National foreword

This British Standard is the UK implementation of ISO 11608‑6:2022.

The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2022.

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 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.

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.

1 Scope

This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.

NOTE 1 Although technically a device using a soft cannula is not “needle-based”, the soft cannula is placed by a needle and can be included in this classification.

NOTE 2 Some requirements and methods are already established and included in other parts of the ISO 11608 series.

Infusion pumps that are designed for continuous delivery at a specific rate required to achieve and/or maintain a desired plasma medicinal product concentration are excluded from this document. However, while this document is not intended to directly apply to these pump products, it does contain requirements and test methods that can be used to help design and evaluate them.

NOTE 3 They are covered by IEC 60601‑2‑24 (if electronic) or ISO 28620 (if non-electronic).

2 Normative references

3 Terms and definitions

4 Requirements

4.1 General

4.2 Risk assessment

4.3 Usability engineering

4.4 Uncertainty of measurement and conformance with specifications

4.5 General design requirements

4.6 Physical or mechanical requirements and test methods

4.7 Functional performance requirements and test methods

4.8 Biological requirements of the OBDS

4.9 Medicinal product compatibility

4.10 Electrical safety and software requirements

5 Inspection

6 Information supplied by the manufacturer

Bibliography

BS ISO 11608-6:2022

Needle-based injection systems for medical use. Requirements and test methods - On-body delivery systems

Current

Published:

30 Apr 2022