The medical device industry is the most heavily regulated in
manufacturing, for good reason. Devices that do not meet the highest quality
and safety standards present a risk of injury, recalls, embargos, bans and
The transition from IEC 60601-1-2:2007 to IEC 60601-1-2:2014
introduced the concept and application of risk management (carried over from
the IEC 60601-1:2005+A1:2012) and shifts the testing requirements to the
manufacturer. The change in responsibility forces the manufacturer to
play a more active role in the EMC evaluation. The role of risk
management is provided to allow for the modification of testing dependent on
the intended use location. With the addition of risk management, the test
house conducting the testing will be looking at the manufacturer to provide
clear direction not only on the tests to conduct, voltage to run the unit, what
to look for during/after testing and locations to run the tests. With the
change in edition, the accompanying document requirements have changed which
will require modifications to the documentation.
In order to prevent delays in your IEC 60601-1-2:2014
evaluation, a understanding of the requirements is critical. During this
½ day class, we will discuss the addition of Risk Management, Test Plan and
Accompanying Document Requirement.
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