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Surgical angle measurement guide device with an application software

M

mails4seroth

Registered
#1
#1
Hello everyone,
I am currently working on a surgical angle measurement guide device that attaches to surgical tools and, sends data to a tablet (iPad), to displays the angle of measurements during surgery using proprietary application software. The software provides essential functionality for the safety of the patient, but the tablet is not being supplied with the equipment. How do I address this according to the IEC 60601-1 medical standard, especially considering the requirements of clause 14.

Thanks
 
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Y

yodon

Staff member
Super Moderator
#2
#2
For the sake of 60601-1 testing, I don't think the tablet comes into play (you may want to have a chat with a test lab). Risk (14971), usability (62366), and software (62304) compliance will be assessed and I'm sure there would be expectations for those aspects to be addressed.
 
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