China Sterile medical device Industry Standards English PDF List

China "Sterile medical device" Industry Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
YY/T 0033-2000	Standards for Production Management of Sterile medical devices {译} 无菌医疗器具生产管理规范	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.12-2022	Test methods for Sterile medical device packaging - Part 12: Soft barrier materials rub resistance {译} 无菌医疗器械包装试验方法第12部分：软性屏障材料抗揉搓性	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.4—2021	Test methods for Sterile medical device packaging - Part 4: Determination of seal leakage of breathable packaging by dye penetration method {译} 无菌医疗器械包装试验方法第4部分：染色液穿透法测定透气包装的密封泄漏	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.18-2020	Test methods for packaging of Sterile medical devices - Part 18: Non-destructive testing of packaging for leaks by the vacuum decay method {译} 无菌医疗器械包装试验方法第18部分：用真空衰减法无损检验包装泄漏	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.16—2019	Test methods for packaging of Sterile medical devices - Part 16: Test for climatic resilience of packaging systems {译} 无菌医疗器械包装试验方法第16部分:包装系统气候应变能力试验	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.17-2019	Test methods for packaging of Sterile medical devices - Part 17: Microbial barrier testing by aerosol filtration for breathable packaging materials {译} 无菌医疗器械包装试验方法第17部分：透气包装材料气溶胶过滤法微生物屏障试验	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.15-2019	Sterile medical device packaging test methods - Part 15: Performance testing of shipping containers and systems {译} 无菌医疗器械包装试验方法第15部分：运输容器和系统的性能试验	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.13-2014	Test methods for Sterile medical device package. Part 13: Slow rate penetration resistance of flexible barrier films and laminates 无菌医疗器械包装试验方法第13部分:软性屏障膜和复合膜抗慢速戳穿性	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.12-2014	Test methods for Sterile medical device package. Part 12: Flex durability of flexible barrier films 无菌医疗器械包装试验方法第12部分:软性屏障膜抗揉搓性	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.11-2014	Test methods for Sterile medical device package. Part 11: Determining integrity of seals for medical packaging by visual inspection 无菌医疗器械包装试验方法第11部分:目力检测医用包装密封完整性	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.13-2014	Test methods for packaging of Sterile medical devices - Part 13: Slow puncture resistance of soft barrier films and composite films{译} {译} 无菌医疗器械包装试验方法第13部分：软性屏障膜和复合膜抗慢速戳穿性	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.12-2014	Test methods for packaging of Sterile medical devices - Part 12: Scrub resistance of soft barrier films{译} {译} 无菌医疗器械包装试验方法第12部分：软性屏障膜抗揉搓性	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.11-2014	Sterile medical device packaging test methods - Part 11: Visual inspection of medical packaging seal integrity{译} {译} 无菌医疗器械包装试验方法第11部分：目力检测医用包装密封完整性	China Pharmaceutics Industry Standards Sterile medical device	English PDF
YY/T 0681.9-2011	Test methods for Sterile medical device package. Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates 无菌医疗器械包装试验方法第9部分：约束板内部气压法软包装密封胀破试验	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.8-2011	Test methods for Sterile medical device package. Part 8: Coating/adhesive weight determination 无菌医疗器械包装试验方法第8部分：涂胶层重量的测定	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.7-2011	Test methods for Sterile medical device package. Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape 无菌医疗器械包装试验方法第7部分：用胶带评价软包装材料上印墨或涂层附着性	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.6-2011	Test methods for Sterile medical device package. Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials 无菌医疗器械包装试验方法第6部分：软包装材料上印墨和涂层抗化学性评价	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.10-2011	Test methods for Sterile medical device package. Part 10: Test for microbial barrier ranking of porous package material 无菌医疗器械包装试验方法第10部分：透气包装材料微生物屏障分等试验	China Medicine & Medical Device Standards Sterile medical device	English PDF
SN/T 3062.4-2011	Packaging materials for terminally sterilized medical devices for import. Part 4: Requirements for materials and sterile barrier systems of importing medical device sterilization packaging 进口医疗器械灭菌包装第4部分：材料和预成型无菌屏障系统要求	China Import Export Inspection Standards Sterile medical device	English PDF
YY/T 0681.5-2010	Test methods for Sterile medical device package. Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test) 无菌医疗器械包装试验方法第5部分：内压法检测粗大泄漏（气泡法）	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.4-2010	Test methods for Sterile medical device package. Part 4: Detecting seal leaks in porous packages by dye penetration 无菌医疗器械包装试验方法第4部分：染色液穿透法测定透气包装的密封泄漏	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.3-2010	Test methods for Sterile medical device package. Part 3: Internal pressurization failure resistance of unrestrained packages 无菌医疗器械包装试验方法第3部分：无约束包装抗内压破坏	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.2-2010	Test methods for Sterile medical device package. Part 2: Seal strength of flexible battier materials 无菌医疗器械包装试验方法第2部分：软性屏障材料的密封强度	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0698.6-2009	Packaging materials for terminal sterilized medical devices. Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation. Requirements and test methods 最终灭菌医疗器械包装材料第6部分：用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸要求和试验方法	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0681.1-2009	Test methods for Sterile medical device package. Part 1: Test guide for accelerated aging 无菌医疗器械包装试验方法第1部分：加速老化试验指南	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0615.2-2007	Requirements for medical devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices 标示“无菌”医疗器械的要求第2部分:无菌加工医疗器械的要求	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY/T 0615.1-2007	Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices 标示无菌医疗器械的要求第1部分:最终灭菌医疗器械的要求	China Medicine & Medical Device Standards Sterile medical device	English PDF
YY 0033-2000	Good manufacture practice for Sterile medical devices 无菌医疗器具生产管理规范	China Medicine & Medical Device Standards Sterile medical device	English PDF

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