ISO 11135-1:2007
衛生保健品滅菌.環氧乙烷.第1部分:醫療設備消毒過程的制定、確認和常規控制的要求

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

作廢

ISO 11135-1:2007 發布歷史

ISO 11135-1:2007由國際標準化組織 IX-ISO 發布于 2007-05。

ISO 11135-1:2007 在中國標準分類中歸屬于: C47 公共醫療設備，在國際標準分類中歸屬于: 11.080.20 消毒劑和防腐劑。

本標準有等同采用的 中文版 GB 18279.1-2015 醫療保健產品滅菌 環氧乙烷 第1部分:醫療器械滅菌過程的開發、確認和常規控制的要求

ISO 11135-1:2007 衛生保健品滅菌.環氧乙烷.第1部分:醫療設備消毒過程的制定、確認和常規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 發布之時，引用了標準

• ISO 10012 測量管理系統.測量方法和測量設備的要求
• ISO 10993-1 醫療器械的生物學評價. 第1部分: 在風險管理過程內的評價與試驗*， 2018-08-01 更新
• ISO 10993-7 醫療器械的生物學評價.第7部分:環氧乙烷滅菌殘留物.勘誤表1*， 2009-11-01 更新
• ISO 11138-1:2006 醫療保健產品滅菌.生物指示物.第1部分:一般要求
• ISO 11138-2:2006 醫療保健產品滅菌.生物指示物.第2部分:環氧乙烷滅菌同生物指示劑
• ISO 11140-1 保健產品的滅菌.化學指示劑.第1部分:一般要求*， 2014-11-01 更新
• ISO 11737-1 保健產品的滅菌.微生物方法.第1部分:產品上微生物種群的測定.修改件1*， 2021-05-19 更新
• ISO 11737-2 醫療器械的滅菌 - 微生物方法 - 第2部分:滅菌過程的定義 驗證和維護中進行的無菌檢測*， 2019-12-02 更新
• ISO 13485:2003 醫療器械.質量管理系統.管理目標的要求
• ISO 14161 醫療保健產品滅菌.生物指示物.選擇,使用及檢驗結果判斷指南*， 2009-09-01 更新
• ISO 14937:2000 醫療保健產品滅菌 消毒劑的特性及醫療裝置消毒的開發、確認和程序控制的一般要求

* 在 ISO 11135-1:2007 發布之后有更新，請注意新發布標準的變化。

ISO 11135-1:2007的歷代版本如下：

• 2007年 ISO 11135-1:2007 衛生保健品滅菌.環氧乙烷.第1部分:醫療設備消毒過程的制定、確認和常規控制的要求

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 的發行版本有：

• DS/EN ISO 11135-1:2007 保健品滅菌-環氧乙烷-第1部分：醫療器械滅菌過程的開發、驗證和常規控制要求
• KS P ISO 11135-1-2014 保健品滅菌.環氧乙烷
• KS P ISO 11135-1:2014 保健品滅菌 環氧乙烷

標準號

ISO 11135-1:2007

發布

2007年

中文版

GB 18279.1-2015 (等同采用的中文版本)

發布單位

國際標準化組織

當前最新

ISO 11135-1:2007

 

 

引用標準

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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