Portable Appliance Testing of Medical Devices

[JoCam]

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

 

[yodon]

Hate to see a good question go unanswered, so here goes.

Instead of trying to answer the question, though, maybe we think about it from a different perspective. Is the equipment you use qualified and appropriate to perform the test? Is the data captured to the required degree of accuracy? Can the data be relied upon (i.e., is the equipment calibrated / able to be calibrated)?

In 13485, 7.5.1, they address general requirements for such equipment (along with required records from conducting the activity).

 

[JoCam]

Thank you Yodon,

The pumps are manufactured to the design that was approved by our NB for CE mark, during which time electrical testing was performed to 60601-1. I therefore believe that basic PAT equipment will not be giving the required results to the degree of accuracy necessary. I don't have a copy of IEC 62353, but I feel I may need to get hold of a copy to establish exactly what our requirements are for ensuring electrical safety of the pumps after servicing or repair.

Jo

 

[Pads38]

Hi Jo,

You haven't stated what type and classification your device is.

Class 1 or 2?
Applied parts? B/BF/CF?

Key tests from 60601 are the leakage current tests, particularly of parts that are in patient contact. These tests would, typically, be repeated after maintenance / repair and would not be tests that a simple PAT tester could perform.

There is a useful guide to 62353 available here:-
http://www.rigelmedical.com/Includes/get_download.php?id=154

(Free - but registration required)

And, of course, they sell test gear suitable for both 62353 and 60601.
Disclosure - no connection except as a customer.

 

[JoCam]

Thank you Pads 38,

Our device is class IIa and applied part B.

Jo