1
关注
1040
浏览

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

查看全部 1 个回答

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

How to determine the service life of active medicaldevices?
丙型肝炎病毒核糖核酸测定试剂临床试验中,对于不同型别覆盖如何考虑?
企业新产品注册申请时,如省内尚无该类产品,但外省已有该类产品注册、上市,是否可以直接参照外省,简化分类界定相关流程?
纯钦或镇合金材料的骨科植入器械经着色阳极氧化处理后,如产品表面除基体元素外还含有残留杂质元素应如何进行生物学评价?
申请分类界定时提交的产品名称应符合哪些要求?
用于对患者起支撑和固定作用的无源附件是否可以和设备一起申报?
包类产品的分类编码如何来确定?
已上市医疗器械产品通过何种方式更改说明书中禁忌证?
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?
子公司在外省已获批注册的第二类医疗器械在北京进行注册,申报产品第三方检测报告是子公司名称,注册时是否需要重新检测?