ISO 11135-1:2007
卫生保健品灭菌.环氧乙烷.第1部分:医疗设备消毒过程的制定、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

作废

ISO 11135-1:2007 发布历史

ISO 11135-1:2007由国际标准化组织 IX-ISO 发布于 2007-05。

ISO 11135-1:2007 在中国标准分类中归属于: C47 公共医疗设备，在国际标准分类中归属于: 11.080.20 消毒剂和防腐剂。

本标准有等同采用的 中文版 GB 18279.1-2015 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

ISO 11135-1:2007 卫生保健品灭菌.环氧乙烷.第1部分:医疗设备消毒过程的制定、确认和常规控制的要求的最新版本是哪一版？

最新版本是 ISO 11135-1:2007 。

ISO 11135-1:2007 发布之时，引用了标准

• ISO 10012 测量管理系统.测量方法和测量设备的要求
• ISO 10993-1 医疗器械的生物学评价. 第1部分: 在风险管理过程内的评价与试验*， 2018-08-01 更新
• ISO 10993-7 医疗器械的生物学评价.第7部分:环氧乙烷灭菌残留物.勘误表1*， 2009-11-01 更新
• ISO 11138-1:2006 医疗保健产品灭菌.生物指示物.第1部分:一般要求
• ISO 11138-2:2006 医疗保健产品灭菌.生物指示物.第2部分:环氧乙烷灭菌同生物指示剂
• ISO 11140-1 保健产品的灭菌.化学指示剂.第1部分:一般要求*， 2014-11-01 更新
• ISO 11737-1 保健产品的灭菌.微生物方法.第1部分:产品上微生物种群的测定.修改件1*， 2021-05-19 更新
• ISO 11737-2 医疗器械的灭菌 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中进行的无菌检测*， 2019-12-02 更新
• ISO 13485:2003 医疗器械.质量管理系统.管理目标的要求
• ISO 14161 医疗保健产品灭菌.生物指示物.选择,使用及检验结果判断指南*， 2009-09-01 更新
• ISO 14937:2000 医疗保健产品灭菌 消毒剂的特性及医疗装置消毒的开发、确认和程序控制的一般要求

* 在 ISO 11135-1:2007 发布之后有更新，请注意新发布标准的变化。

ISO 11135-1:2007的历代版本如下：

• 2007年 ISO 11135-1:2007 卫生保健品灭菌.环氧乙烷.第1部分:医疗设备消毒过程的制定、确认和常规控制的要求

This part of ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE 2 See for example ISO 22442-1, ISO 22442-2 and ISO 22442-3. This part of ISO 11135 does not detail a specified requirement for designating a medical device as sterile. NOTE 3 Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for example EN 556-1 or ANSI/AAMI ST67. This part of ISO 11135 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 4 The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this part of ISO 11135 to have a complete quality management system during manufacture or reprocessing, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see in particular Clause 4). National and/or regional regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party. This part of ISO 11135 does not specify requirements for occupational safety associated with the design and operation of ethylene oxide sterilization facilities. NOTE 5 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist. NOTE 6 Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used. This part of ISO 11135 does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene oxide directly into individual product packages, or continuous sterilization processes.

采用 ISO 11135-1 的发行版本有：

• DS/EN ISO 11135-1:2007 保健品灭菌-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
• KS P ISO 11135-1-2014 保健品灭菌.环氧乙烷
• KS P ISO 11135-1:2014 保健品灭菌 环氧乙烷

标准号

ISO 11135-1:2007

发布

2007年

中文版

GB 18279.1-2015 (等同采用的中文版本)

发布单位

国际标准化组织

当前最新

ISO 11135-1:2007

 

 

引用标准

ISO 10012 ISO 10993-1 ISO 10993-7 ISO 11138-1:2006 ISO 11138-2:2006 ISO 11140-1 ISO 11737-1 ISO 11737-2 ISO 13485:2003 ISO 14161 ISO 14937:2000

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