
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
出版:German Institute for Standardisation (Deutsches Institut für Normung)

专家解读视频
基本信息
标准编号: DIN EN ISO 10993-7 : 2009
发布时间:2009/1/1 0:00:00
标准类别:Standard
出版单位:German Institute for Standardisation (Deutsches Institut für Normung)
标准页数:113
标准简介
Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.
等同采用的国际标准
ISO 10993-7 : 2008(R2016) - Identical