China Medical Device GB Standards English PDF List

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China "Medical Device" GB Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	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 Device	English PDF
GB/T 19973.1-2005	Sterilization of Medical Devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products 医用器材的灭菌微生物学方法第一部分:产品上微生物总数的估计	China National Standards Medical Device	English PDF
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	China National Standards Medical Device	English PDF
GB/T 19703-2005	In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-Description of reference materials 体外诊断医疗器械生物源性样品中量的测量参考物质的说明	China National Standards Medical Device	English PDF
GB/T 19702-2005	In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-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说明	China National Standards Medical Device	English PDF
GB/T 16886.12-2005	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:样品制备与参照样品	China National Standards Medical Device	English PDF
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	China National Standards Medical Device	English PDF
GB/T 19633-2005	Packaging for terminally sterilized Medical Devices 最终灭菌医疗器械的包装	China National Standards Medical Device	English PDF
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	China National Standards Medical Device	English PDF
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	China National Standards Medical Device	English PDF
GB/T 16886.15-2003	Biological evaluation of Medical Devices--Part 15:Identification and quantification of degradation products from 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 Device	English PDF
GB/T 16886.14-2003	Biological evaluation of Medical Devices--Part 14:Identification and quantification of degradation products from ceramics 医疗器械生物学评价第14部分:陶瓷降解产物的定性与定量	China National Standards Medical Device	English PDF
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	China National Standards Medical Device	English PDF
GB/T 16886.7-2001	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 Device	English PDF
GB/T 16886.13-2001	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:聚合物医疗器械的降解产物的定性与定量	China National Standards Medical Device	English PDF
GB 18457-2001	Stainless steel needle tubing for manufactureof Medical Devices 制造医疗器械用不锈钢针管	China National Standards Medical Device	English PDF
GB 18279-2000	Medical Devices--Validation androutine control of ethylene oxide sterilization 医疗器械环氧乙烷灭菌确认和常规控制	China National Standards Medical Device	English PDF
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	China National Standards Medical Device	English PDF

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