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.

Cross References:
ISO 80369-1
ISO 80369-7
ISO 80369-6
ISO 15223-1
ISO 10993-1
EN 1041
EN 556-1
ISO 554
IEC 60601-2-24
ISO 17665-1
ISO 11137 (all parts)
ISO 11607-1
ISO 11135
ISO 11608 (all parts)
ISO 14937
ISO 10555-1
EN 13868
ANSI/AAMI ST67
ISO 11139:2018


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