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 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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