ISO 11608-6:2022

INTERNATIONAL ISO
STANDARD 11608-6
First edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 6:
On-body delivery systems
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d'essai —
Partie 6: Systèmes d'administration sur le corps
Reference number
© ISO 2022
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 General . 3
4.2 Risk assessment . 3
4.3 Usability engineering . . 3
4.4 Uncertainty of measurement and conformance with specifications . 3
4.5 General design requirements . 3
4.6 Physical or mechanical requirements and test methods . 3
4.6.1 General . 3
4.6.2 Systems comprising rigid needles . 3
4.6.3 Systems comprising a soft cannula(s) . 3
4.6.4 Leakage from the OBDS . 3
4.6.5 Means of attachment. 4
4.6.6 Occlusion . 4
4.7 Functional performance requirements and test methods . 5
4.7.1 General . 5
4.7.2 Dosing requirements and methods . 5
4.7.3 Sharps injury protection . 6
4.7.4 Automated functions . 6
4.7.5 Injection depth and needle extension . 7
4.8 Biological requirements of the OBDS . 7
4.8.1 Sterility of OBDS . 7
4.8.2 Biocompatibility . 7
4.9 Medicinal product compatibility . 7
4.9.1 General . 7
4.9.2 Particulates . 7
4.9.3 Pyrogenicity . 7
4.9.4 Extractable/leachables . 7
4.10 Electrical safety and software requirements . 8
4.10.1 Electrical safety . 8
4.10.2 Software . 8
5 Inspection . 8
6 Information supplied by the manufacturer . 8
Annex A (informative) Test methods for adhesion . 9
Annex B (informative) Dose delivery profiles .10
Annex C (informative) In vitro methods in relation to needle/cannula displacement .16
Bibliography .17
iii
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
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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 84, Devices for administration of medicinal
products and catheters.
A list of all parts in the ISO 11608 series can be found on the ISO website.
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
Introduction
The ISO 11608 series has traditionally addressed hand-held needle-based injection systems (NISs)
that are intended for parenteral administration by injection of medicinal products through a needle
to humans. These injections are performed manually, through exertion of force by the user, or
automatically through use of an internal power source through a needle into the patient’s tissue.
NOTE Although technically a device using a soft cannula is not “needle-based”, the cannula is placed by a
needle and can be included in this classification.
The user typically places the hand-held NIS at the injection site and holds the NIS in place until the
injection has completed. The intended use and delivery requirements of some medicinal products can
make manual manipulation and stabilization of a hand-held NIS during the medicinal product delivery
process impractical or impossible, and can result in an incomplete dose, missed dose, or user injury.
For example, it might not be appropriate, practical or possible for users to hold a NIS in place for an
extended period of time required by the volume or viscosity of the medicinal product or required to
preclude patient discomfort.
Delivery systems that are affixed to the body of the user eliminate some of the risks associated with
delivery of medicinal product through a traditional NIS. This document provides a consistent method
for evaluating the unique requirements and risks associated with these systems, herein referred to as
"on-body delivery systems" (OBDS).
Similarly to ISO 11608-1 and ISO 11608-5, this document will tend to specify the results of the design
effort instead of the physical and construction requirements used as the basis for OBDS design, so that
innovation in achieving the intended purposes is not unnecessarily restricted.
NISs governed by the ISO 11608 series are defined as “hand-held” or “on-body” delivery systems (OBDSs).
When hand-held, patients control and stabilize the NIS at the injection site during administration of a
discrete volume. Delivery times for this type of NIS would, therefore, be limited to avoid instability and
the potential for injection site trauma. For NISs with larger delivery volumes or physical properties
requiring a longer time to deliver, OBDS might be more practical. The OBDS would likely exist as either
“body-worn” (directly anchored to the body, e.g. using adhesive) or “patient-worn” (indirectly anchored,
e.g. catheter attached to OBDS contained in a backpack or pocket).
In either configuration, the time or speed employed to deliver a discrete volume would be based upon
patient tolerability or patient convenience rather than clinical relevance (e.g. medication efficacy) as
would be the case with insulin patch pumps or traditional infusion pumps associated with continuous
delivery (e.g. insulin).
This document only addresses the basic safety and performance of the product and manufacturers can
through risk assessments, identify additional requirements due to the unique nature of their specific
system or application.
The sampling plans for inspection selected for this document and outlined in ISO 11608-1 are intended
to verify the design, at a high confidence level. The sampling plan does not replace the more general
manufacturing quality systems, including lot release, which appear in International Standards on
quality systems, e.g. ISO 9001 or ISO 13485.
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INTERNATIONAL STANDARD ISO 11608-6:2022(E)
Needle-based injection systems for medical use —
Requirements an
...