标准摘要
[中文适用范围]： 1 范围 本文件规定了环氧乙烷（EO）灭菌医疗器械中残留环氧乙烷（EO）和乙二醇氯醇（ECH）的允许限值（AL），以及测定EO和ECH的方法，并提供了判定合规性的方法，以确保器械可放行。附件A至K包含了与本文件应用相关的背景信息，包括指导说明和流程图。本文件不适用于既无直接也无间接人体或使用者接触的EO灭菌器械或组件（例如体外诊断器械）。本文件也不适用于已证实不吸收或不保留EO或其降解产物ECH的器械，例如完全由金属合金和玻璃制成的医疗器械，详见C.5条[228]。注：本文件未规定乙二醇（EG）的限值。由于附件F中的风险评估表明，计算出的允许水平高于医疗器械中可能出现的水平，因此未对EG设定限值。 [外文原描述]： This document specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in Annexes A , B , C , D , E , F , G , H , I , J and K . EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see Clause C.5 [228] . NOTE This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in Annex F indicates that calculated allowable levels are higher than those likely to occur in a medical device.
英文名称Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals