1
关注
1255
浏览

Medical endoscopes have several models, how tochoose the typical model for type test?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:32

Generally, the following factors should be taken into accountin the selection of typical endoscopes in one registration unit:For endoscopes with different view angles, the model with themaximum view angle should be selected.
For endoscopes with different field of view angles, the modelwith the maximum and minimum field of view angles should beselected.

For endoscopes with different inner diameter, outer diameterand working length, the model with the smallest diameter and thelargest slender ratio (length divide diameter) should be selectedIf containing working channel, the diameter should be the outerdiameter of insert minus the inner diameter of working channel.For different optical performance (such as angular resolutionetc.), the model with the highest performance should be selected.


关于作者

问题动态

发布时间
2023-09-17 22:31
更新时间
2023-09-17 22:32
关注人数
1 人关注

推荐内容

对于进口无菌或植入类医疗器械,在提交其注册申请前,是否需要注册人完成PQ(性能验证/确认)吗?
YY 0286.1-2019中药液过滤器排气孔细菌截留性能评价方法如何选择?
is it not applicable to the cybersecurityrequirement?
体外诊断试剂自测产品注册时说明书可以注册两个版本么,即一个用于专业医疗机构人员使用,一个用于非专业背景的人员自测使用?
球囊扩张导管产品技术要求中额定爆破压指标应如何制定?
体外诊断试剂产品分析性能评估资料应提供哪些基本信息?
第二类有源产品的研发过程中何时需要进行联合使用的研究?
ERPS系统中用户名+密码登录方式和数字证书+密码登录方式的区别是什么?
How to determine the essential performance ofimmunity test in EMC test of active medical devices?
产品本身不在免于临床试验的目录中,但已有多个同类产品上市。本公司产品比同类上市产品多脉搏、血氧、额温采集功能,临床评价还是否可以走同品种比对路径?