
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
出版:Association for the Advancement of Medical Instrumentation

专家解读视频
基本信息
标准编号: AAMI ISO 10993-7 : 2008
标准类别:Standard
出版单位:Association for the Advancement of Medical Instrumentation
标准页数:0
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.
本标准替代的旧标准
等同采用的国际标准
ISO 10993-7 : 2008(R2016) - Identical