Hi,

I am working for ISO13485 before but this round I have new product range - Paper used for plotting chart. As you know, this product will not directly contact with patient and it only used to plot the chart (e.g. heart beat, blood pressure ). So far, I know it does not required clean room condition. What it needs are only the paper and ink used during printing... Does anyone has any opinion of this?

TQ:bigwave:

Hi,

I am working for ISO13485 before but this round I have new product range - Paper used for plotting chart. As you know, this product will not directly contact with patient and it only used to plot the chart (e.g. heart beat, blood pressure ). So far, I know it does not required clean room condition. What it needs are only the paper and ink used during printing... Does anyone has any opinion of this?

TQ:bigwave:


I do not much requiremnets on these b ut my :2cents: is that the paper should not be the thermal paper or else, the data will fade away.

Non thermal papers are good for storage for long times.