NBN ISO 28620:2021

This document specifies essential requirements and related test methods for non-electrically driven
portable infusion devices, thereafter called “device”.
It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial
and intravascular or hypodermic applications.
NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles
of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered
regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial
plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds
with local anaesthetic agents.
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 document does not apply to
— electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24,
— devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that
are covered by the ISO 11608 series,
— implantable devices,
— enteral devices,
— transdermal delivery devices, and
— 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).