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| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| 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 devices the |
 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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
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 devices the |
English PDF |
| GB/T 19974-2005 |
Sterilization of health care products -- General requirement for characterization of a sterilizing 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工艺的设定、确认和常规控制的通用要求 |
China National Standards Medical devices the |
English PDF |
| GB/T 19973.2-2005 |
Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process 医用器材的灭菌 微生物学方法 第二部分：确认灭菌过程的无菌试验 |
China National Standards Medical devices the |
English PDF |
| GB 19212.16-2005 |
Safety of power transformers ,power supply units and similar devices -- Part 16: Particular requirements for isolating transformers for the supply of medical locations 电力变压器、电源装置和类似产品的安全 第16部分：医疗场所供电用隔离变压器的特殊要求 |
China National Standards Medical devices the |
English PDF |
| GB 9706.24-2005 |
Medical electrical equipment-Part2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices 医用电气设备 第2-45部分:乳腺X射线摄影设备及乳腺摄影立体定位装置 安全专用要求 |
China National Standards Medical devices the |
English PDF |
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