Calibration of Dose Area Product (DAP) Meter in our Class IIb X-Ray Medical Device

Kuldeep Singh

Involved In Discussions
#1
Hi everyone!

We are using Dose Area product (DAP) Meter in our X-Ray Medical Device as a accessory which shows radiation dose. No doubt its a measuring function and fall within Essential safety requirement MDD 93/42/EEC. So as per MDD requirement we have to define its accuracy and perform yearly calibration on every machine for this DAP Meter. So i have few queries ,

1. is it necessary to pasted a calibration sticker having cal date and its due date on this machine?
2.What should we define in our information for use regarding this meter?
3. It is a difficult task to calibrate the DAP meter on every machine.
4. Should we consider it as measuring function as the intended use of our product doesnt based upon the result which it shows.It is only for reference for user that how much dose you give to patient.

Please clarify if anyone can. Thanks in advance
 
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dgrainger

Trusted Information Resource
#2
I don't think it actually is an accessory!
It doesn't seem to "enable" the x-ray device. You state that it can function without it. it's only recording patient dose.
DAP's are required by ionising radiation regulations.
 
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