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
專家解讀視頻
基本信息
標準編號： AAMI ISO 10993 7:1995 (R2001)
發布時間：1995/12/1 0:00:00
標準類別：Standard
出版單位：Association for Advancement of Medical Instrumentation
標準頁數：30
標準簡介
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.
標準備注
To be used in conjunction with AAMI TIR 19 Supersedes AAMI ST29 and AAMI ST30 (07/2002)
替代本標準的新標準
等同采用的國際標準
ISO 10993-7:1995 - Identical
