Functional and single fault safety in medical devices 

Under regulatory requirements all medical electrical equipment is expected to comply with the IEC 60601 standard series in order to ensure its safety and freedom from unacceptable risks. In accordance with IEC 60601-1 the safety of medical electrical equipment covers basic safety and essential performance (EP).

Where essential performance is concerned, the standard requires single fault safety but contains no specifications on how to achieve a safe state in case of faults, failures and single fault condition (SFC). Instead, it only refers to the risk management files in which the manufacturer is intended to specify the risks for which tests must be performed to ensure single fault safety. An analysis of incidents (or near-incidents) based on the Manufacturer and User Facility Device Experience (MAUDE) database carried out by a Notified Body shows that incidents related to EP in a fault condition have occurred even if the medical devices were tested and certified according to the regulatory requirements referring to the IEC 60601 standard series.

From the regulatory perspective, single fault safety is specifically required by the European Medical Device Regulation (MDR, Regulation 2017/745) in General Safety and Performance Requirement (GSPR) 14.3, GSPR 17.1, GSPR 18.1 and GSPR 18.7. Prominent references of single fault safety of medical devices in four different essential requirements proves how important this function is from the legislative perspective.

In this talk we provide information on the standardisation initiative for single fault safety in the IEC  60601 series, where the call for experts was just announced. We deliver an update on the standardisation progress, provide insights into how other areas outside the medical field deal with single fault conditions and give practical advice on how medical device manufacturers can implement the requirements of MDR on single fault safety.

Date and time: Tuesday, 18 May 2021, 6.30 pm (CEST)

Your speakers: Alba Marina Malavé Dos Santos, Senior Product Specialist Functional Safety

                             Abtin Rad, Global Director Functional Safety & Software

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