Serial number

Serial numbers allow traceability of individual units, which matters for implants, service history and field actions. Under UDI rules the serial number can be part of the production identifier.

production control containing a combination of letters or numbers, selected by the manufacturer, intended for quality control and identification purposes to uniquely distinguish an individual medical device from other medical devices with the same catalogue number or model number [SOURCE: ISO 20417:2021,[15] 3.22]

ISO 15223-1:2021, clause 3.15

production control containing a combination of letters or numbers, selected by the manufacturer, intended for quality control and identification purposes to uniquely distinguish an individual medical device from other medical devices with the same catalogue number or model number [SOURCE: ISO 14708-2:2012[12], 3.20, modified — added ‘production control containing a’, replaced ‘and/or’ with ‘or’ and ‘to distinguish a device from other devices with the same model designation’ with ‘for quality control and identification purposes to distinguish an individual medical device from other medical devices with the same catalogue number or model number’.]

ISO 20417:2021, clause 3.22