how to describe the computer in the productregistration? - 分享质量人的知识和经验

登录

1: 关注

1091: 浏览

how to describe the computer in the productregistration?

医疗器械技术评审

If the active medical device is used with acomputer how to describe the computer in the productregistration?

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 22:19

If the active medical device is used with a general-purposecomputer, the computer may not be an composition components ofthe product, but the requirements of the computer shall be describedin the product technical requirements and product instructions.

The product technical requirements shall specify the hardwareconfiguration, software environment and network conditions of thecomputer, in which the minimum requirements shall be specified forthe hardware configuration and network conditions, and the minimumrequirements and compatibility requirements shall be specified forthe software environment. In addition to the above description, theproduct manual shall also indicate that the computer shall meet therelevant requirements of medical electrical system (GB 9706.15) andelectromagnetic compatibility(YY 0505).

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

364: 问题

问题动态

发布时间: 2023-09-17 22:18

更新时间: 2023-09-17 22:19

关注人数: 1 人关注

相关问题

Why would a design space beverified during the product lifecycle?: 1058 浏览 1 关注 1 回答 0 评论

Can the cybersecurity descriptiondocument be submitted within the software descriptiondocument?: 1153 浏览 1 关注 1 回答 0 评论

What are the requirements for adding models oraccessories in the Change of Permission Items?: 1220 浏览 1 关注 1 回答 0 评论

How can I find out the expiry date of an EDQM reference standard?: 1062 浏览 1 关注 1 回答 0 评论

How should blank forms be controlled?: 1194 浏览 1 关注 1 回答 0 评论

How to determine the essential performance ofimmunity test in EMC test of active medical devices?: 987 浏览 1 关注 1 回答 0 评论

Is it acceptable to only save the final results from reprocessed laboratory chromatography?: 1044 浏览 1 关注 1 回答 0 评论

the transducer and surgicalinstruments can be connected into other manufacturesmain engine?: 1151 浏览 1 关注 1 回答 0 评论

could the software information in the devicecertificate be updated during Registration Renewal?: 1047 浏览 1 关注 1 回答 0 评论

不同水处理设备如何解决TOC超标？如何解决ORP过高？: 7563 浏览 1 关注 1 回答 0 评论

推荐内容

问 GB/T 25000.51-2016 《系统与软件工程系统与软件质量要求和评价（SQuaRE）第51部分：就绪可用软件产品（RUSP）的质量要求和测试细则》检测报告是否可以提交自检报告？: 532 浏览 1 关注 1 回答 0 评论

问 changingthe center thickness of soft contact lenses?: 1071 浏览 1 关注 1 回答 0 评论

问定量检测体外诊断试剂的精密度试验设计，是否要对各影响因素进行单独评估？: 1031 浏览 1 关注 1 回答 0 评论

问注射用交联透明质酸钠凝胶产品应如何参考YY/T 0308《医用透明质酸钠凝胶》中的剪切黏度、特性黏数、重均分子量及分子量分布系数有关要求?: 804 浏览 1 关注 1 回答 0 评论

问神经和心血管介入导管类产品导管座如何进行生物学评价？: 1304 浏览 1 关注 1 回答 0 评论

问产品技术要求附录内容需要变更，能否在延续注册过程中进行更改？: 1043 浏览 1 关注 1 回答 0 评论

问基台类产品进行临床评价时，如申报产品材质为合金(Ti6A4V )，是否可以选择纯材质(TA4)产品作为同品种医疗器械进行比对?: 1198 浏览 1 关注 1 回答 0 评论

问 doesthe original model need to be implemented with the newstandard requirements?: 1256 浏览 1 关注 1 回答 0 评论

问目前可以参考的共性产品分类界定相关指导原则有哪些？: 1046 浏览 1 关注 1 回答 0 评论

问呼吸机类产品的注册单元应如何划分？: 176 浏览 1 关注 1 回答 0 评论

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