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BS ISO 28620:2020

BS ISO 28620:2020

$102.76

Medical devices. Non-electrically driven portable infusion devices

Published By Publication Date Number of Pages
BSI 2020 20
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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).

PDF Catalog

PDF Pages PDF Title
2 undefined
6 Foreword
7 1 Scope
2 Normative references
8 3 Terms and definitions
9 4 General requirements
4.1 Components
10 4.2 Materials
4.3 Design and characteristics
4.3.1 General
4.3.2 Fittings
4.3.3 Filter
4.3.4 Tubing
4.3.5 Reservoir
4.4 Sterility and non-pyrogenicity
11 5 Operating requirements
5.1 Flow rate
5.2 Bolus, if applicable
6 Test methods
6.1 Test conditions
6.1.1 General
6.1.2 Apparatus and reagents
6.1.3 Operating conditions
12 6.2 Determination of the flow rate
6.2.1 Principle
6.2.2 Apparatus
6.2.3 Procedure
13 6.2.4 Expression of results
6.3 Resistance to pressure
6.4 Drop test method
14 6.5 Water-tightness of the components of the device
6.6 Resistance to traction of the entire device
6.7 Bolus volume
6.8 Refill time
15 6.9 Test for efficiency of the fluid filter
6.9.1 Preparation of the test fluid
6.9.2 Procedure
16 6.9.3 Expression of results
7 Information to be listed on packaging and/or product
17 8 Accompanying documents
18 Bibliography

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BS ISO 28620:2020
$102.76