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A few years ago, we registered a Class III (US Class II) device and used UL60601-1 1st edition and the following as standards:
CSA C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety
CSA 22.2 No. 61010.1-4
We are modifying our device and will need to test our device again. Does anyone know if the two CSA standards listed above are still valid or they have been updated to other versions?
In case these standards have changed and/or new standards have been added for Class III devices, would you please include the the full title and date on which the standard become mandatory?
CSA C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety
CSA 22.2 No. 61010.1-4
We are modifying our device and will need to test our device again. Does anyone know if the two CSA standards listed above are still valid or they have been updated to other versions?
In case these standards have changed and/or new standards have been added for Class III devices, would you please include the the full title and date on which the standard become mandatory?