This International Standard specifies essential requirements and related test methods for non-electrically driven portable infusion devices1). It applies to devices designed for continuous (fixed or adjustable) flow and/or for bolus application.These devices may be used in health care and non-health care settings. They may be applied or administered by health care professionals or by the intended patient.These devices may be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.This standard does not apply to. electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24;