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  • BSI
    BS ISO 28620:2020 Medical devices. Non-electrically driven portable infusion devices
    Edition: 2020
    $316.70
    / user per year

Description of BS ISO 28620:2020 2020

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).



Standard NumberBS ISO 28620:2020
TitleMedical devices. Non-electrically driven portable infusion devices
StatusDefinitive
Publication Date2020-01-20
ReplacesBS ISO 28620:2010
Identical National Standard OfISO 28620
DescriptorsPerformance, Tubing (medical), Containers, Performance testing, Instructions for use, Conical fittings (syringes), Medical equipment, Product information, Parenteral infusion equipment, Pumps, Liquids, Drug administration, Portable
ICS11.040.20 Transfusion, infusion and injection equipment
CommitteeCH/212
ISBN978 0 580 99682 5
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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