BS EN ISO 10993-7 是英国标准学会(GB-BSI)发布的一项关于医疗器械生物学评价的标准,该标准于2024年6月17日发布并开始实施,标准号为24/30453916 DC。该标准主要关注医疗器械在环氧乙烷灭菌后残留量的评估和控制,以确保医疗器械在使用过程中的安全性。 环氧乙烷(EO)是一种常用的灭菌剂,广泛用于医疗器械的灭菌过程...
BS EN ISO 10993-7-2008+A1-2022 BS EN ISO 10993-7-2008+A1-2022 格式:PDF 页数:98 上传日期:2022-02-21 13:36:18 浏览次数:1000 下载积分:3000 加入阅读清单 还剩97 页未读,是否继续阅读? 此文档由 1720小猫咪.. 分享于 2022-02-21...
BS EN ISO 10993-7:2008+A1:2022 适用范围 ISO 10993 的这一部分规定了单个 EO 灭菌医疗器械中环氧乙烷 (EO) 和氯乙烯 (ECH) 残留量的允许限值、EO 和 ECH 的测量程序以及确定合规性以便放行器械的方法。其他背景信息,包括指导和显示如何应用本文件的流程图,也包含在信息性附件中。 ISO 10993 的本部分不...
BSENISO10993‑7:008+A1:0—TrackedChangescomparesBSENISO10993‑7:008+A1:0withBSENISO10993‑7:1996Biologicalevaluationofmedicaldevices—EthyleneoxidesterilizationresidualsIStandardsPublicationBSIStandardsPublicationBSENISO13850:015—TrackedChangescom
BS EN ISO 10993-7 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices. It also gives procedures for the measurement of EO and ECH, and methods for determining compliance so that devices can be released. The stand...
BS EN ISO 10993-17:2009
BS EN ISO10993-12:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 12: Sample preparation andreference materials (ISO 10993-12:2007)
BS EN ISO 10993-17:2023 购买 正式版 本文件规定了医疗器械成分毒理学风险评估的流程和要求。还规定了用于评估接触某种成分是否不会造成明显危害的方法和标准。毒理学风险评估可以作为最终产品生物学评估的一部分,如 ISO 10993-1 所述。本文件中描述的过程适用于根据 ISO 10993-18 获得的化学特性信息。当需要对...
To reduce the likelihood of adverse reactions and ultimately to make medical devices safer, BS EN ISO 10993-10:2023 Biological evaluation of medical devices — Part 10: Tests for skin sensitization specifies procedures for assessing devices and their constituent materials for their potential to induce...
BS EN ISO10993-1:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 1: Evaluation and testing (ISO10993-1:2003)Licensed copy: Vocational Trading Council, Vocational Training Council, Version correct as of ...