oSIST prEN ISO 11608-5:2023

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)

Dieses Dokument legt Anforderungen an und Prüfverfahren für automatisierte Funktionen in kanülenbasierten Injektionssystemen mit automatisierten Funktionen (NIS AUTOs) fest.
Für alle automatisierten Funktionen werden allgemeine Anforderungen bereitgestellt. Darüber hinaus werden spezifische allgemeine Anforderungen für die folgenden automatisierten Funktionen bereitgestellt:
a)   Arzneimittelzubereitung (z. B. Rekonstitution);
b)   Vorbereitung der Kanüle;
c)   Kanülenverdeckung;
d)   Betriebsbereitmachen;
e)   Einstellen der Dosis;
f)   Einführen der Kanüle;
g)   Steuerung der Injektionstiefe;
h)   Injizieren des Arzneimittels;
i)   Aufzeichnung der Gerätefunktionen;
ANMERKUNG   Dieses Dokument behandelt keine Fernkommunikationsfunktionen von NIS AUTOs (bezieht sich auf die drahtgebundene und drahtlose Kommunikationsübertragung von dem NIS AUTO).
j)   Deaktivieren des NIS AUTO;
k)   Einziehen der Kanüle;
l)   Abschirmung der Kanüle;
m)   Entfernen der Kanüle.
Alle Verweisungen auf „Funktion“ in diesem Dokument werden laut Definition als automatisierte Funktion ausgelegt (siehe 3.2). Dieses Dokument ist nicht anwendbar für Funktionen, die vom Benutzer manuell ausgeführt werden.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO 11608-5:2022)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del: Avtomatizirane funkcije (ISO 11608-5:2022)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Jan-2023
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 01-Dec-2022
• Due Date: 20-Apr-2023
• Completion Date: 15-Feb-2023
• Ref Project: EN ISO 11608-5:2023 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

Relations

• Revised: SIST EN ISO 11608-5:2013 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
• Effective Date: 05-Oct-2022
• Revised: SIST EN ISO 11608-5:2013 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
• Effective Date: 18-Jan-2023
• Revised: SIST EN ISO 11608-5:2013 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 11608-5:2023
01-januar-2023

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del:

Avtomatizirane funkcije (ISO 11608-5:2022)

Needle-based injection systems for medical use - Requirements and test methods - Part

5: Automated functions (ISO 11608-5:2022)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und

Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -

Partie 5: Fonctions automatisées (ISO 11608-5:2022)
Ta slovenski standard je istoveten z: prEN ISO 11608-5
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 11608-5:2023 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11608-5:2023
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oSIST prEN ISO 11608-5:2023
INTERNATIONAL ISO
STANDARD 11608-5
Second edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 5:
Automated functions
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d'essai —
Partie 5: Fonctions automatisées
Reference number
ISO 11608-5:2022(E)
© ISO 2022
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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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 on

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 2

4 Requirements .......................................................................................................................................................................................................... 4

4.1 General requirements ...................................................................................................................................................................... 4

4.2 Medicinal product preparation ................................................................................................................................................ 5

4.3 Needle preparation ............................................................................................................................................................................. 6

4.4 Needle hiding ........................................................................................................................................................................................... 6

4.5 Priming .......................................................................................................................................................................................................... 6

4.6 Dose setting ............................................................................................................................................................................................... 6

4.7 Needle insertion .................................................................................................................................................................................... 6

4.8 Injection depth control .................................................................................................................................................................... 6

4.9 Dose delivery ............................................................................................................................................................................................ 7

4.10 Recording of device functions .................................................................................................................................................. 7

4.11 Needle retraction ................................................................................................................................................................................. 7

4.11.1 Completion of dose delivery ..................................................................................................................................... 7

4.11.2 Needle retraction distance ........................................................................................................................................ 7

4.11.3 Communication of completion ............................................................................................................................... 7

4.12 Disabling the NIS-AUTO.................................................................................................................................................................. 7

4.13 Needle shielding .................................................................................................................................................................................... 8

4.13.1 General ........................................................................................................................................................................................ 8

4.13.2 Needle shielding before injection ........................................................................................................................ 8

4.13.3 Needle shielding after injection ............................................................................................................................ 8

4.14 Needle removal from the NIS-AUTO ................................................................................................................................... 8

5 Test methods ............................................................................................................................................................................................................ 8

5.1 General ........................................................................................................................................................................................................... 8

5.2 Test conditions ........................................................................................................................................................................................ 9

5.3 Actuation ..................................................................................................................................................................................................... 9

5.4 Medicinal product preparation ................................................................................................................................................ 9

5.5 Needle inspection ................................................................................................................................................................................ 9

5.6 Needle hiding ........................................................................................................................................................................................... 9

5.7 Priming ....................................................................................................................................................................................................... 10

5.8 Needle extension ............................................................................................................................................................................... 10

5.9 Injection time ........................................................................................................................................................................................ 10

5.10 Dose accuracy ....................................................................................................................................................................................... 11

5.11 Retracted position ............................................................................................................................................................................ 11

5.12 Disabling the NIS-AUTO............................................................................................................................................................... 11

5.13 Needle shielding ................................................................................................................................................................................. 11

5.13.1 Needle shielding before and after injection ............................................................................................ 11

5.13.2 Needle shielding after free fall............................................................................................................................ 11

6 Information supplied with the NIS-AUTO ..............................................................................................................................11

Annex A (informative) Rationale for requirements .........................................................................................................................12

Annex B (informative) Example of a test method for dose accuracy at intended injection

depth ..............................................................................................................................................................................................................................14

Annex C (informative) Needle extension and intended injection depth ....................................................................16

Bibliography .............................................................................................................................................................................................................................22

iii
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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)
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.

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

technically revised.
The main changes 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.
© ISO 2022 – All rights reserved
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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)
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.
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oSIST prEN ISO 11608-5:2023
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oSIST prEN ISO 11608-5:2023
INTERNATIONAL STANDARD ISO 11608-5:2022(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 5:
Automated functions
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:
a) medicinal product preparation (e.g. reconstitution);
b) needle preparation;
c) needle hiding;
d) priming;
e) dose setting;
f) needle insertion;
g) injection depth control;
h) injection of the medicinal product;
i) 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).
j) disabling the NIS-AUTO;
k) needle retraction;
l) needle shielding;
m) 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

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 11608-1:2022, Needle-based injection systems for medical use — Requirements and test methods —

Part 1: Needle-based injection systems
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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)

ISO 11608-3:2022, Needle-based injection systems for medical use — Requirements and test methods —

Part 3: Containers and integrated fluid paths

ISO 23908:2011, Sharps injury protection — Requirements and test methods — Sharps protection features

for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 11608-1 and the following

apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
actuation
user action that initiates an automated function

EXAMPLE Needle insertion (3.13). Pressing the needle-based injection system with automated function (3.18)

against the injection site.
3.2
automated function
function that does not require user interaction after actuation (3.1)
Note 1 to entry: Dose counting.
3.3
disabling

function that changes the state of the needle-based injection system with automated function (NIS-AUTO)

(3.18) such that it is not able to be refilled, reloaded, reset, or reactivated for dose delivery, which will

allow the NIS-AUTO to perform any subsequent injections (including single-dose and the last dose of

multi-dose NIS-AUTOs)
3.4
dose setting
function that sets the dose to be delivered
3.5
injection depth control

function or feature that controls the needle extension (3.11) such that the medicinal product is delivered

at the intended injection depth (3.8)
3.6
injection of medicinal product
function that delivers the dose
3.7
injection time

time from initiation to completion of the injection of medicinal product (3.6) as described in the

instructions for use

Note 1 to entry: The injection time that might be indicated in the instructions for use (IFU, sometime called hold

time) can be the same or greater than the measured injection time, based on use risk approach.

Note 2 to entry: There can be a delay from actuation to initiation of injection that might be indicated in the IFU

which might be measured and verified separately as determined by risk approach.
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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)
3.8
intended injection depth

range of distance from the skin surface to the point at which the medicinal product is intended to be

delivered
Note 1 to entry: See Figures in Annex C.
3.9
medicinal product preparation
function that prepares the medicinal product for administration
EXAMPLE Reconstitution, filling of reservoir.
3.10
needle cover

cover provided over a needle in order to protect the needle from damage and users from unintended

needle sticks prior to use

Note 1 to entry: A needle cover alone is not a sharps injury protection feature unless it conforms to ISO 23908.

3.11
needle extension

distance from the patient end of the needle tip to the nearest part of the needle-based injection system

with automated function (3.18) body

Note 1 to entry: The nearest part of the needle-based injection system with automated function body is the point

of contact with the patient adjacent to the injection site.
Note 2 to entry: See Annex C for more details.
3.12
needle hiding

function that intentionally obscures the needle from the user's sight before, during and/or after the

injection cycle
3.13
needle insertion

function that inserts the needle into the injection site to the intended injection depth (3.8) prior to the

injection of the medicinal product (3.6)
3.14
needle preparation
function that prepares the needle for use
Note 1 to entry: Needle attachment, removal of needle cover (3.10).
3.15
needle removal

function that disconnects the needle from the needle-based injection system with automated function

(3.18) fluid path
3.16
needle retraction

function that removes the needle from the target tissue to a predefined position inside the needle-based

injection system with automated function (3.18)
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ISO 11608-5:2022(E)
3.17
needle shielding

function that covers the needle before and/or after the injection cycle to reduce the likelihood of direct

contact with the needle

Note 1 to entry: Needle shielding alone is not a sharps injury protection feature unless it conforms with

ISO 23908.
3.18
needle-based injection system with automated function
NIS-AUTO

injection system that delivers a medicinal product through a needle wherein one or a series of functions

are initiated by an action of the user and controlled automatically by the injection system

Note 1 to entry: A manual needle-based injection system with accessories that perform automatic functions are

regarded as NIS-AUTO.
3.19
persistent visual indication

visual indication that remains in place until the state of the needle-based injection system changes or

until the end of the needle-based injection system use-life
3.20
recording
function that records information
EXAMPLE Dose counter.

Note 1 to entry: A needle-based injection system with automated function (3.18) might include several different,

possibly related, recording functions, which record different pieces of information related to the dose

administered.
4 Requirements
4.1 General requirements

a) Automated functions shall be verified in accordance with the design verification approach in

ISO 11608-1, including sampling plan and data analysis, applying the requirements and test

methods in this document.

b) Where the completion of an automated function is intended to be communicated to the user,

the needle-based injection system (NIS) shall indicate by visual, audible or tactile means, or any

combination of these that the function has been completed unless otherwise specified in this

document. These means should be appropriate to the intended use of the NIS.

c) Users shall be able to clearly distinguish between a NIS-AUTO that is unused, in use, used or

disabled or requiring another user action such as a "setup" step before it can be used again. For

automated functions that change the state of the NIS-AUTO, a persistent visual indication of the

NIS-AUTO state shall be provided (e.g. ready for use, in use, disabled or other states relevant for the

particular NIS-AUTO).

d) Where the design of a NIS-AUTO allows manual operations to be performed in a sequence other

than that specified in the instructions for use, the risk assessment shall address the risks of out-of-

sequence operation.
e) Actuation of each automated function shall meet the following requirements:

1) Actuation of injection: A minimum of two manual actions shall be required in order to initiate

injection, e.g. from locked to unlocked state/ready for injection, then press to actuate. A

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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)

multi-dose/use injection system with automated functions, once actuated, shall not allow an

additional actuation without a separate and distinct action prior to a subsequent actuation.

2) Actuation shall be tested in accordance with 5.3.

f) Automated functions shall not compromise the primary functions of the NIS-AUTO.

g) For each automated function included within the NIS-AUTO design, testing in accordance with

Clause 5 shall be performed. If the function is not included or is not automated within the design,

the relevant requirements of Clause 4 do not apply and testing in accordance with Clause 5 shall

not be performed. Table 1 provides a matrix of the specific requirements and test methods for each

automated function.

h) Where requirements in this document provide a test method without acceptance criteria, a

specification and acceptance criteria shall be established for the automated function appropriate

to the intended use of the NIS-AUTO and using a risk-based approach.

i) Where this document does not provide requirements and/or a test method, there shall be

established a specification, acceptance criteria, and a method of verifying the automated function

appropriate to the intended use of the NIS-AUTO and using a risk-based approach.
Table 1 — Requirements and test methods for automated functions
Automated function Requirement Test method

Medicinal product preparation 4.2 Medicinal product preparation 5.4 Medicinal product preparation

Needle preparation 4.3 Needle preparation 5.5 Needle inspection
Needle hiding 4.4 Needle hiding 5.6 Needle hiding
Priming 4.5 Priming 5.7 Priming
Dose setting 4.6 Dose setting Use the risk-based approach as
specified in 4.1 i)
Needle insertion 4.7 Needle insertion 5.5 Needle inspection
Injection depth control 4.8 Injection depth control 5.8 Needle extension
Injection of the medicinal product 4.9 Dose delivery 5.10 Dose accuracy
5.9 Injection time
4.8 Injection depth control

Recording of device functions 4.10 Device function information Use the risk-based approach as

specified in 4.1 i)
Disabling 4.12 Disabling the NIS-AUTO 5.12 Disabling the NIS-AUTO
Needle retraction 4.11 Needle retraction 5.10 Dose accuracy
5.11 Retracted position
Needle shielding 4.13 Needle shielding 5.13 Needle shielding
Needle removal 4.14 Needle removal from the Use the risk-based approach as
NIS-AUTO specified in 4.1 i)
NOTE Statistical requirements are specified in ISO 11608-1.
4.2 Medicinal product preparation

Automated medicinal product preparation shall not compromise the medicinal product. The NIS-AUTO

shall indicate to the user that the automated medicinal product preparation has been completed by at

least visual means.

If risk assessment determines that it is necessary for the user to confirm that the medicinal product has

been properly prepared, then the NIS-AUTO shall:
a) allow the user to perform visual inspection of the medicinal product; and/or
b) provide feedback that the medicinal product has been properly prepared.
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oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)
Medicinal product preparation shall be tested in accordance with 5.4.
4.3 Needle preparation

The needle shall not be damaged by the automated function (needle attachment, removal of needle

cover, etc.). If any portion of the needle preparation is an automated function and involves piercing of

an elastomeric component the NIS-AUTO shall meet the requirements for coring in accordance with

ISO 11608-3:2022, 4.2.3. The NIS-AUTO shall indicate to the user that the automated needle preparation

has been completed by at least visual means.

After needle preparation there shall be no obvious damage to the needle (e.g. kinked or bent lumen)

and the patient end needle point (e.g. free from feather edges, burrs and hooks).

Needle preparation shall be tested in accordance with 5.5.
4.4 Needle hiding

If automated needle hiding is applicable before, during or after injection, the needle shall not be visible

when the NIS-AUTO is placed against the injection site, when tested in accordance with 5.6.

Post-injection needle hiding shall not be considered to be needle shielding.

NOTE The needle hiding function only has a visual requirement. It is not subject to any physical or

dimensional requirements intended to restrict access to the needle. It does not imply any increased level of safety

from needle stick injuries.
4.5 Priming

Dose accuracy testing shall be performed once priming is complete. The NIS-AUTO shall indicate to the

user that the automated priming has been completed by at least visual means.
Priming shall be tested in accordance with 5.7.
4.6 Dose setting

Following automated dose setting the NIS-AUTO shall provide an indication that the dose has been set

by at least visual means.

It shall be verified that the input(s) to the automatic dose setting function result in the intended set

dose.

A test method shall be specified applying the risk-based approach specified in 4.1 i).

4.7 Needle insertion

The needle shall not be damaged by the automated feature, when tested in accordance with 5.5.

NOTE See requirement 4.3 for examples of needle point damage.
4.8 Injection depth control

When the design is such that the user does not have control over the depth to which the needle is

inserted, the insertion depth shall be within the intended insertion limits specified, when tested in

accordance with 5.8.
NOTE See Annex C for more details.
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4.9 Dose delivery
The dose accurac
...