Foreword

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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).

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This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and catheters, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition ( ISO 11608-5:2012 ), which has been technically revised.

The main changes compared to the previous edition are as follows:

This document has been clarified to explain that an automated function is one which does not require user interaction after the action which initiates the function, including designating injection depth control as automated when the user does not have control over the depth to which the needle is inserted, even where needle insertion is performed manually.

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

This document is applicable to needle-based injection systems (NIS) with automated functions (NIS-AUTO) primarily intended to administer medicinal products to humans. In order to support device innovation and design, this document has been written in a format that describes the output of the design effort rather than prescribing the exact form of construction of the NIS-AUTO This document should be used in conjunction with ISO 11608-1 .

1 Scope

This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).

General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:

medicinal product preparation (e.g. reconstitution);
needle preparation;
needle hiding;
priming;
dose setting;
needle insertion;
injection depth control;
injection of the medicinal product;
recording of device functions;
NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto).
disabling the NIS-AUTO;
needle retraction;
needle shielding;
needle removal.

All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.

2 Normative references

3 Terms and definitions

4 Requirements

4.1 General requirements

4.2 Medicinal product preparation

4.3 Needle preparation

4.4 Needle hiding

4.5 Priming

4.6 Dose setting

4.7 Needle insertion

4.8 Injection depth control

4.9 Dose delivery

4.10 Recording of device functions

4.11 Needle retraction

4.12 Disabling the NIS-AUTO

4.13 Needle shielding

4.14 Needle removal from the NIS-AUTO

5 Test methods

5.1 General

5.2 Test conditions

5.3 Actuation

5.4 Medicinal product preparation

5.5 Needle inspection

5.6 Needle hiding

5.7 Priming

5.8 Needle extension

5.9 Injection time

5.10 Dose accuracy

5.11 Retracted position

5.12 Disabling the NIS-AUTO

5.13 Needle shielding

6 Information supplied with the NIS-AUTO

Bibliography

ISO 11608-5:2022

Needle-based injection systems for medical use - Requirements and test methods - - Part 5: Automated functions

Current

Published:

7 Apr 2022