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 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. This International Standard does not apply to ⎯ electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24; ⎯ implantable devices; ⎯ enteral feeding pumps; ⎯ transdermal delivery devices; ⎯ devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).