标准号: |
ISO 11135-2014 |
英文名称: |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
中标分类: |
医药卫生劳动保护>>理疗与中医仪器设备 |
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: |
消毒和灭菌综合>>消毒和灭菌综合 |
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: |
78P.;A4 |
被代替标准: |
ISO/FDIS 11135-2014;ISO 11135-1-2007;ISO/TS 11135-2-2008;ISO/TS 11135-2 Technical Corrigendum 1-2009 |
引用标准: |
ANSI/AAMI ST 41-1999;EN 556-1-2001;IEC 61010-1-2010;IEC 61010-2-040-2005;ISO/IEC Guide 99-2007;ISO 9000-2005;ISO 9001-2008;ISO 10012-2003;ISO 10993-1-2009;ISO 10993-1 Technical Corrigendum 1-2010;ISO 10993-2-2006;ISO 10993-3-2003;ISO 10993-4-2002;ISO 10993-4 AMD 1-2006;ISO 10993-5-2009;ISO 10993-6-2007;ISO 10993-7-2008;ISO 10993-7 Technical Corrigendum 1-2009;ISO 10993-9-2009;ISO 10993-10-2010;ISO 10993-11-2006;ISO 10993-12-2012;ISO 10993-13-2010;ISO 10993-14-2001;ISO 10993-15-2000;ISO 10993-16-2010;ISO 10993-17-2002;ISO 10993-18-2005;ISO 11138-1-2006;ISO 11138-2-2006;ISO/TS 11139-2006;ISO 11140-1-2005;ISO 11607-1-2006;ISO 11607-2-2006;ISO 11737-1-2006;ISO |
采用关系: |
DIN EN ISO 11135-2014,IDT;ANSI/AAMI/ISO 11135-2015,IDT;BS EN ISO 11135-2014,IDT;EN ISO 11135-2014,IDT;JIS T 0801-2016,IDT;CAN/CSA-Z11135-2015,IDT;SN EN ISO 11135-2014,IDT;OENORM EN ISO 11135-2014,IDT;OENORM EN ISO 11135-2015,IDT;PN-EN ISO 11135-2014,IDT;PN-EN ISO 11135-2015,IDT;SS-EN ISO 11135-2014,IDT;UNE-EN ISO 11135-2015,IDT;DS/EN ISO 11135-2014,IDT;UNI EN ISO 11135-2014-2014,IDT;STN EN ISO 11135-2015,IDT;CSN EN ISO 11135-2015,IDT;DS/EN ISO 11135-2014,IDT;NEN-EN-ISO 11135-2014 en-2014,IDT |
内容提要(EN): |
Acceptance (approval);Acceptance specification;Checks;Commissioning;Definitions;Ethylene oxide;Evaluations;Examination (quality assurance);Germicides;Hygiene;Inspection;Instructions;Maintenance;Medical devices;Medical equipment;Medical products;Medical sciences;Medical technology;Microbiological analysis;Operation;Operators (personnel);Personnel;Public health;Public health protection;Qualifications;Quality management;Routine tests;Safety;Safety engineering;Safety requirements;Specification (approval);Sterilization (birth control);Sterilization (hygiene);Sterilizers;Storage;Surveillance (approval);Testing;Validation;Bearings |
归属: |
国际 |
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