November 30, 2015
UL staff member, Bob DeLisi recently attended the ASC C63® standards meeting responsible for voluntary standards relating to EMC in the United States. FDA was present at this meeting and presented information about the recent EMC guidance document “Information to Support a Claim of EMC of Electrically-Powered Medical Devices.” The new Guidance was issued because the 9 items mentioned had previously been listed on the website with the requirements and transitions for IEC 60601-1-2 but when the website was updated they were removed. The Guidance reconfirms previous practices used by UL to provide sufficient and high quality EMC test evidence and documentation in FDA submissions.
The items include:
- A summary of the testing that was performed to support EMC; 104 105 B. the specifications of the standard that were met (including immunity test levels);
- The specifications of the standard that were met (including immunity test levels);
- The device-specific pass/fail criteria used (this includes how the pass/fail criteria were derived)
- The specific functions of the device that were tested (e.g., for IEC 60601-1-2, this should include performance that was determined to be essential performance) and how these fluctuations were monitored:
- The performance of the device during each test, indicating if the device met the 115 emissions and immunity pass/fail criteria;
- An identification of and a justification for any of the standard’s allowances that were used
- A description of and justification for any deviations from the specifications of the referenced standard. The justification should explain how the deviations would not compromise the safety and effectiveness (performance) of the device;
- the device labeling and evidence of compliance with the reference standard's labeling (identification, marking and documents) specifications; and
- A detailed description of all changes or modifications that were made to the device in order to pass any of the EMC tests. If modifications were made, a statement should be included indicating that the changes or modifications will be incorporated into the final production model and documented in the design history file in accordance with design controls.
DeLisi confirmed at the meeting that the first 8 items in the Guidance under “EMC Information” are listed to help ensure the FDA receives the necessary information, in the test report submitted, clearly describes how testing was conducted and how a particular product was evaluated. The ninth item is listed to help ensure that if an EMC lab makes changes during testing that the manufacturer ensure the changes are implemented in production. Many times EMC reports will document the changes but then they are not implemented during production.