标准号: |
ISO 11607-2 AMD 1-2014 |
英文名称: |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes; Amendment 1 |
中标分类: |
医药卫生劳动保护>>医疗器械综合 |
发布日期: |
2014-07 |
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: |
2P.;A4 |
被代替标准: |
ISO 11607-2 FDAM 1-2014 |
采用关系: |
DIN EN ISO 11607-2-2014,IDT;ANSI/AAMI/ISO 11607-2 AMD 1-2014,IDT;EN ISO 11607-2/A1-2014,IDT;NF S98-052-2/A1-2014,IDT;SN EN ISO 11607-2/A1-2014,IDT;OENORM EN ISO 11607-2-2014,IDT;PN-EN ISO 11607-2/A1-2014,IDT;PN-EN ISO 11607-2/A1-2015,IDT;SS-EN ISO 11607-2/A1-2014,IDT;UNE-EN ISO 11607-2/A1-2014,IDT;TS EN ISO 11607-2/A1-2015,IDT;DS/EN ISO 11607-2/A1-2014,IDT;CSN EN ISO 11607-2-2006,IDT;DS/EN ISO 11607-2/A1-2014,IDT;NEN-EN-ISO 11607-2-2006/A1-2014 en-2014,IDT |
内容提要(EN): |
Design;Disposables;Forming;Marking;Materials specification;Medical devices;Medical products;Packages;Packaging material;Performance;Physical testing;Public health;Qualifications;Quality;Quality assurance;Reuse;Sampling methods;Sealing;Shaping;Specification;Specification (approval);Sterile barrier systems;Sterility;Testing;Validation;Visual inspection (testing) |
归属: |
国际 |
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