1
关注
1079
浏览

what aspects should beconsideredin the application materials?

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 22:44

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

What if unexpectedresults/events are obtained during the design space verification studies?
What should be included in the research data ofactive medical devices service life?
Who should review audit trails?
What are the “systems” in “computer or related systems” in § 211.68?
How should access to CGMP computer systems be restricted?
How should design spaceverification protocol be addressed in the submission?
What is an “audit trail”?
How should manufacturers use the HBELs?
What is the meaning of “Unit Quantity”?
What is the scope of the EDQM ISO 9001 certificate?