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PREN ISO 11135:2011被替代

Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices (Iso/Dis 11135:2011)

出版:Comite Europeen de Normalisation

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基本信息
标准编号: PREN ISO 11135:2011
发布时间:2011/9/1 0:00:00
标准类别:Draft
出版单位:Comite Europeen de Normalisation
标准页数:87
标准简介

Gives requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

等同采用的国际标准

NEN EN ISO 11135:2011 - Identical

NEN EN ISO 11135:2012 - Identical

NF EN ISO 11135:2012 - Identical