Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1
医疗保健产品的消毒 环氧乙烷 ISO 11135-1应用指南

2009-07-31

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
医疗保健产品的灭菌环氧乙烷第2部分:ISO 11135-1的应用指南

2009-09-02

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
医疗保健产品的灭菌.环氧乙烷.第1部分:医疗器械灭菌过程的开发 验证和常规控制的要求（ISO 11135-1-2007）；德文版EN ISO 11135-1:2007

2007-08-01

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
医疗保健产品的灭菌.环氧乙烷.第1部分:医疗器械灭菌过程的开发 验证和常规控制要求（ISO 11135-1-2007）

2007-10-24

BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11135 医疗保健产品的消毒 环氧乙烷 医疗器械灭菌过程的开发、验证和常规控制要求

2004-05-24

Change summary for 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 11135:2014《医疗保健产品的灭菌——环氧乙烷——医疗器械灭菌过程的开发、验证和常规控制要求》的变更摘要

2016-08-09

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135:2014, second edition, 2014-07-15)
医疗保健产品的灭菌.环氧乙烷.医疗器械灭菌过程的开发、验证和常规控制要求（采用ISO 11135:2014 第二版 2014-07-15）

2015-11-01

医疗保健产品灭菌　环氧乙烷　第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求
Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

2015-12-10

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
医疗保健产品的灭菌.生物指示剂.第2部分:环氧乙烷灭菌过程用生物指示剂（ISO 11138-2-2006）

2009-09-09

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
修订附件E 单批次释放

2018-10-15