Expected lifetime

ISO 20417 uses expected lifetime as the main term and expected service life as an alternative. For software it can be relative, for example the time between two major releases.

time period specified by the manufacturer during which the medical device or accessory (3.1) is expected to remain safe and effective for use Note 1 to entry: The expected lifetime can be affected by the stability. Note 2 to entry: Maintenance, repairs or upgrades (e.g., safety or cybersecurity modifications) can be necessary during the expected lifetime. Note 3 to entry: Some medical devices have an absolute lifetime (e.g., 5 y), whereas other medical devices (e.g., software) have a relative lifetime (e.g., the time between two major releases). Note 4 to entry: There is guidance or rationale for this definition contained in Clause A.2. [SOURCE: IEC 60601-1:2005+AMD1: 2012[2], 3.28, modified — added alternative term. The reference to ‘me equipment or me system’ has been replaced with ‘medical device’, the parenthetical has been deleted and the notes added.]

ISO 20417:2021, clause 3.7