If The Active Medical Device Is Used With A Computer, How To Describe The Computer In The Product Registration?
2022-10-20
If the active medical device is used with a general-purpose computer, the computer may not be an composition components of the product, but the requirements of the computer shall be described in the product technical requirements and product instructions.
The product technical requirements shall specify the hardware configuration, software environment and network conditions of the computer, in which the minimum requirements shall be specified for the hardware configuration and network conditions, and the minimum requirements and compatibility requirements shall be specified fbr the software environment. In addition to the above description, the product manual shall also indicate that the computer shall meet the relevant requirements of medical electrical system (GB 9706.15) and electromagnetic compatibility (YY 0505).
