Understanding Essential Performance for IEC 60601-1 Third Edition
Blog tags: Medical and Pharmaceutical; Medical Devices
May 23, 2011
Essential Performance is not new to the Third Edition, it is more defined – the performance necessary to achieve freedom from unacceptable risk. In the Second Edition, the Essential Performance was covered in clause 3.1, but not in detail. Essential Performance was indirectly covered by the performance criteria outlined in Clauses 50 and 51 of the Second Edition-based 60601-2-x particular standards.
However, the Essential Performance in the Third Edition is a requirement for compliance. Why? Essential performance functions could lead to an unacceptable risk. The IEC 60601-1 Third Edition standard also notes that "essential performance exists when the feature or function in question is either absent or its characteristics are degraded to a point that the ME equipment is no longer suitable for its intended use."
While the 3rd Edition of IEC 60601-1 now includes EP requirements, the manufacturer's EP requirements may vary from the standard's, depending on the proposed use of the device. For example a patient hoist has 2 performance functions: Raising the patient and lowering the patient. Through risk analysis it would demonstrate that not being able to lift the patient is an acceptable risk – but at the same time – not being able to lower the patient is an unacceptable risk. That said, only lowering the patient is the Essential Performance function.
"In the Third Edition, not all performance functions will be considered as Essential Performance the RMF," said Todd Konieczny, North American Medical Technical Leader. "More specifically, any performance function that leads to an unacceptable risk per the RMF is Essential Performance."
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