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China medical GB Standards English PDF List


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  •  China "medical" GB Standards English PDF List:
  • Standard  Code Standard Title Standard Class Order
    GB 9706.1-2020 medical electrical equipment—Part 1: General requirements for basic safety and essential performance
    医用电气设备 第1部分:基本安全和基本性能的通用要求
    China National Standards
    medical

    English PDF
    GB 9706.212-2020 medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    医用电气设备 第2-12部分:重症护理呼吸机的基本安全和基本性能专用要求
    China National Standards
    medical

    English PDF
    GB 9706.237-2020 medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    医用电气设备 第2-37部分:超声诊断和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 27949-2020 General requirements of disinfectant of medical instruments
    医疗器械消毒剂通用要求
    China National Standards
    medical

    English PDF
    GB/T 38800-2020 General technical requirements of modular isolation units for emergency medical ues
    应急医用模块化隔离单元通用技术要求
    China National Standards
    medical

    English PDF
    GB 9706.245-2020 medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
    医用电气设备 第2-45部分:乳腺X射线摄影设备和乳腺摄影立体定位装置的基本安全和基本性能专用要求
    China National Standards
    medical

    English PDF
    GB 9706.244-2020 medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
    医用电气设备 第2-44部分:X射线计算机体层摄影设备的基本安全和基本性能专用要求
    China National Standards
    medical

    English PDF
    GB 9706.228-2020 medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    医用电气设备 第2-28部分:医用诊断X射线管组件的基本安全和基本性能专用要求
    China National Standards
    medical

    English PDF
    GB 9706.217-2020 medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
    医用电气设备 第2-17部分:自动控制式近距离治疗后装设备的基本安全和基本性能专用要求
    China National Standards
    medical

    English PDF
    GB 9706.211-2020 medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
    医用电气设备 第2-11部分:γ射束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 9706.201-2020 medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    医用电气设备 第2-1部分:能量为1MeV至50MeV电子加速器基本安全和基本性能专用要求
    China National Standards
    medical

    English PDF
    GB 9706.103-2020 medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment
    医用电气设备 第1-3部分:基本安全和基本性能的通用要求 并列标准:诊断X射线设备的辐射防护
    China National Standards
    medical

    English PDF
    GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
    体外诊断医疗器械 生物源性样品中量的测量 有证参考物质及支持文件内容的要求
    China National Standards
    medical

    English PDF
    GB/T 38336-2019 Industrial, scientific and medical robots—Electromagnetic compatibility—Emission methods of measurement and limits
    工业、科学和医疗机器人 电磁兼容 发射测试方法和限值
    China National Standards
    medical

    English PDF
    GB/T 38326-2019 Industrial,scientific and medical robots—Electromagnetic compatibility—Immunity tests
    工业、科学和医疗机器人 电磁兼容 抗扰度试验
    China National Standards
    medical

    English PDF
    GB/T 38336-2019 Industrial, scientific and medical robots—Electromagnetic compatibility—Emission methods of measurement and limits
    工业、科学和医疗机器人 电磁兼容 发射测试方法和限值
    China National Standards
    medical

    English PDF
    GB/T 38326-2019 Industrial,scientific and medical robots—Electromagnetic compatibility—Immunity tests
    Industrial,scientific and medical robots—Electromagnetic compatibility—Immunity tests
    China National Standards
    medical

    English PDF
    GB 4824-2019 Industrial,scientific and medical equipment—Radio-frequency disturbance characteristics—Limits and methods of measurement
    工业、科学和医疗设备 射频骚扰特性 限值和测量方法
    China National Standards
    medical

    English PDF
    GB 4793.4-2019 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    测量、控制和实验室用电气设备的安全要求 第4部分:用于处理医用材料的灭菌器和清洗消毒器的特殊要求
    China National Standards
    medical

    English PDF
    GB 18040-2019 Requirements of emergency medical service facilities and equipments for civil transport airport
    民用运输机场应急救护设施设备配备
    China National Standards
    medical

    English PDF
    GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    医疗器械生物学评价 第3部分:遗传毒性、致癌性和生殖毒性试验
    China National Standards
    medical

    English PDF
    GB/T 36988-2018 Guidance for good tissue practice of human origin for tissue engineered medical products
    组织工程用人源组织操作规范指南
    China National Standards
    medical

    English PDF
    GB/T 22576.1-2018 medical laboratories—Requirements for quality and competence—Part 1: General requirements
    医学实验室-质量和能力的要求-第1部分:通用要求
    China National Standards
    medical

    English PDF
    GB/T 37237-2018 Forensic medical assessment for male sexual dysfunction
    男性性功能障碍法医学鉴定
    China National Standards
    medical

    English PDF
    GB/T 51319-2018 medical process gas system engineering design standards
    医药工艺用气系统工程设计标准
    China National Standards
    medical

    English PDF
    GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
    医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求
    China National Standards
    medical

    English PDF
    GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition,validation and maintenance of a sterilization process
    医疗器械的灭菌 微生物学方法 第2部分:用于灭菌过程的定义、确认和维护的无菌试验
    China National Standards
    medical

    English PDF
    GB/T 34411-2017 Specification for audit of basic medical insurance benefits
    基本医疗保险待遇稽核业务规范
    China National Standards
    medical

    English PDF
    GB/T 34282.2-2017 Social insurance relation transfer—Part 2:Basic medical insurance for employees
    社会保险关系转移接续 第2部分:职工基本医疗保险
    China National Standards
    medical

    English PDF
    GB/T 19212.16-2017 Safety of transformers,reactors,power supply units and combinations thereof—Part 16: Particular requirements and tests for isolating transformers for the supply of medical locations
    变压器、电抗器、电源装置及其组合的安全 第16部分:医疗场所供电用隔离变压器的特殊要求和试验
    China National Standards
    medical

    English PDF
    GB/T 35594-2017 medical packaging paper
    医用包装纸
    China National Standards
    medical

    English PDF
    GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
    医疗器械生物学评价 第10部分:刺激与皮肤致敏试验
    China National Standards
    medical

    English PDF
    GB/T 16886.12-2017 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 16886.5-2017 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
    医疗器械生物学评价 第5部分:体外细胞毒性试验
    China National Standards
    medical

    English PDF
    GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices
    医疗器械生物学评价 第13部分:聚合物医疗器械降解产物的定性与定量
    China National Standards
    medical

    English PDF
    GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of 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 15213-2016 medical electron accelerators—Functional performance characteristics and test methods
    医用电子加速器 性能和试验方法
    China National Standards
    medical

    English PDF
    GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
    医疗保健产品灭菌 辐射 第1部分: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 9706.16-2015 medical electrical equipment—Part 2: Particular requirements for the safety of radiotherapy simulators
    医用电气设备 第2部分:放射治疗模拟机安全专用要求
    China National Standards
    medical

    English PDF
    GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac 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 16174.1-2015 Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    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/T 16886.6-2015 Biological evaluation of medical devices—Part 6: Tests for local effects 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 1962.1-2015 Conical fittings with a 6%(Luer) taper for syringes,needles and certain other medical equipment—Part 1: General requirement
    注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头 第1部分:通用要求
    China National Standards
    medical

    English PDF
    GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices
    制造医疗器械用不锈钢针管
    China National Standards
    medical

    English PDF
    GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
    医疗器械生物学评价 第7部分:环氧乙烷灭菌残留量
    China National Standards
    medical

    English PDF
    GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices
    医疗器械生物学评价 第20部分:医疗器械免疫毒理学试验原则和方法
    China National Standards
    medical

    English PDF
    GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
    医疗保健产品灭菌 环氧乙烷 第1部分:医疗器械灭菌过程的开发、确认和常规控制的要求
    China National Standards
    medical

    English PDF
    GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    医疗保健产品灭菌 湿热 第1部分: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 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products
    医疗器械的灭菌 微生物学方法 第1部分:产品上微生物总数的测定
    China National Standards
    medical

    English PDF
    GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
    最终灭菌医疗器械包装 第2部分:成形、密封和装配过程的确认的要求
    China National Standards
    medical

    English PDF
    GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—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/T 17006.11-2015 Evaluation and routine testing in medical imaging departments—Part 2-6: Constancy tests—Imaging performance of computed tomography X-ray equipment
    医用成像部门的评价及例行试验 第2-6部分:X射线计算机体层摄影设备成像性能稳定性试验
    China National Standards
    medical

    English PDF
    GB/T 31596.4-2015 Social insurance terminology—Part 4: medical insurance
    社会保险术语 第4部分:医疗保险
    China National Standards
    medical

    English PDF
    GB 16383-2014 Quality control for radiation sterilization of medical and hygienical products
    医疗卫生用品辐射灭菌消毒质量控制
    China National Standards
    medical

    English PDF
    GB 4824-2013 Industrial, scientific and medical equipment—Radio-frequency disturbance characteristics-Limits and methods of measurement
    工业、科学和医疗(ISM)射频设备 骚扰特性 限值和测量方法
    China National Standards
    medical

    English PDF
    GB 29923-2013 National Food Safety Standard GMP of Formula Food for medical Use
    食品安全国家标准 特殊医学用途配方食品企业良好生产规范
    China National Standards
    medical

    English PDF
    GB 29922-2013 National Food Safety Standard-General Principles for the Formula Foods for Special medical Purpose
    食品安全国家标准 特殊医学用途配方食品通则
    China National Standards
    medical

    English PDF
    GB/Z 30154-2013 medical laboratories―Guidance on laboratory implementation of GB/T 22576-2008
    医学实验室 GB/T 22576-2008 实验室实施指南
    China National Standards
    medical

    English PDF
    GB/T 19046-2013 medical electron accelerators―Acceptance and periodic tests
    医用电子加速器 验收试验和周期检验规程
    China National Standards
    medical

    English PDF
    GB/T 16886.16-2013 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 29791.5-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for selftesting
    体外诊断医疗器械 制造商提供的信息(标示) 第5部分:自测用体外诊断仪器
    China National Standards
    medical

    English PDF
    GB/T 29791.4-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for selftesting
    体外诊断医疗器械 制造商提供的信息(标示) 第4部分:自测用体外诊断试剂
    China National Standards
    medical

    English PDF
    GB/T 29791.3-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
    体外诊断医疗器械 制造商提供的信息(标示) 第3部分:专业用体外诊断仪器
    China National Standards
    medical

    English PDF
    GB/T 29791.2-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
    体外诊断医疗器械 制造商提供的信息(标示) 第2部分:专业用体外诊断试剂
    China National Standards
    medical

    English PDF
    GB/T 29791.1-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
    体外诊断医疗器械 制造商提供的信息(标示) 第1部分:术语、定义和通用要求
    China National Standards
    medical

    English PDF
    GB/T 17256-2012 medical and functional classification of cycling and archery for disabled athletes
    残疾人自行车和射箭运动员医学和功能分级
    China National Standards
    medical

    English PDF
    GB 50751-2012 Technical code for medical gases engineering
    医用气体工程技术规范
    China National Standards
    medical

    English PDF
    GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2: Animal welfare requirements
    医疗器械生物学评价 第2部分:动物福利要求
    China National Standards
    medical

    English PDF
    GB/T 16886.19-2011 Biological evaluation of medical devices - Part 19: Physico-chemical,morphological and topographical 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 16886.18-2011 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
    医疗器械生物学评价 第18部分:材料化学表征
    China National Standards
    medical

    English PDF
    GB/T 16886.11-2011 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 27949-2011 Hygienic requirements for medical items disinfection
    医疗器械消毒剂卫生要求
    China National Standards
    medical

    English PDF
    GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
    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/T 27409-2010 Application of proficiency testing in the medical laboratory
    医学实验室能力验证的应用
    China National Standards
    medical

    English PDF
    GB/T 26199-2010 medical packaging base paper
    医用包装原纸
    China National Standards
    medical

    English PDF
    GB 16348-2010 Radiological protection standards for the examinee in medical X-ray diagnosis
    医用X射线诊断受检者放射卫生防护标准
    China National Standards
    medical

    English PDF
    GB/T 18268.26-2010 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD) medical equipment
    测量、控制和实验室用的电设备 电磁兼容性要求 第26部分:特殊要求 体外诊断(IVD)医疗设备
    China National Standards
    medical

    English PDF
    GB 25596-2010 National Food Safety Standard-Generic rules for infant formula for special medical use
    食品安全国家标准 特殊医学用途婴儿配方食品通则
    China National Standards
    medical

    English PDF
    GB 19083-2010E Technical requirements for protective face mask for medical use
    医用防护口罩技术要求(英文版)
    China National Standards
    medical

    English PDF
    GB 19083-2010 Technical requirements for protective face mask for medical use
    医用防护口罩技术要求
    China National Standards
    medical

    English PDF
    GB 24788-2009 Limit for the removable surface powder and water-extractable protein of medical gloves
    医用手套表面残余粉末、水抽提蛋白质限量
    China National Standards
    medical

    English PDF
    GB 24786-2009 Single-use medical poly (vinyl chloride) examination gloves
    一次性使用聚氯乙烯医用检查手套
    China National Standards
    medical

    English PDF
    GB/T 24791.3-2009 Photography - Sensitometry of screen/film systems for medical radiography - Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography
    摄影 医疗X射线成像用屏/片系统的感光测定 第3部分:乳腺X射线成像感光特性曲线形状、感光度与平均斜率的测定
    China National Standards
    medical

    English PDF
    GB/T 24791.1-2009 Photography - Sensitometry of screen/film systems for medical X-radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
    摄影 医疗X射线成像用屏/片系统的感光测定 第1部分:感光特性曲线形状、感光度与平均斜率的测定
    China National Standards
    medical

    English PDF
    GB 9706.17-2009 medical electrical equipment - Part 2: Particular requirements for the safety of gamma beam therapy equipment
    医用电气设备 第2部分:γ射束治疗设备安全专用要求
    China National Standards
    medical

    English PDF
    GB 24627-2009 Standard specification for wrought nickel-titanium shape memory alloys for medical devices and surgical implants
    医疗器械和外科植入物用镍-钛形状记忆合金加工材
    China National Standards
    medical

    English PDF
    GB/T 14710-2009 The environmental requirement and test methods for medical electrical equipment
    医用电器环境要求及试验方法
    China National Standards
    medical

    English PDF
    GB 10010-2009 Plasticized polyvinyl chloride(PVC) tubing for medical uses
    医用软聚氯乙烯管材
    China National Standards
    medical

    English PDF
    GB/T 13797-2009 General specifications for medical X-ray tube
    医用X射线管通用技术条件
    China National Standards
    medical

    English PDF
    GB/T 16433-2009 medical and functional classification of athletics for disabled athletes
    残疾人田径运动员医学和功能分级
    China National Standards
    medical

    English PDF
    GB 19082-2009E Technical Requirements for Single-use Protective Clothing for medical Use
    医用一次性防护服技术要求(英文版)
    China National Standards
    medical

    English PDF
    GB 9706.8-2009 medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
    医用电气设备 第2-4部分:心脏除颤器安全专用要求
    China National Standards
    medical

    English PDF
    GB 9706.4-2009 medical electrical equipment - Part 2-2: Particular requirements for the safety 0f high frequency surgical equipment
    医用电气设备 第2-2部分:高频手术设备安全专用要求
    China National Standards
    medical

    English PDF
    GB 19082-2009 Technical requirements for single-use protective clothing for medical use
    医用一次性防护服技术要求
    China National Standards
    medical

    English PDF
    GB/T 15722-2009 Competitive qualification of medical stardard of volleyballsitting for disabled athletes
    残疾人坐地排球运动员参赛资格的医学标准
    China National Standards
    medical

    English PDF
    GB/T 14726-2009 medical and functional classification for disabled athletes
    残疾运动员的医学和功能分级
    China National Standards
    medical

    English PDF
    GB 9706.39-2008 medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
    医用电气设备 第2-39部分:腹膜透析设备的安全专用要求
    China National Standards
    medical

    English PDF
    GB 11243-2008 medical electrical equipment - Part 2: Particular requirements for safety of baby incubators
    医用电气设备 第2部分:婴儿培养箱安全专用要求
    China National Standards
    medical

    English PDF
    GB/T 22576-2008 medical laboratories - Particular requirements for quality and competence
    医学实验室 质量和能力的专用要求
    China National Standards
    medical

    English PDF
    GB 9706.5-2008 medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
    医用电气设备 第2部分:能量为1MeV至50 MeV电子加速器安全专用要求
    China National Standards
    medical

    English PDF

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