标准号: |
ISO/TS 16775-2014 |
英文名称: |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
中标分类: |
医药卫生劳动保护>>医疗器械综合 |
发布日期: |
2014-05 |
发布单位: |
IX-ISO |
标准状态: |
请与本站工作人员进行确认 |
ICS分类: |
封装消毒>>封装消毒 |
起草单位/标准公告: |
ISO/TC 198 Sterilisation von Produkten fur die Gesundheitsvorsorge;ISO/TC 198 Sterilization of health care products;ISO/TC 198 Stérilisation des produits de santé |
正文语言: |
英语 |
页数: |
115P.;A4 |
引用标准: |
DIN 58921-2011;DIN 58953-6-2010;DIN 58953-7-2010;DIN 58953-8-2010;ANSI/AAMI ST 58-2013;ANSI/AAMI ST 63-2002;ANSI/ASQ Z 1.4-2003;ANSI/ASQ Z 1.9-2003;ASTM D 589-1997;ASTM D 882-2012;ASTM D 1003-2013;ASTM D 1709-2009;ASTM D 1894-2014;ASTM D 1922-2009;ASTM D 1938-2008;ASTM D 2457-2013;ASTM D 3078-2002;ASTM D 3420-2008;ASTM D 3776-2009;ASTM D 3985-2005;ASTM D 4169-2009;ASTM D 4321-2009;ASTM D 4754-2011;ASTM D 5264-1998;ASTM F 17-2013;ASTM F 88-2007;ASTM F 372-1999;ASTM F 392-1993;ASTM F 904-1998;ASTM F 1140-2007;ASTM F 1249-2013;ASTM F 1306-1990;ASTM F 1327-2005;ASTM F 1886-1998;ASTM F 1929-2012;ASTM F 1980-2007;ASTM F 2029-2008;ASTM F 2054-2007;ASTM F 2096-2011 |
采用关系: |
DIN CEN ISO/TS 16775-2014,IDT;PD CEN ISO/TS 16775-2014,IDT;CEN ISO/TS 16775-2014,IDT;ONR CEN ISO/TS 16775-2014,IDT;DS/CEN ISO/TS 16775-2014,IDT;UNI CEN ISO/TS 16775-2014-2014,IDT;STN P CEN ISO/TS 16775-2014,IDT;CSN P CEN ISO/TS 16775-2014,IDT;DS/CEN ISO/TS 16775-2014,IDT;NPR-CEN-ISO/TS 16775-2014 en-2014,IDT |
内容提要(EN): |
Applications;Biocompatibility;Biological hazards;Closures;Compatibility;Conditioning;Covers;Definitions;Density;Disposables;Germs;Hygiene;Information;Inspection;Marking;Materials specification;Medical devices;Medical equipment;Medical products;Medical sciences;Medical technology;Methods;Packages;Packaging material;Packaging tests;Permability;Physical testing;Products;Public health;Quality;Quality assurance;Quality management;Rating tests;Reagents;Reuse;Safety;Safety requirements;Sampling methods;Sequence of operations;Specification;Specification (approval);Stability;Sterile barrier systems;Sterility;Sterilization (birth control);Sterilization (hygiene);Ster |
归属: |
国际 |