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UNI EN ISO 11135 : 2014现行

STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

出版:Ente Nazionale Italiano di Unificazione (UNI)

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基本信息
标准编号: UNI EN ISO 11135 : 2014
标准类别:Standard
出版单位:Ente Nazionale Italiano di Unificazione (UNI)
标准页数:0
标准简介

Defines 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 recognizes the similarities and differences between the two applications.

本标准替代的旧标准

UNI CEN ISO/TS 11135-2 : 2009

等同采用的国际标准

EN ISO 11135 : 2014 COR 2014 - Identical

ISO 11135 : 2014 - Identical

EN ISO 11135 : 2014 COR 2014 - Identical

ISO 11135 : 2014 - Identical