
Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
出版:Association for Advancement of Medical Instrumentation

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基本信息
標準編號: AAMI ISO 10993-7:2008 (R2012)
發布時間:2012/6/1 0:00:00
標準類別:Standard
出版單位:Association for Advancement of Medical Instrumentation
標準頁數:114
標準簡介
Provides allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.
標準備注
Supersedes AAMI ST29 and AAMI ST30 (07/2002) Supersedes AAMI TIR 19. (01/2009)