China Sterile Industry Standards English PDF List

China "Sterile" Industry Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
YY/T 0489—2023	Disposable Sterile drainage catheters and auxiliary devices {译} 一次性使用无菌引流导管及辅助器械	China Pharmaceutics Industry Standards Sterile	English PDF
YY/T 1906-2023	Disposable Sterile closure clips {译} 一次性使用无菌闭合夹	China Pharmaceutics Industry Standards Sterile	English PDF
YY 0852—2023	Disposable Sterile surgical membrane {译} 一次性使用无菌手术膜	China Pharmaceutics Industry Standards Sterile	English PDF
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	English PDF
YY/T 1866-2023	Disposable Sterile anorectal ligation rubber ring or elastic thread type {译} 一次性使用无菌肛肠套扎器胶圈或弹力线式	China Pharmaceutics Industry Standards Sterile	English PDF
YY/T 0325-2022	Disposable Sterile urinary catheter {译} 一次性使用无菌导尿管	China Pharmaceutics Industry Standards Sterile	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	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	English PDF
YY/T 0567.2—2021	Aseptic Processing of Healthcare Products Part 2: Sterile Filtration {译} 医疗保健产品的无菌加工第2部分：除菌过滤	China Pharmaceutics Industry Standards Sterile	English PDF
YY 0450.1-2020	Accessory devices for Sterile single-use intravascular catheters--Part 1:Introducers 一次性使用无菌血管内导管辅件第1部分：导引器械	China YY-Medicine & Medical Device Industry Standards Sterile	English PDF
YY 0852-2011/XG1-2020	Sterile surgical films for single use 《一次性使用无菌手术膜》行业标准第1号修改单	China YY-Medicine & Medical Device Industry Standards Sterile	English PDF
YY/T 0285.6-2020	Intravascular catheters - Sterile single-use catheters - Part 6: Subcutaneous implantable drug delivery devices {译} 血管内导管一次性使用无菌导管第6部分：皮下植入式给药装置	China Pharmaceutics Industry Standards Sterile	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	English PDF
YY 0336—2020	Disposable Sterile vaginal dilators {译} 一次性使用无菌阴道扩张器	China Pharmaceutics Industry Standards Sterile	English PDF
YY/T 0573.4—2020	Single-use Sterile syringes Part 4: Preventing re-use of syringes {译} 一次性使用无菌注射器第4部分：防止重复使用注射器	China Pharmaceutics Industry Standards Sterile	English PDF
YY 0450.1—2020	Disposable Sterile endovascular catheter accessories Part 1: Guiding instruments {译} 一次性使用无菌血管内导管辅件第1部分：导引器械	China Pharmaceutics Industry Standards Sterile	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	English PDF
YY/T 0573.3—2019	Single-use Sterile syringes Part 3: Self-destructing fixed-dose vaccine syringes {译} 一次性使用无菌注射器第3部分：自毁型固定剂量疫苗注射器	China Pharmaceutics Industry Standards Sterile	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	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	English PDF
HG/T 5109-2016	(Sterile double tube plate shell and tube heat exchanger) 无菌级双管板管壳式换热器	China Chemical Industry Standards Sterile	English PDF
YY 0325-2016	Sterile urethral catheter for single use 一次性使用无菌导尿管	China Medicine & Medical Device Standards Sterile	English PDF
SN/T 4391-2015	(Determination of disposable hygiene products sanitary napkins, sanitary pads, diapers, Sterile cotton ethylene oxide residues) 一次性卫生用品卫生巾、卫生护垫、纸尿裤、消毒棉环氧乙烷残留量的测定	China Import Export Inspection Standards Sterile	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	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	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	English PDF
YY/T 0929.1-2014	Sterile-grade filters for infusions - Part 1: Integrity test of filters for liquid medicines{译} {译} 输液用除菌级过滤器第1部分：药液过滤器完整性试验	China Pharmaceutics Industry Standards Sterile	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	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	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	English PDF
YY 0336-2013	Sterile vaginal dilator for single use 一次性使用无菌阴道扩张器	China Medicine & Medical Device Standards Sterile	English PDF
YY 0852-2011	Sterile surgical films for single use 一次性使用无菌手术膜	China YY-Medicine & Medical Device Industry Standards Sterile	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	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	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	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	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	English PDF
YY 0852-2011	Sterile surgical films for single use 一次性使用无菌手术膜	China Medicine & Medical Device Standards Sterile	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	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	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	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	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	English PDF
YY/T 0487-2010	Sterile, single-use hydrocephalus shunts and components 一次性使用无菌脑积水分流器及其附件	China Medicine & Medical Device Standards Sterile	English PDF
YY 0573.4-2010	Sterile hypodermic syringes for single use. Part 4: Syringes with re-use prevention feature 一次性使用无菌注射器第4部分：防止重复使用注射器	China Medicine & Medical Device Standards Sterile	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	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	English PDF
SN/T 0323.2-2007	Rules for the inspection of medical equipment for import and export. Part 2: Sterile hypodermic syringes for single use 进出口医疗器械检验规程第2部分:一次性使用无菌注射器	China Import Export Inspection Standards Sterile	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	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	English PDF
YY 0587-2005	Sterile dental injection needles for single use 一次性使用无菌牙科注射针	China Medicine & Medical Device Standards Sterile	English PDF
YY 0497-2005	Sterile insulin syringe for single use 一次性使用无菌胰岛素注射器	China Medicine & Medical Device Standards Sterile	English PDF
YY 0573.3-2005	Sterile hypodermic syringes for single use. Part 3: Auto-disable syringes for fixed dose immunization 一次性使用无菌注射器第3部分：自毁型固定剂量疫苗注射器	China Medicine & Medical Device Standards Sterile	English PDF
YY/T 0507.2-2005	(Medical Products - Sterile Processing - Part 2: Filter)	China Medicine & Medical Device Standards Sterile	English PDF
YY/T 0507.1-2005	(Medical Products - Sterile Processing - Part 1: General requirements)	China Medicine & Medical Device Standards Sterile	English PDF
YY 0489-2004	Sterile drainage catheters and accessory devices for single use 一次性使用无菌引流导管及辅助器械	China Medicine & Medical Device Standards Sterile	English PDF
YY 0285.5-2004	Sterile, single-use intravascular catheters. Part 5: Over-needle peripheral catheters 一次性使用无菌血管内导管第5部分：套针外周导管	China Medicine & Medical Device Standards Sterile	English PDF
YY 0285.1-2004	Sterile, single-use intravascular catheters. Part 1: General requirements 一次性使用无菌血管内导管第1部分：通用要求	China Medicine & Medical Device Standards Sterile	English PDF
YY 0488-2004	Sterile rectal catheters for single use 一次性使用无菌直肠导管	China Medicine & Medical Device Standards Sterile	English PDF
YY 0450.1-2003	Accessory devices for Sterile single-use intravascular catheters. Part 1: Introducers 一次性使用无菌血管内导管辅件第1部分：导引器械	China Medicine & Medical Device Standards Sterile	English PDF
YY 0450.2-2003	Accessory devices for Sterile single-use intravascular catheters. Part 2: Obturators for over-needle peripheral catheters 一次性使用无菌血管内导管辅件第2部分：套针外周导管管塞	China Medicine & Medical Device Standards Sterile	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	English PDF
YY 0285.4-1999	Sterile, single-use intravascular catheters. Part 4: Balloon dilatation catheters 一次性使用无菌血管内导管第4部分: 球囊扩张导管	China Medicine & Medical Device Standards Sterile	English PDF
YY 0285.3-1999	Sterile, single-use intravasoular catheters. Part 3: Central venous catheters 一次性使用无菌血管内导管第3部分:中心静脉导管	China Medicine & Medical Device Standards Sterile	English PDF
YY 0285.2-1999	Sterile, single-use intravascular catheters. Part 2: Angiographic catheters 一次性使用无菌血管内导管第2部分:造影导管	China Medicine & Medical Device Standards Sterile	English PDF

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