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Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015

Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing.

AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”.  This report is available from AAMI at http://my.aami.org/store/SearchResults.aspx?searchterm=62354&searchoption=ALL. This document is identical to the IEC TR 62354:2014 published last September, and gives detailed guidance to manufacturers, test houses, and other interested parties on the steps involved in the safety testing of medical electrical equipment.  It builds on the test requirements of IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 but goes much further into testing details.  Examples of the content of the TIR include a description of the power supply needed for testing, the sequence of testing, the test equipment needed for each test, production-line tests, and much more.

This Report is not normative — which means it is not mandatory — however it gives excellent guidance and should be read and used by any laboratory interested in accurate, repeatable testing of medical electrical equipment or manufacturer and other interested parties in learning more about how the tests are conducted when their product goes to a test lab for IEC 60601-1 Certification Testing.  

If you need additional support for any of the IEC 60601 series of standards please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).