BS EN ISO 10993-7-2008 医疗器械的生物学评估.环氧乙烷灭菌残留量

标准号：BS EN ISO 10993-7-2008
中文标准名称：医疗器械的生物学评估.环氧乙烷灭菌残留量
英文标准名称：Biological evaluation of medical devices - Ethylene oxide sterilization residuals
标准类型：C30
发布日期：2008/12/31 12:00:00
实施日期：2008/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：11.100.20
适用范围：This part of ISO 10993 specifies 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, andmethods for determining compliance so that devices may be released. Additional background, includingguidance and a flowchart showing how this document is applied, are also included in the informative annexes.EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by thispart of ISO 10993.