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SS EN ISO 11135 Ed. 1 (2014)現(xiàn)行

Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices (Iso 11135:2014)

出版:Standardiserings-Kommissionen I Sverige

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基本信息
標(biāo)準(zhǔn)編號: SS EN ISO 11135 Ed. 1 (2014)
發(fā)布時(shí)間:2014/7/24 0:00:00
標(biāo)準(zhǔn)類別:Standard
出版單位:Standardiserings-Kommissionen I Sverige
標(biāo)準(zhǔn)頁數(shù):100
標(biāo)準(zhǔn)簡介

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 it acknowledges the similarities and differences between the two applications.

標(biāo)準(zhǔn)備注

Supersedes SS EN ISO 11135-1 & SIS CEN ISO/TS 11135-2. (08/2014)

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

SIS CEN ISO/TS 11135-2 Ed. 1 (2009)

SS EN ISO 11135-1 Ed. 1 (2007)