標準號：BS EN ISO 10993-7-2008
中文標準名稱：醫療器械的生物學評估.環氧乙烷滅菌殘留量
英文標準名稱：Biological evaluation of medical devices - Ethylene oxide sterilization residuals
標準類型：C30
發布日期：2008/12/31 12:00:00
實施日期：2008/12/31 12:00:00
中國標準分類號：C30
國際標準分類號：11.100.20
適用范圍：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.