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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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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 - 中英文版 |
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GB/T 16886.17-2005 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances 医疗器械生物学评价 第17部分：可沥滤物允许限量的建立 - 中英文版 |
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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 - 中英文版 |
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GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity 医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验 - 中英文版 |
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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 - 中英文版 |
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GB/T 19633-2005 Packaging for terminally sterilized medical devices 最终灭菌医疗器械的包装 - 中英文版 |
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GB/T 16886.5-2003 Biological evaluation ofmedical devices--Part 5: Test 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 - 中英文版 |
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GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4:Selection of tests for interactions 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 - 中英文版 |
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GB/T 16886.9-2001 Biological evaluation of medical devices--Part 9:Framework for identification and quantification of potential degradation product 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 - 中英文版 |
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GB 18457-2001 Stainless steel needle tubing for manufactureof medical devices 制造医疗器械用不锈钢针管 - 中英文版 |
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GB/T 16886.6-1997 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 - 中英文版 |
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