China Medical devices--Val GB Standards Search Result |
 |
1. Ready translated GB standards
and Chinese version GB Standards, you can purchase directly
in the web page; After receive your payment, we will send
the GB Standards PDF file to your Email within 1~3 days.
2. Other English version GB Standards are not ready translated, only after get your order, then we translate them, time usually need 3-5 days . |
|
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 - 中英文版 |
 |
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
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 - 中英文版 |
|
|
|
|
GB/T 17006.5-2000 Evaluation and routine testing in medical imaging departments--Part 2-5:Constancytests--Image display devices 医用成像部门的评价及例行试验 第2-5部分:图像显示装置稳定性试验 - 中英文版 |
|
| Find out:51Items | To Page of: First -Previous-Next -Last | 1 2 |
+86-755-2583-1330
