首页
问答
文章
专栏
话题
更多
帮助
专题
请输入关键字进行搜索
查看更多 "
" 的搜索结果
登录
中文
英文
ku1314520
一阶会员
这家伙还没有留下自我介绍
保密
关注: 35
|
粉丝: 37
|
积分: 368
|
威望: 0
|
访问: 4474
动态
提问 17
回答 46
文章 2
关注的人
关注TA的
关注的专栏
关注的话题
ku1314520
在 2023-09-17 22:42 回答了问题
医疗器械技术评审
Do we need the control groupin the animal experiment?
ku1314520
:
The animal experiment mainly provides evidence for thefinalization of product design, provides the evidence for the medicaldevice to enter the clinica...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:40 回答了问题
医疗器械技术评审
medical X-ray diagnostic equipment ( ClassIII)?
ku1314520
:
Please refer to the“Guidance for product registrationtechnical review of medical X-ray diagnostic equipment (Class Il ”Clinical parts usually include ...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:39 回答了问题
医疗器械技术评审
predicate medical device in clinicalevaluation?
ku1314520
:
Software difference may cause difference in productperformances,clinical functions and core algorithms. Accordingto the“Guidance for clinical evaluati...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:37 回答了问题
医疗器械技术评审
can we onlycompare the key performances?
ku1314520
:
Comparison with predicate medical device in clinicalevaluation for active medical device, what content to be comparedis relevant to the product featur...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:36 回答了问题
医疗器械技术评审
Under what circumstances do environmentatests need to be carried out on medical electricalequipment?
ku1314520
:
If the medical electrical equipment is expected to be used ina special environment (such as high temperature, high humidity orlow temperature), or if ...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:35 回答了问题
医疗器械技术评审
When submit Change of Permission Items foradding models, is it necessary for type testing?
ku1314520
:
First, it is necessary to identify whether the adding modelscan be regarded as the same registration unit with the originalmodels. If so, application ...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:34 回答了问题
医疗器械技术评审
can theelectrical safety and electromagnetic compatibility test beexempted?
ku1314520
:
The change of the shell structure and the overall sealingperformance of the equipment may lead to the change of theelectrical safety and electromagnet...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:32 回答了问题
医疗器械技术评审
Medical endoscopes have several models, how tochoose the typical model for type test?
ku1314520
:
Generally, the following factors should be taken into accountin the selection of typical endoscopes in one registration unit:For endoscopes with diffe...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:31 回答了问题
医疗器械技术评审
Do medical optical endoscope and laser fiberoptics need to be tested for EMC?
ku1314520
:
Both medical optical endoscope and laser fiber opticsbelongs to the applied part of medical electric equipment. They don'have main supply connection. ...
赞同
0
反对
0 人感谢
0 评论
1 回复
ku1314520
在 2023-09-17 22:30 回答了问题
医疗器械技术评审
Do wireless accessories of the active medicaldevices need to be tested during the EMC test?
ku1314520
:
Whether the active medical device accessories need to betested for EMC has nothing to do with the connection form of theproduct, which mainly depends ...
赞同
0
反对
0 人感谢
0 评论
1 回复
«
1
2
3
4
5
»
个人成就
获得 0 次赞同
被 37 人关注了
关注了 35 人
技术支持
WeCenter
© 2024
粤ICP备2023143277号-1
关于我们
社区规范
反馈举报
网上有害信息举报
12315投诉举报平台
网络不良信息举报中心
网络谣言曝光台
你的浏览器版本过低,可能导致网站部分内容不能正常使用!
为了能正常使用网站功能,请使用以下浏览器
Chrome
Firefox
Safari
IE 10+