How to determine the essential performance ofimmunity test in EMC test of active medical devices? - 分享质量人的知识和经验

登录

1: 关注

570: 浏览

How to determine the essential performance ofimmunity test in EMC test of active medical devices?

医疗器械技术评审

How to determine the essential performance ofimmunity test in EMC test of active medical devices?

好问题 0 评论收藏举报

您还未登录!暂时最多只可查看 1 条回答

去登录! 还没有账号?去注册

1 回答

ku1314520 一阶会员用户来自于: 广东省深圳市
2023-09-17 22:26

“Essential performance’ refers to the achievement ofperformance of a clinical function, other than that related to BASICSAFETY, where loss or degradation beyond the limits specified bythe manufacture results in an unacceptable riskWhen determining the essential performance of the product,the administrative counterparts shall consider but not limited to thefollowing aspects:

(1) Clinical safety risk;

(2) Performance related to diagnosis/treatment/ monitoring;

(3) Whether the performance of various sensors,cables,application parts, control devices, display devices, moving parts, etc.are affected by electromagnetic interference.

The essential performance shall be reflected in theaccompanying document (product specification) of the product, andthe identified essential performance shall be tested for immunityIf the essential performance is not identified, all functions of theproduct shall be taken as the essential performance for immunity test.

赞同 0 0评论

关于作者

: 小懒虫 二阶会员
这家伙很懒，还没有设置简介

312: 回答

135: 文章

383: 问题

问题动态

发布时间: 2023-09-17 22:25

更新时间: 2023-09-17 22:26

关注人数: 1 人关注

相关问题

how to describe the computer in the productregistration?: 552 浏览 1 关注 1 回答 0 评论

doesthe original model need to be implemented with the newstandard requirements?: 658 浏览 1 关注 1 回答 0 评论

If the Android APP is registered, isit necessary to be tested when adding iOS APP?: 601 浏览 1 关注 1 回答 0 评论

现在注射剂项目建设过程中，在线TOC的安装位置是在纯化水还是注射用水的分配系统，这个有什么规定吗？安装在注射用水分配回水末端，有问题吗？: 2766 浏览 2 关注 1 回答 0 评论

对于无菌生产的产品，应在哪个生产环节进行生物负载监测（bioburden monitoring）？: 434 浏览 1 关注 1 回答 0 评论

How does FDA use the terms “static” and “dynamic” as they relate to record formats?: 479 浏览 1 关注 1 回答 0 评论

How should design spaceverification approach be addressed in the pharmaceutical quality system?: 441 浏览 1 关注 1 回答 0 评论

How do the new requirements affect importers of medicinal products?: 475 浏览 1 关注 1 回答 0 评论

When submit Change of Permission Items foradding models, is it necessary for type testing?: 687 浏览 1 关注 1 回答 0 评论

If medical device software is updated, when willit need to submit Change of Permission Items?: 566 浏览 1 关注 1 回答 0 评论

推荐内容

问 the question abaot of non-medical device components?: 652 浏览 1 关注 1 回答 0 评论

问注册申请人委托具备相应条件的企业生产医疗器械，委托方对受托方质量管理体系进行审核时应关注哪些内容？: 718 浏览 1 关注 1 回答 0 评论

问 If medical device software is updated, when willit need to submit Change of Permission Items?: 566 浏览 1 关注 1 回答 0 评论

问 Under what circumstances do environmentatests need to be carried out on medical electricalequipment?: 583 浏览 1 关注 1 回答 0 评论

问通用型激光光纤注册单元划分应注意哪些方面？: 651 浏览 1 关注 1 回答 0 评论

问弹力包扎敷料的技术要求的性能指标制定只参考YY/T 1467-2016 《医用包扎敷料救护绷带》标准制定可以吗？: 697 浏览 1 关注 1 回答 0 评论

问医疗器械洁净环境检测的要求和适用标准是什么？: 623 浏览 1 关注 1 回答 0 评论

问口腔材料生物学评价中，哪些生物学试验需要采用两种浸提介质?亚慢性毒性试验对样品要求量较大，是否只考虑一种浸提介质即可?: 607 浏览 1 关注 1 回答 0 评论

问主要生产车间布置图有何要求？: 578 浏览 1 关注 1 回答 0 评论

问同品种医疗器械临床数据除临床文献数据外，还可包括哪些方面?: 404 浏览 1 关注 1 回答 0 评论

技术支持 WeCenter © 2024 粤ICP备2023143277号-1