J
Dear Covers,
I'm currently facing a problem which I guess many other Medical device manufacturers have had.
It concerns a medical device, classified as IIa (for EU), containing some IT components.
For the CE approval our Test laboratory has performed testing and an assesment according IEC60601-1 and stumbled upon the following:
The single board computer and the LCD with inverter have documents or certificates claiming they are electrically safe according a standard such as IEC-EN 60950 or UL 1950.
I've tried to get the information from our supplier but they could not help me. Only specification sheets and EMC test reports and declarations but nothing on electrical safety.
I've also tried the manufacturers directly but I got the same info.
The Test Lab then suggested we get the schematics from the manufacturers so the lab can judge the electrical circuits of the High Voltage part of the LCD and inverter and the same for the battery on the single board computer.
Surprisingly
the manufacturers are not very keen on sharing their schematics...
Or the certificates/declarations of our competitors tests showing the components are safe.
Now, I've been trying to get some form of evidence that these components are tested, produced or even designed electrically safe for almost two months now.
No luck!!
Though the components are from really large international electrical components manufacturers???
They do have comprehensive reports and certificates regarding EMI, EMC, mechenicas shock testing etc...
But nothing on electrical sagety or compliance to the Low voltage directive?
Can anybody comment please or share their experience on this?
Not being sure if this is the right sub forum to post this question, moderators could perhaps move it to a forum with more expertise if needed.
Regards, Jerome
I'm currently facing a problem which I guess many other Medical device manufacturers have had.
It concerns a medical device, classified as IIa (for EU), containing some IT components.
For the CE approval our Test laboratory has performed testing and an assesment according IEC60601-1 and stumbled upon the following:
The single board computer and the LCD with inverter have documents or certificates claiming they are electrically safe according a standard such as IEC-EN 60950 or UL 1950.
I've tried to get the information from our supplier but they could not help me. Only specification sheets and EMC test reports and declarations but nothing on electrical safety.
I've also tried the manufacturers directly but I got the same info.
The Test Lab then suggested we get the schematics from the manufacturers so the lab can judge the electrical circuits of the High Voltage part of the LCD and inverter and the same for the battery on the single board computer.
Surprisingly
the manufacturers are not very keen on sharing their schematics...Or the certificates/declarations of our competitors tests showing the components are safe.
Now, I've been trying to get some form of evidence that these components are tested, produced or even designed electrically safe for almost two months now.
No luck!!
Though the components are from really large international electrical components manufacturers???
They do have comprehensive reports and certificates regarding EMI, EMC, mechenicas shock testing etc...
But nothing on electrical sagety or compliance to the Low voltage directive?
Can anybody comment please or share their experience on this?
Not being sure if this is the right sub forum to post this question, moderators could perhaps move it to a forum with more expertise if needed.
Regards, Jerome
