Despite the potential for harm, standards makers had not appreciated the need to promote robust calibration procedures in requirements for syringes used with infusion devices.

A revised standard ISO 7886-2:2020 was published in April 2020, incorporating concepts for measurement uncertainty in its Annex A: Short term flow accuracy, including reference to EURAMET Calibration Guide 19 and GUM – Guide for uncertainty in measurements. Additional metrological requirements addressed water density calculations rather than a fixed value, calculations considering evaporation and buoyancy corrections, and defined ambient conditions specifications, instrument thermostabilization and equipment specifications. In June 2020, the US FDA stated that its recognition of ISO 7886-2:1996 would be superseded by ISO 7886-2:2020, and significantly, following a transition period that ended in July 2021, would only accept premarket submissions claiming conformity to the revised standard.

https://www.euramet.org/casestudies/casestudiesdetails/news/calibration-best-practice-in-standards/