1
关注
1081
浏览

what aspects should beconsideredin the application materials?

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 22:44

For large-scale imaging equipment (such as CT,MRPET/CT,etc.), if the third-party physiological gating interface isprovided, such as respiratory gating interface, ECG gating interfaceetc., the administrative counterparts shall specify the relevantrequirements of the third-party gating equipment that can be usedtogether in the overview material, such as interface type (includingconnection mode, data protocol, etc.), standards that shall be met,etc.. If the interface is special, the manufacturer, product model, etc.of the equipment that can be used together shall be specified; theverification and validation data tested together with the third-partyequipment shall be provided in the research data; the interface type(including connection mode, data protocol, etc.) and the standard (ifapplicable) shall be specified in the product technical requirements.the technical parameters related to gating shall be tested.


关于作者

问题动态

发布时间
2023-09-17 22:43
更新时间
2023-09-17 22:44
关注人数
1 人关注

相关问题

How often should audit trails be reviewed?
What are the requirements for conducting visual inspection as per Q&A 7?
What is “metadata”?
How should manufacturers use the HBELs?
What is the scope of the EDQM ISO 9001 certificate?
How should design spaceverification protocol be addressed in the submission?
What reference standards does the EDQM supply?
What should be included in the research data ofactive medical devices service life?
What are the requirements for adding models oraccessories in the Change of Permission Items?
What are the storage conditions for EDQM reference standards?