Technical File - Updating Applied Standards

Al Rosen

Al Rosen

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#1
#1
If you make a change to your device do you maintain the applied standard in the list or delete it from the list.
For example: The device originally included a laser positioning system and it has been changed to eliminate it. Do you remove the applicable standard?
 
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shimonv

shimonv

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#2
#2
I would say yes, providing you don't have installed system using the obsolete technology. If you do, then I would keep it because some of the test reports in the Technical File probably make reference to the standard.
 
Watchcat

Watchcat

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#4
#4
Hi Al, glad to see you are still with us! Does that mean you didn't have COVID-19 or you got through it with relatively mild symptoms?
 
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