Hi All,
The product we manufacture on-site at our facility is CE marked and was fully tested to applicable electrical safety standards during the design phase, ie. 60601-1. We also service and repair the product on-site, a part of which includes Portable Appliance Testing of the equipment, which leads me into my question; Does the portable appliance test equipment we use need to be the more expensive equipment designed for testing medical devices, being as this has already been done during the verification activities, or can we use a general PAT tester?
Regards,
Jo
The product we manufacture on-site at our facility is CE marked and was fully tested to applicable electrical safety standards during the design phase, ie. 60601-1. We also service and repair the product on-site, a part of which includes Portable Appliance Testing of the equipment, which leads me into my question; Does the portable appliance test equipment we use need to be the more expensive equipment designed for testing medical devices, being as this has already been done during the verification activities, or can we use a general PAT tester?
Regards,
Jo