发布时间：2024-05-27 17:49:26 - 更新时间：2024年06月29日 15:22
点击量：0
有样品要送检？试试一键送检，5分钟极速响应
在线提交检测需求
对接客服咨询检测
本标准规定了材料选择、设计和加工、材料试验。为选择环氧乙烷灭菌的材料适应性提供评价指南。 本标准适用于采用环氧乙烷灭菌的医疗器械的材料评价
Evaluation of materials of medical device subject to ethylene oxide sterilization
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (First Edition)
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
本文件从质量管理体系、安全和环境保护、灭菌过程控制和监视、变更和不合格控制以及重新灭菌等方面，对环氧乙烷灭菌生产过程控制提出了明确要求和指导，用于指导自行灭菌的医疗器械制造商和分包灭菌商，以规范环氧乙烷灭菌过程的管理。本规范文件中除适用范围、规范性引用文件、术语和定义及参考文献部分外，其它部分的
Ethylene oxide sterilization process practice of sterile medical device
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023)
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019)
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release
GB 18279的本部分规定了医疗器械环氧乙烷灭菌过程的开发、确认和常规控制的要求。 按照本部分要求确认和控制的灭菌过程不可推断为可有效灭活海绵状脑病的致病因子，如羊瘙痒病、牛海绵状脑病和克雅氏病。有些国家已制定了处理可能受此类因子污染物质的详细建议。 本部分未详述标示为菌的医疗器械具体要求
Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices -- Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018
Sterilization of heal th care products-ethylene oxide part 1:requirements for development,validation and routine control of a sterilization process for medical devices
This standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
本标准规定了材料选择、设计和加工、材料试验。为选择环氧乙烷灭菌的材料适应性提供评价指南。 本标准适用于采用环氧乙烷灭菌的医疗器械的材料评价
Evaluation of materials of medical device subject to ethylene oxide sterilization
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (First Edition)
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
本文件从质量管理体系、安全和环境保护、灭菌过程控制和监视、变更和不合格控制以及重新灭菌等方面，对环氧乙烷灭菌生产过程控制提出了明确要求和指导，用于指导自行灭菌的医疗器械制造商和分包灭菌商，以规范环氧乙烷灭菌过程的管理。本规范文件中除适用范围、规范性引用文件、术语和定义及参考文献部分外，其它部分的
Ethylene oxide sterilization process practice of sterile medical device
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023)
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019)
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release
GB 18279的本部分规定了医疗器械环氧乙烷灭菌过程的开发、确认和常规控制的要求。 按照本部分要求确认和控制的灭菌过程不可推断为可有效灭活海绵状脑病的致病因子，如羊瘙痒病、牛海绵状脑病和克雅氏病。有些国家已制定了处理可能受此类因子污染物质的详细建议。 本部分未详述标示为菌的医疗器械具体要求
Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices -- Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018
Sterilization of heal th care products-ethylene oxide part 1:requirements for development,validation and routine control of a sterilization process for medical devices
This standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
首页
点击咨询
