标准号: |
ISO 11607-1-2006 |
英文名称: |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
中标分类: |
医药卫生劳动保护>>医疗器械综合 |
发布日期: |
2006-04 |
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 |
正文语言: |
英语 |
页数: |
24P;A4 |
附注: |
/ Note: To be amended by ISO 11607-1 DAM 1 (2013-03), ISO 11607-1 FDAM 1 (2014-03). |
被代替标准: |
ISO 11607-2003;ISO/FDIS 11607-1-2006 |
引用标准: |
ISO 5636-5-2003 |
采用关系: |
DIN EN ISO 11607-1-2006,IDT;DIN EN ISO 11607-1-2009,IDT;DIN EN ISO 11607-1-2014,IDT;DIN EN ISO 11607-1/A1-2009,IDT;ANSI/AAMI/ISO 11607-1-2006,IDT;ABNT NBR ISO 11607-1-2013,IDT;BS EN ISO 11607-1-2006,IDT;BS EN ISO 11607-1+A1-2010,IDT;GB/T 19633.1-2015,IDT;EN ISO 11607-1-2006,IDT;EN ISO 11607-1-2009,IDT;prEN ISO 11607-1-2009,IDT;NF S98-052-1-2006,IDT;NF S98-052-1-2009,IDT;NF S98-052-1,IDT;S98-052-1PR,IDT;JIS T 0841-1-2009,IDT;CAN/CSA-ISO 11607-1-2016,IDT;SN EN ISO 11607-1-2006,IDT;SN EN ISO 11607-1-2009,IDT;OENORM EN ISO 11607-1-2006,IDT;OENORM EN ISO 11607-1-2007,IDT;OENORM EN ISO 11607-1-2009,IDT;OENORM EN ISO 11607-1-2014,IDT;OENORM EN ISO 11607-1-2009,IDT;PN-EN ISO 11607-1-2006,IDT;PN-EN ISO 11607-1-2007,IDT;PN-EN ISO 11607-1-2009,IDT;PN-EN ISO 11607-1-2011,IDT;SS-EN ISO 11607-1-2006,IDT;SS-EN ISO 11607-1-2009,IDT;UNE-EN ISO 11607-1-2006,IDT;UNE-EN ISO 11607-1-2007,IDT;UNE-EN ISO 11607-1-2009,IDT;SANS 11607-1-2007,IDT;KS P ISO 11607-1-2007,IDT;GOST R ISO 16061-2011,IDT;TS EN ISO 11607-1-2010,IDT;DS/EN ISO 11607-1-2006,IDT;DS/EN ISO 11607-1-2009,IDT;UNI EN ISO 11607-1-2006-2006,IDT;UNI EN ISO 11607-1-2009-2009,IDT;UNI EN ISO 11607-1-2014-2014,IDT;STN EN ISO 11607-1-2006,IDT;STN EN ISO 11607-1-2007,IDT;STN EN ISO 11607-1-2009,IDT;SANS 11607-1-2007,IDT;SANS 11607-1-2007-2007,IDT;CSN EN ISO 11607-1-2006,IDT;CSN EN ISO 11607-1-2010,IDT;DS/EN ISO 11607-1-2006,IDT;DS/EN ISO 11607-1-2009,IDT;NEN-EN-ISO 11607-1-2006 en-2006,IDT;NEN-EN-ISO 11607-1-2009 en-2009,IDT;SANS 11607-1-2007-2007,IDT |
内容提要(CN): |
闭塞物;定义;可处置的;一般条件;卫生学;检验;材料规范;医疗设备;医疗产品;医学科学;医疗技术学;包装件;包装材料;包装试验;物理试验;产品;公共卫生;质量;质量保证;质量管理;规格试验;重新使用;安全;安全要求;抽样方法;规范;规范(验收);稳定性;消毒阻挡系统;无菌;灭菌;消毒物品;灭菌器;储存;试验;应用;证实;外观检查(试验) |
内容提要(EN): |
Applications;Biocompatibility;Biological hazards;Closures;Compatibility;Conditioning;Covers;Definitions;Density;Disposables;General conditions;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);Sterilized goods;Sterilizers;Storage;Systems;Testing;Toxicity;Transport;Use;Validation;Visual inspection (testing) |
归属: |
国际 |
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