |
medical gas pipeline systems - Part 1: - Pipe systems for compressed medical gases and vacuum 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 medical |
English PDF |
| GB/T 43952-2024 |
medical supply devices 医用供应装置 |
China National Standards medical |
English PDF |
| GB/T 19633.2-2024 |
Terminally sterilized medical device packaging - Part 2: Requirements for confirmation of molding, sealing and assembly processes 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 medical |
English PDF |
| GB/T 19633.1-2024 |
Terminally sterilized medical device packaging - Part 1: Requirements for materials, sterile barrier systems and packaging systems 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 medical |
English PDF |
| GB-1588-2024 |
medical glass thermometers 医用玻璃体温计 |
China National Standards medical |
English PDF |
| GB/T 43980-2024 |
Interpretation services - medical interpretation requirements 口译服务-医疗口译要求 |
China National Standards medical |
English PDF |
| GB/T 44008-2024 |
General Technical Requirements for Emergency medical Modular Integrated Systems 应急医用模块化集成系统通用技术要求 |
China National Standards medical |
English PDF |
| GB 19083-2023 |
medical protective mask 医用防护口罩 |
China National Standards medical |
English PDF |
| GB 19082-2023 |
medical disposable protective clothing 医用一次性防护服 |
China National Standards medical |
English PDF |
| GB/Z 43280-2023 |
medical Laboratory Measurement Uncertainty Assessment Guide 医学实验室 测量不确定度评定指南 |
China National Standards medical |
English PDF |
| GB/T 16886.23-2023 |
Biological evaluation of medical devices Part 23: Stimulation test 医疗器械生物学评价 第23部分：刺激试验 |
China National Standards medical |
English PDF |
| GB/T 16886.12-2023 |
Biological Evaluation of medical Devices Part 12: Sample Preparation and Reference Materials 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 medical |
English PDF |
| GB/T 43312-2023 |
Wire rope for medical equipment 医疗器械用钢丝绳 |
China National Standards medical |
English PDF |
| GB/T 43278-2023 |
medical Laboratory Risk Management Application in Medical Laboratory 医学实验室 风险管理在医学实验室的应用 |
China National Standards medical |
English PDF |
| GB/T 43277.2-2023 |
Stop clamps and flow regulators for medical infusion (blood transfusion) equipment Part 2: Liquid contact scale flow regulators 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 medical |
English PDF |
| GB/T 43277.1-2023 |
Stop clamps and flow regulators for medical infusion (blood transfusion) equipment Part 1: Non-liquid contact stop clamps and flow regulators 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 medical |
English PDF |
| GB/T 19042.6-2023 |
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 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 |
China National Standards medical |
English PDF |
| GB 29923-2023 |
National Food Safety Standard Good Manufacturing Practice for Formulas for Special medical Purposes 食品安全国家标准 特殊医学用途配方食品良好生产规范 |
China National Standards medical |
English PDF |
| GB 18279-2023 |
Sterilization of healthcare products Ethylene oxide Requirements for the development, validation and routine control of medical device sterilization processes 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 |
China National Standards medical |
English PDF |
| GB/T 13797-2023 |
General technical requirements for medical X-ray tubes 医用X射线管通用技术条件 |
China National Standards medical |
English PDF |
| GB 9706.204-2022 |
medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators 医用电气设备 第2-4部分：心脏除颤器的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB/T 41659-2022 |
General technical requirements for building medical doors 建筑用医用门通用技术要求 |
China National Standards medical |
English PDF |
| GB/T 16886.6-2022 |
Biological evaluation of medical devices Part 6: local response test after implantation 医疗器械生物学评价 第6部分：植入后局部反应试验 |
China National Standards medical |
English PDF |
| GB/T 16886.4-2022 |
Biological evaluation of medical devices - Part 4: selection of interaction test with blood 医疗器械生物学评价 第4部分：与血液相互作用试验选择 |
China National Standards medical |
English PDF |
| GB/T 16886.1-2022 |
Biological evaluation of medical devices Part 1: evaluation and testing in the process of risk management 医疗器械生物学评价 第1部分：风险管理过程中的评价与试验 |
China National Standards medical |
English PDF |
| GB 9706.222-2022 |
medical electrical equipment - Part 2-22: Particular requirements for the basic safety and essential performance of laser equipment for surgical, orthopedic, therapeutic and diagnostic use 医用电气设备 第2-22部分：外科、整形、治疗和诊断用激光设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB/T 16886.19-2022 |
Biological evaluation of medical devices - Part 19: Physicochemical, morphological and surface characterization of materials 医疗器械生物学评价 第19部分：材料物理化学、形态学和表面特性表征 |
China National Standards medical |
English PDF |
| GB/T 16886.18-2022 |
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials in the risk management process 医疗器械生物学评价 第18部分：风险管理过程中医疗器械材料的化学表征 |
China National Standards medical |
English PDF |
| GB/T 16886.15-2022 |
Biological Evaluation of medical Devices-Part 15: Qualitative and Quantitative Degradation Products of Metals and Alloys 医疗器械生物学评价 第15部分：金属与合金降解产物的定性与定量 |
China National Standards medical |
English PDF |
| GB/T 16886.9-2022 |
Biological evaluation of medical devices - Part 9: Qualitative and quantitative framework for potential degradation products 医疗器械生物学评价 第9部分：潜在降解产物的定性和定量框架 |
China National Standards medical |
English PDF |
| GB/Z 16886.22-2022 |
Biological Evaluation of medical Devices Part 22: Guidelines for Nanomaterials 医疗器械生物学评价 第22部分：纳米材料指南 |
China National Standards medical |
English PDF |
| GB/Z 42217-2022 |
medical devices for the validation of medical device quality system software 医疗器械 用于医疗器械质量体系软件的确认 |
China National Standards medical |
English PDF |
| GB/T 42218-2022 |
Laboratory medicine - In vitro diagnostic medical devices - Manufacturer's confirmation of quality control procedures provided to users 检验医学 体外诊断医疗器械 制造商对提供给用户的质量控制程序的确认 |
China National Standards medical |
English PDF |
| GB/T 42204-2022 |
Clinical medical equipment communication specification Imaging equipment 临床医疗设备通信规范 影像设备 |
China National Standards medical |
English PDF |
| GB/T 42186-2022 |
Operational Specifications for Cold Chain Logistics of Biological Samples for medical Testing 医学检验生物样本冷链物流运作规范 |
China National Standards medical |
English PDF |
| GB 9706.255-2022 |
medical electrical equipment - Part 2-55: Particular requirements for basic safety and essential performance of respiratory gas monitors 医用电气设备 第2-55部分：呼吸气体监护仪的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.275-2022 |
medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment 医用电气设备 第2-75部分：光动力治疗和光动力诊断设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.271-2022 |
medical electrical equipment - Part 2-71: Particular requirements for basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment 医用电气设备 第2-71部分：功能性近红外光谱(NIRS)设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.283-2022 |
medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of household phototherapy equipment 医用电气设备 第2-83部分：家用光治疗设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.290-2022 |
medical electrical equipment - Part 2-90: Particular requirements for the basic safety and essential performance of high-flow respiratory therapy equipment 医用电气设备 第2-90部分：高流量呼吸治疗设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB/T 42060-2022 |
medical laboratories - Requirements for sample collection, shipping, receipt and handling 医学实验室 样品采集、运送、接收和处理的要求 |
China National Standards medical |
English PDF |
| GB/T 42067-2022 |
Water-soluble biodegradable medical fabric packaging film bag 水溶性生物降解医用织物包装膜袋 |
China National Standards medical |
English PDF |
| GB/T 42062-2022 |
medical Devices Application of Risk Management to Medical Devices 医疗器械 风险管理对医疗器械的应用 |
China National Standards medical |
English PDF |
| GB/T 14233.1-2022 |
Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods 医用输液、输血、注射器具检验方法 第1部分：化学分析方法 |
China National Standards medical |
English PDF |
| GB/T 19042.5-2022 |
Evaluation and routine tests in medical imaging sector - Part 3-5: X-ray computed tomography equipment imaging performance acceptance test and stability test 医用成像部门的评价及例行试验 第3-5部分：X射线计算机体层摄影设备成像性能验收试验与稳定性试验 |
China National Standards medical |
English PDF |
| GB/T 42061-2022 |
medical device quality management system for regulatory requirements 医疗器械 质量管理体系 用于法规的要求 |
China National Standards medical |
English PDF |
| GB 9706.208-2021 |
medical electrical equipment –Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV 医用电气设备 第2-8部分：能量为10kV至1MV 治疗X射线设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.216-2021 |
medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment 医用电气设备 第2-16部分：血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.229-2021 |
medical electrical equipment—Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators 医用电气设备 第2-29部分：放射治疗模拟机的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.239-2021 |
medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment 医用电气设备 第2-39部分：腹膜透析设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.265-2021 |
medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment 医用电气设备 第2-65部分：口内成像牙科X射线机的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.243-2021 |
medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures 医用电气设备 第2-43部分：介入操作X射线设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.239-2021 |
medical electrical equipment—Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment 医用电气设备 第2-39部分：腹膜透析设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.229-2021 |
medical electrical equipment—Part 2-29:Particular requirements for the basic safety and essential performance of radiotherapy simulators 医用电气设备 第2-29部分：放射治疗模拟机的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.216-2021 |
medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment 医用电气设备 第2-16部分：血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.208-2021 |
medical electrical equipment—Part 2-8:Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV 医用电气设备 第2-8部分：能量为10kV至1MV 治疗X射线设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB/T 22576.7-2021 |
medical laboratories—Requirements for quality and competence—Part 7：Requirements in the field of transfusion medicine 医学实验室 质量和能力的要求 第7部分：输血医学领域的要求 |
China National Standards medical |
English PDF |
| GB/T 22576.6-2021 |
medical laboratories—Requirements for quality and competence—Part 6: Requirements in the field of clinical microbiological examination 医学实验室 质量和能力的要求 第6部分：临床微生物学检验领域的要求 |
China National Standards medical |
English PDF |
| GB/T 22576.5-2021 |
medical laboratories-Requirements for quality and competence- Part 5:Requirements in the field of clinical immunology examination 医学实验室 质量和能力的要求 第5部分：临床免疫学检验领域的要求 |
China National Standards medical |
English PDF |
| GB/T 22576.4-2021 |
medical laboratories-Requirements for quality and competence- Part 4:Requirements in the field of clinical chemistry examination 医学实验室 质量和能力的要求 第4部分：临床化学检验领域的要求 |
China National Standards medical |
English PDF |
| GB/T 22576.3-2021 |
medical laboratories-Requirements for quality and competence-Part 3:Requirements in the field of urine examination 医学实验室 质量和能力的要求 第3部分：尿液检验领域的要求 |
China National Standards medical |
English PDF |
| GB/T 22576.2-2021 |
medical laboratories-Requirements for quality and competence- Part 2:Requirements in the field of clinical hematological examination 医学实验室 质量和能力的要求 第2部分：临床血液学检验领域的要求 |
China National Standards medical |
English PDF |
| GB/T 40028.2-2021 |
Smart city—Smart medical—Part 2：Mobile health 智慧城市 智慧医疗 第2部分：移动健康 |
China National Standards medical |
English PDF |
| GB/T 19702-2021 |
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures 体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求 |
China National Standards medical |
English PDF |
| GB/T 10001.6-2021 |
Public information graphical symbols—Part 6: Symbols for medical treatment and health care 公共信息图形符号 第6部分：医疗保健符号 |
China National Standards medical |
English PDF |
| GB 9706.218-2021 |
medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment 医用电气设备 第2-18部分：内窥镜设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.236-2021 |
medical electrical equipment—Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy 医用电气设备 第2-36部分：体外引发碎石设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.225-2021 |
medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs 医用电气设备 第2-25部分：心电图机的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.224-2021 |
medical electrical equipment—Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers 医用电气设备 第2-24部分：输液泵和输液控制器的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.213-2021 |
medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation 医用电气设备 第2-13部分：麻醉工作站的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.202-2021 |
medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 医用电气设备 第2-2部分：高频手术设备及高频附件的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 30035-2021 |
Criteria of medical examination for seafarers 船员健康检查要求 |
China National Standards medical |
English PDF |
| GB/T 40939-2021 |
General requirements for low temperature medical cold store 低温医用冷库通用技术要求 |
China National Standards medical |
English PDF |
| GB/T 16886.16-2021 |
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables 医疗器械生物学评价 第16部分：降解产物与可沥滤物毒代动力学研究设计 |
China National Standards medical |
English PDF |
| GB/T 16886.11-2021 |
Biological evaluation of medical devices—Part 11:Tests for systemic toxicity 医疗器械生物学评价 第11部分：全身毒性试验 |
China National Standards medical |
English PDF |
| GB/T 16751.2-2021 |
Clinic terminology of traditional Chinese medical diagnosis and treatment -- Part 2: Syndromes/patterns 中医临床诊疗术语 第2部分：证候 |
China National Standards medical |
English PDF |
| GB 9706.227-2021 |
medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 医用电气设备 第2-27部分：心电监护设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.226-2021 |
medical electrical equipment—Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs 医用电气设备 第2-26部分：脑电图机的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.219-2021 |
medical electrical equipment—Part 2-19:Particular requirements for the basic safety and essential performance of infant incubators 医用电气设备 第2-19部分：婴儿培养箱的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB/T 40670-2021 |
Guidelines for establishment and development of traditional Chinese medical thesauri 中医药学主题词表编制规则 |
China National Standards medical |
English PDF |
| GB 39707-2020 |
Standard for pollution control on medical waste treatment and disposal 医疗废物处理处置污染控制标准 |
China National Standards medical |
English PDF |
| GB 9706.254-2020 |
medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 医用电气设备 第2-54部分：X射线摄影和透视设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.260-2020 |
medical electrical equipment—Part 2-60: Paticular requirments for the basic safety and essential performance of dental equipment 医用电气设备 第2-60部分：牙科设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.263-2020 |
medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment 医用电气设备 第2-63部分: 口外成像牙科X射线机基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.205-2020 |
medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment 医用电气设备 第2-5部分：超声理疗设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.206-2020 |
medical electrical equipment—Part 2-6: Particular requirments for the basic safety and essential performence of microwave therapy equipment 医用电气设备 第2-6部分：微波治疗设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
| GB 9706.203-2020 |
medical electrical equipment—Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment 医用电气设备 第2-3部分：短波治疗设备的基本安全和基本性能专用要求 |
China National Standards medical |
English PDF |
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