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Clause 4.7 of Third Edition IEC 60601-1 is the policy clause on single fault condition for medical device equipment. During any test under single fault condition, only one fault at a time shall be applied. In today's blog, the discussion will explore how risk analysis shall be used to determine which failures shall be tested.
The single fault conditions of Clause 13 of Third Edition IEC 60601-1, along with the single faults in the Risk analysis need to be considered for testing. Why? If there is a failure in any one component that could lead to a hazardous situation, then the test must simulate the failure – physically or theoretically. Once this happens, the evaluation determines whether a component is subject to failure simulation which will take into account the risk associated with the failure during the expected service life of the actual medical device.
All evaluations under this clause must be achieved by application of the risk management principles. More specifically, the evaluation has to factor in key issues like reliability, tensile safety factors and rating of components.
"It's important to make sure that any component failures likely to occur over the expected service life are performed," said Todd Konieczny, North American Medical Technical Leader. "By doing this, all potential failures are tested and the application of risk management principles are accomplished."
To learn more about Third Edition and or to speak with an Intertek expert on this subject matter, e-mail us at ThirdEdition@intertek.com