DIN EN ISO 10993-7-2009 医疗装置的生物学评定 第7部分:环氧乙烷灭菌残留物

标准号：DIN EN ISO 10993-7-2009
中文标准名称：医疗装置的生物学评定 第7部分:环氧乙烷灭菌残留物
英文标准名称：Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); English version of DIN EN ISO 10993-7:2009-02
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 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.NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).