Expected service life

The expected service life is set by the manufacturer and drives risk management, durability testing, maintenance instructions and post-market data. Maintenance during that period can be part of keeping the device safe.

time period specified by the MANUFACTURER during which the MEDICAL DEVICE is expected to remain safe for use (i.e. maintain basic SAFETY and essential performance) Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE. [SOURCE: IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.28, modified – In the definition, ‘ME EQUIPMENT and ME SYSTEM’ have been replaced with ‘MEDICAL DEVICE’.]

IEC 62366-1:2015+AMD1:2020, clause 3.6