ISO 28620:2010

ISO 28620:2010 specifies essential requirements and related test methods for non-electrically driven portable infusion devices. It applies to devices designed for continuous (fixed or adjustable) flow and/or for bolus application.
These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.
These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.