how to describe the computer in the productregistration? - 分享质量人的知识和经验

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how to describe the computer in the productregistration?

医疗器械技术评审

If the active medical device is used with acomputer how to describe the computer in the productregistration?

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ku1314520 一阶会员用户来自于: 广东省深圳市
2023-09-17 22:19

If the active medical device is used with a general-purposecomputer, the computer may not be an composition components ofthe product, but the requirements of the computer shall be describedin the product technical requirements and product instructions.

The product technical requirements shall specify the hardwareconfiguration, software environment and network conditions of thecomputer, in which the minimum requirements shall be specified forthe hardware configuration and network conditions, and the minimumrequirements and compatibility requirements shall be specified forthe software environment. In addition to the above description, theproduct manual shall also indicate that the computer shall meet therelevant requirements of medical electrical system (GB 9706.15) andelectromagnetic compatibility(YY 0505).

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发布时间: 2023-09-17 22:18

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