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AAMI ISO 10993-7:2008 (R2012)现行

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
标准编号: AAMI ISO 10993-7:2008 (R2012)
发布时间:2012/6/1 0:00:00
标准类别:Standard
出版单位:Association for Advancement of Medical Instrumentation
标准页数:114
标准简介

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.

标准备注

Supersedes AAMI ST29 and AAMI ST30 (07/2002) Supersedes AAMI TIR 19. (01/2009)

等同采用的国际标准

ISO 10993-7:2008 - Identical

ISO 10993-7 : 2008(R2016) - Identical