Experiences with testing according to IEC 60601-1 3rd ed.
The 3rd edition of the IEC 60601-1 standard includes a host of new requirements for both medical device manufacturers and testing laboratories, and has significantly increased the level of documentation required on both sides. Even though the publication of this standard dates back more than nine years, medical device manufacturers are still providing incomplete or unclear documentation of some of its aspects. In many cases, this concerns the definition of essential performance and risk management.
The operational and ruling documents “OD-2044 Evaluation of Risk Management in medical electrical equipment according to the IEC 60601-1 & IEC/ISO 80601-1 Series of Standards” and “OD-2055 Guideline Document on Medical Electrical Equipment in the CB Scheme according to the IEC 60601 and IEC/ISO80601 Series of Standards” brought noticeable improvements. However, manufacturers are still uncertain when it comes to the definition of essential performance requirements and risk management.
Definition of “essential performance requirements”
Some of the particular standards for individual medical devices (“Part 2 standards”, IEC 60601-2-X) specify essential performance requirements. However, in the majority of cases, manufacturers must define these requirements via their risk management process. The definition of “essential performance”, as provided in Clause 3.27 of IEC 60601-1, 3rd edition, shows that essential performance refers not to basic safety, but to a clinical function whose degradation or loss beyond a limit set by the manufacturer results in an unacceptable risk. This also applies in case of “first failure” condition (see Clause 4.3 of IEC 60601-1, 3rd edition).