ISO 28620:2020

Medical devices - Non-electrically driven portable infusion devices

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).

Dispositifs médicaux — Diffuseurs portables de médicaments, non mus électriquement

General Information

• Status: Published
• Publication Date: 15-Jan-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
• Current Stage: 9060 - Close of review
• Completion Date: 02-Sep-2030

Relations

• Revises: ISO 28620:2010 - Medical devices - Non-electrically driven portable infusion devices
• Effective Date: 21-Oct-2017

Overview

ISO 28620:2020 - Medical devices - Non-electrically driven portable infusion devices - specifies essential requirements and test methods for portable infusion devices that do not use electrical power. It covers devices intended for continuous (fixed or adjustable) flow and/or bolus delivery for neuraxial and intravascular/hypodermic applications. The standard applies to devices used in healthcare and non‑healthcare settings, whether filled by the manufacturer, a clinician or the patient.

Key topics and requirements

• Scope exclusions: does not apply to electrically driven pumps (IEC 60601‑2‑24), implantable devices, enteral or transdermal delivery systems, single‑bolus devices covered by ISO 11608, or gravity‑only systems.
• Core components: must include a means to convert non‑electric energy to fluid flow, a flow restrictor, a reservoir and a particulate filter. Additional features may include adjustable flow systems, filling ports, lock connectors, clamps, bolus systems, tubing and air‑elimination features.
• Materials and biocompatibility: materials in contact with drug solutions require biological evaluation in accordance with ISO 10993‑1.
• Connectors and fittings: fittings must conform to ISO 80369‑1, and where applicable ISO 80369‑6 (neuraxial) and ISO 80369‑7 (intravascular/hypodermic).
• Filter performance: particulate filter retention when tested per the standard shall be not less than 80% for latex particles.
• Design and performance: device design must meet declared nominal flow rate, mean and instantaneous flow characteristics, bolus volume and refill time requirements.
• Testing methods: includes procedures for determination of flow rate, resistance to pressure, drop testing, water‑tightness, resistance to traction, bolus volume, refill time and fluid filter efficiency.
• Labelling and documentation: requirements for marking, nominal volumes, nominal bolus/refill times, packaging information and accompanying instructions for use.

Applications and users

ISO 28620:2020 is used by:

• Medical device manufacturers designing and validating non‑electrically driven infusion devices (wearable or portable infusion systems).
• Design and quality engineers for establishing performance and testing protocols.
• Regulatory and compliance teams preparing technical documentation for market approval.
• Test laboratories conducting conformity and performance testing per specified methods.
• Healthcare procurement and clinical staff evaluating device suitability for neuraxial or intravascular therapy in hospital, outpatient or home care settings.

Related standards

• ISO 10993‑1 - Biological evaluation of medical devices
• ISO 80369‑1, ‑6, ‑7 - Small‑bore connectors for healthcare applications
• IEC 60601‑2‑24 and ISO 11608 series (not covered by ISO 28620; referenced for excluded device types)

Keywords: ISO 28620:2020, non‑electrically driven portable infusion devices, infusion device standards, neuraxial infusion, intravascular infusion, flow rate testing, filter efficiency, ISO 80369, ISO 10993‑1.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 28620
Second edition
2020-01
Medical devices — Non-electrically
driven portable infusion devices
Dispositifs médicaux — Diffuseurs portables de médicaments, non
mus électriquement
Reference number
©
ISO 2020
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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below or ISO’s member body in the country of the requester.
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Published in Switzerland
ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 Components . 3
4.2 Materials . 4
4.3 Design and characteristics . 4
4.3.1 General. 4
4.3.2 Fittings . 4
4.3.3 Filter . 4
4.3.4 Tubing . 4
4.3.5 Reservoir . . 4
4.4 Sterility and non-pyrogenicity . 4
5 Operating requirements . 5
5.1 Flow rate . 5
5.2 Bolus, if applicable . 5
6 Test methods . 5
6.1 Test conditions . 5
6.1.1 General. 5
6.1.2 Apparatus and reagents . 5
6.1.3 Operating conditions . 5
6.2 Determination of the flow rate . 6
6.2.1 Principle . 6
6.2.2 Apparatus . 6
6.2.3 Procedure . 6
6.2.4 Expression of results . 7
6.3 Resistance to pressure . 7
6.4 Drop test method . 7
6.5 Water-tightness of the components of the device . 8
6.6 Resistance to traction of the entire device . 8
6.7 Bolus volume . 8
6.8 Refill time . 8
6.9 Test for efficiency of the fluid filter . 9
6.9.1 Preparation of the test fluid . 9
6.9.2 Procedure . 9
6.9.3 Expression of results .10
7 Information to be listed on packaging and/or product .10
8 Accompanying documents .11
Bibliography .12
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 28620:2010), which has been technically
revised. The main changes compared with the previous edition are as follows:
— the Scope has been amended to explicitly cover neuraxial and intravascular or hypodermic
applications;
— the requirements on components and their fittings have been aligned with the appropriate parts of
the ISO 80369 series, i.e. ISO 80369-1, ISO 80369-6 and ISO 80369-7;
— the requirements on filter and tubing have been updated;
— a test method for the efficiency of the fluid filter has been added;
— Table 1, which gives information to be provided by the manufacturer, has been updated.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

INTERNATIONAL STANDARD ISO 28620:2020(E)
Medical devices — Non-electrically driven portable
infusion devices
1 Scope
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).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors
for neuraxial applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
bolus
discrete volume of solution that is delivered in a short time
3.2
bolus refill time
time required to refill the emptied bolus device to the bolus volume
3.3
nominal bolus refill time
bolus refill time (3.2) indicated by marking on the device or its packaging
3.4
filling volume
nominal volume (3.10) plus residual volume (3.5)
3.5
residual volume
volume remaining in the device and applicable components after the completion of infusion
3.6
instantaneous flow rate
ratio between a volume administered and the time necessary to administer it
Note 1 to entry: It is expressed in millilitres per hour (ml/h).
3.7
mean flow rate
ratio between the nominal volume (3.10) and the actual time for administration
Note 1 to entry: It is expressed in millilitres per hour (ml/h).
3.8
nominal time
time for administering the nominal volume (3.10)
3.9
nominal flow rate
ratio between the nominal volume (3.10) and nominal time (3.8)
Note 1 to entry: It is expressed in millilitres per hour (ml/h).
3.10
nominal volume
volume indicated by marking on the device or its packaging
3.11
nominal bolus volume
bolus volume indicated by marking on the device or its packaging
2 © ISO 2020 – All rights reserved

3.12
device
portable infusion device
equipment intended for the controlled infusion of liquids into the patient and intended to be carried or
worn by the patient
3.13
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (3.14) and its
contents from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.14
sterile barrier system
minimum package that prevents the ingress of microorganisms and allows aseptic presentation of the
product at the point of use
4 General requirements
4.1 Components
The device shall contain the following components:
— means to convert non-electric energy into fluid flow;
— a flow restrictor;
— a reservoir designed to contain the solution to be administered;
— a particulate matter filter in the fluid path.
NOTE 1 These components can be integrated or delivered separately.
The device may also contain one or more of the following components (non-exhaustive list):
— a system to adjust the flow rate;
— a filling port preferably with check valve;
NOTE 2 The filling port is intended for use in the pharmacy during filling only and can be a Luer type
female geometry in accordance with ISO 80369-7.
— a lock connector at the distal end of the tubing conforming to ISO 80369-6 or ISO 80369-7, as
appropriate for the intended application;
— a clamp to stop the flow if necessary;
— a sterility protector, e.g. Luer cap, at the distal end of the tubing and of the filling site;
— a system to administer a bolus with a means for controlling the maximum amount of solution
infused over time;
— a protective element of the reservoir, preventing the drug solution from flowing out should the
reservoir break or leak (which can be necessary to fulfil the leakage test in 6.4 and 6.5);
— a means of indicating the end of infusion;
NOTE 3 This can be achieved by a visual, audible or other indication.
— administration tubing;
...