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PREN ISO 11135 : DRAFT 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
標(biāo)準(zhǔn)編號(hào): PREN ISO 11135 : DRAFT 2011
標(biāo)準(zhǔn)類別:Draft
出版單位:Comite Europeen de Normalisation
標(biāo)準(zhǔn)頁(yè)數(shù):0
標(biāo)準(zhǔn)簡(jiǎn)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.

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

EN ISO 11135 : 2014 COR 2014