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
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 2.1 MB |
| ISBN(s) : | 9780580996825 |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 20 |
| Product Code(s) : | 30372088, 30372088, 30372088 |
| Published : | 01/20/2020 |
