AAMI ISO 10993 7:1995 (R2001)被替代
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 7:1995 (R2001)
发布时间：1995/12/1 0:00:00
标准类别：Standard
出版单位：Association for Advancement of Medical Instrumentation
标准页数：30
标准简介
Defines allowable limits for residual ethylene oxide and ethylene chlorohydrin in individual EO-sterilized medical devices, procedures for measurement of EO and ECH, and methods for determining compliance so that devices may be released. FDA Recognized (recognition stipulates must be used with new AAMI Technical Information Report, TIR19:1998), which provides additional guidance.
标准备注
To be used in conjunction with AAMI TIR 19 Supersedes AAMI ST29 and AAMI ST30 (07/2002)
替代本标准的新标准
等同采用的国际标准
ISO 10993-7:1995 - Identical
