Cart:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| GB 19083-2023 |
medical protective mask {译} 医用防护口罩 |
China National Standards medical |
 English PDF |
| GB 19082-2023 |
medical disposable protective clothing {译} 医用一次性防护服 |
China National Standards medical |
English PDF |
| GB/Z 43280-2023 |
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 medical |
English PDF |
| GB/T 16886.23-2023 |
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 medical |
English PDF |
| GB/T 16886.12-2023 |
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 medical |
English PDF |
| GB/T 43312-2023 |
Wire rope for medical equipment {译} 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 {译} 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 {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 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 {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 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 {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 |
China National Standards medical |
English PDF |
| GB 29923-2023 |
National Food Safety Standard Good Manufacturing Practice for Formulas for Special medical Purposes {译} 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 {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 |
China National Standards medical |
English PDF |
| GB/T 13797-2023 |
General technical requirements for medical X-ray tubes {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 {译} 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 |
| 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 |
| GB 9706.15-2008 |
medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems 医用电气设备 第1-1部分：通用安全要求 并列标准：医用电气系统安全要求 |
China National Standards medical |
English PDF |
| GB 9706.13-2008 |
medical electrical equipment - Part 2: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment 医用电气设备 第2部分：自动控制式近距离治疗后装设备安全专用要求 |
China National Standards medical |
English PDF |
| GB/T 14233.1-2008 |
Test methods for infusion, transfusion, injection equipments for medical use - 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 10151-2008 |
medical diagnostic X-ray equipment - Specifications for high voltage cable plugs and sockets 医用诊断X射线设备高压电缆插头、插座技术条件 |
China National Standards medical |
English PDF |
| GB/T 18773-2008 |
Environmental sanitation standard for incineration of medical treatment wastes 医疗废物焚烧环境卫生标准 |
China National Standards medical |
English PDF |
| GB/T 21870-2008 |
medical gloves made from natural rubber latex - Determination of water-extractable protein using the modified Lowry method 天然胶乳医用手套水抽提蛋白质的测定 改进Lowry法 |
China National Standards medical |
English PDF |
| GB/T 21869-2008 |
medical gloves - Determination of removable surface powder 医用手套表面残余粉末的测定 |
China National Standards medical |
English PDF |
| GB 18040-2008 |
Requirement of airports facilities for emergency medical services 民用运输机场应急救护设施配备 |
China National Standards medical |
English PDF |
| GB/T 16846-2008 |
Requirement for the declaration of the acoustic output of medical diagnostic ultrasonic equipment 医用超声诊断设备声输出公布要求 |
China National Standards medical |
English PDF |
| GB 9706.9-2008 |
medical electrical equipment - Part 2-37: Particular requirements for the safety 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安全专用要求 |
China National Standards medical |
English PDF |
| GB 9706.7-2008 |
medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment 医用电气设备 第2-5部分：超声理疗设备安全专用要求 |
China National Standards medical |
English PDF |
| GB 4793.8-2008 |
Safety requirements for electrical equipment for measurement,control,and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials,and for laboratory processes 测量、控制和试验室用电气设备的安全要求 第2-042部分：使用有毒气体处理医用材料及供试验室用的压力灭菌器和灭菌器的专用要求 |
China National Standards medical |
English PDF |
| GB/T 21415-2008 |
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials 体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性 |
China National Standards medical |
English PDF |
| GB/T 16886.3-2008 |
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 16175-2008 |
Biological evaluation test methods for medical organic silicon materials 医用有机硅材料生物学评价试验方法 |
China National Standards medical |
English PDF |
| GB/T 15566.6-2007 |
Guidance system for public information - Setting principles and requirements - Part 6: medical site 公共信息导向系统 设置原则与要求 第6部分: 医疗场所 |
China National Standards medical |
English PDF |
| GB 9706.6-2007 |
medical electrical equipment - Part 2：Particular requirements for the safety of microwave therapy equipment 医用电气设备 第二部分：微波治疗设备安全专用要求 |
China National Standards medical |
English PDF |
| GB 9706.1-2007 |
medical electrical equipment - Part 1:General requirements for safety 医用电气设备 第1部分：安全通用要求 |
China National Standards medical |
English PDF |
| GB/T 19042.5-2006 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests-Imaging performances of computed tomography X-ray equipment 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 |
China National Standards medical |
English PDF |
| GB 9706.18-2006 |
medical electrical equipment - Part 2: Particular requirements for the safety of X-ray equipment for computed tomography 医用电气设备 第2部分：X射线计算机体层摄影设备安全专用要求 |
China National Standards medical |
English PDF |
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