Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/DIS 11608-5:2020)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO/DIS 11608-5:2020)

Dieses Dokument legt Anforderungen an und Prüfverfahren für kanülenbasierte Injektionssysteme mit automatisierten Funktionen (NIS AUTOs) fest, die Folgendes umfassen, jedoch nicht allein darauf beschränkt sind:
a)   Arzneimittelzubereitung (z. B. Rekonstitution);
b)   Vorbereitung der Kanüle;
c)   Verdeckung (Sichtschutz) der Injektionskanüle;
d)   Betriebsbereitmachen;
e)   Einstellen der Dosis;
f)   Einführen der Kanüle;
g)   Steuerung der Injektionstiefe;
h)   Injizieren des Arzneimittels;
i)   Aufzeichnung;
j)   Deaktivieren des NIS AUTO;
k)   Einziehen der Kanüle;
l)   Schutzschild der Kanüle;
m)   Entfernen der Kanüle.
Dieses Dokument behandelt keine Fernkommunikationsfunktionen von NIS AUTOs.
Automatisierte Funktionen, die nicht in der obigen Liste aufgeführt sind, müssen nach den in diesem Dokument dargestellten Grundsätzen spezifiziert und geprüft werden.
Alle Verweisungen auf „Funktion“ in diesem Dokument sind laut Definition als automatisierte Funktion auszulegen (siehe 3.2). Dieses Dokument gilt nicht für diese Funktionen, wenn sie durch den Benutzer manuell ausgeführt werden.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO/DIS 11608-5:2020)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del: Avtomatizirane funkcije (ISO/DIS 11608-5:2020)

General Information

Status
Not Published
Current Stage
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Due Date
11-Jun-2021
Completion Date
11-Jun-2021

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SLOVENSKI STANDARD
oSIST prEN ISO 11608-5:2020
01-april-2020

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

Avtomatizirane funkcije (ISO/DIS 11608-5:2020)

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

5: Automated functions (ISO/DIS 11608-5:2020)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und

Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO/DIS 11608-5:2020)

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

Partie 5: Fonctions automatisées (ISO/DIS 11608-5:2020)
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 11608-5:2020 en

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

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oSIST prEN ISO 11608-5:2020
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oSIST prEN ISO 11608-5:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-5
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2020-02-18 2020-05-12
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
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11608-5:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 11608-5:2020
ISO/DIS 11608-5:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

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
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Phone: +41 22 749 01 11
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 11608-5:2020
ISO/DIS 11608-5:2020(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 ............................................................................................................................................................................. 5

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 ............................................................................................................................................................................................ 6

4.10 Device function information........................................................................................................................................................ 6

4.11 Needle retraction .................................................................................................................................................................................. 6

4.11.1 Completion of dose delivery .................................................................................................................................. 6

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 .................................................................................................................................................................................... 7

4.13.1 General...................................................................................................................................................................................... 7

4.13.2 Needle shielding before injection ...................................................................................................................... 7

4.13.3 Needle shielding after injection .......................................................................................................................... 7

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

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

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

5.2 Test conditions ........................................................................................................................................................................................ 8

5.3 Actuation ...................................................................................................................................................................................................... 8

5.4 Medicinal product preparation ................................................................................................................................................. 8

5.5 Needle inspection ................................................................................................................................................................................. 8

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

5.7 Priming .......................................................................................................................................................................................................... 9

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

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

5.10 Dose accuracy .......................................................................................................................................................................................10

5.11 Retracted position .............................................................................................................................................................................10

5.12 Disabling the NIS-AUTO ...............................................................................................................................................................10

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 to be supplied by the manufacturer ............................................................................................................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 .............................................................................................................................................................................................................................21

© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 11608-5:2020
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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 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 the following URL: www .iso .org/ iso/ foreword .html.

This document was prepared by 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.

Information about the revision history of the ISO 11608 series can be found in ISO 11608-1:20##.

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 © ISO 2020 – All rights reserved
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Introduction

This document is applicable to needle-based injection systems (NIS) with automated functions (NIS-

AUTO) primarily intended to administer medicinal products to humans. Because of the anticipated

variation in the designs of NIS-AUTOs, it tends to specify the results of the design effort instead of the

physical and construction requirements used as the basis for NIS-AUTO design, so that innovation in

achieving the intended purposes is not unnecessarily restricted. As such, this document intends to

address basic elements regarding the safety and performance of NIS-AUTOs.

Despite certain advantages for intentional interchangeability for containers designed for different auto-

injection systems, as well as the potential risks of inadvertent interchangeability, this document avoids

setting forth design specifications for the uniform size, shape and interface of such containers. It is left

for future initiatives to build upon the specifications in this document.

ISO 11608-1 is the umbrella document of the ISO 11608 series. All other parts, including this document,

are to be used in conjunction with ISO 11608-1.

Guidance on transition periods for implementing the requirements of this document is given in

ISO/TR 19244.
© ISO 2020 – All rights reserved v
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oSIST prEN ISO 11608-5:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 11608-5:2020(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 needle-based injection systems with

automated functions (NIS-AUTO), including but not limited to:
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;
j) disabling the NIS-AUTO;
k) needle retraction;
l) needle shielding;
m) needle removal.
This document does not cover remote communication from the NIS-AUTO.

Automated features not included in the list above shall be specified and tested in accordance with the

principles of this document.

All references to "function" in this document are by definition to be construed as automated functions

(see 3.2). This document does not apply to these functions if they 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 , Needle-based injection systems for medical use — Requirements and test methods — Part 1:

Needle-based injection systems

1) To be published (revises ISO 11608-1:2012). Stage at time of publication: ISO/DIS 11608-1:2020.

© ISO 2020 – All rights reserved 1
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oSIST prEN ISO 11608-5:2020
ISO/DIS 11608-5:2020(E)

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 terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
actuation

action which initiates a NIS-AUTO function (e.g. needle insertion (3.14)), carried out by the NIS-AUTO

user (or by another automated function (3.2))
EXAMPLE Pressing the NIS-AUTO (3.9) against the injection site.
3.2
automated function
function which does not require user interaction after actuation (3.1)

Note 1 to entry: A dose counter is considered an automated function if it changes its state without any user

interaction.
3.3
disabling

function that changes the state of the NIS-AUTO (3.9) such that it is not able to be refilled, reloaded,

reset, or reactivated for dose delivery, which will allow the NIS-AUTO (3.9) to perform any subsequent

injections (including single-dose and the last dose of multi-dose systems)
3.4
dose setting (and memory)

function which sets the dose to be delivered (dose setting) and/or displays the previously set dose

(memory)
3.5
injection of medicinal product
function which delivers the dose
3.6
injection time

time from actuation (3.1) to completion of the injection of medicinal product (3.5) as described in the IFU

3.7
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.
3.8
medicinal product preparation

function which prepares the medicinal product for administration (e.g. reconstitution)

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3.9
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: Accessories that perform automatic functions in combination with manual injection NIS-AUTOs

are regarded as NIS-AUTO.
3.10
needle cover

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

prior to use

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

3.11
injection depth control

function which controls the needle extension (3.12) such that the medicinal product is delivered at the

intended injection depth (3.7)
3.12
needle extension

axial distance from the patient end of the needle tip to the nearest part of the NIS-AUTO body (defining

the point of contact with the patient adjacent to the injection site)
3.13
needle hiding

function which intentionally obscures the needle from the user's sight either before, during or after the

injection cycle

Note 1 to entry: 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.
3.14
needle insertion

function which inserts the needle into the injection site to the intended injection depth (3.7) prior to the

injection of the medicinal product
3.15
needle preparation

function which prepares the needle for use (e.g. needle attachment, removal of needle cover (3.10), etc.)

Note 1 to entry: The needle preparation function may be a feature of the design and not a mechanical action.

For example, a NIS cap may contain features that interact with the needle cover (3.10) and when the NIS cap is

removed, the needle cover (3.10) is automatically removed.
3.16
needle removal
function which disconnects the needle from the NIS-AUTO fluid path
3.17
needle retraction

function which removes the needle from the target tissue to a predefined position inside the NIS-

AUTO (3.9)
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3.18
needle shielding

function which 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 complies with ISO 23908.

3.19
priming

function that makes the dosing mechanism of the NIS-AUTO (3.9) ready for dose administration (e.g.

removing the air from the fluid path)

Note 1 to entry: Needle preparation (3.15) and fluid path connection should be considered separately.

3.20
recording
function which records information (e.g. dose counter)

Note 1 to entry: A NIS-AUTO (3.19) may 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) Any automated function considered a primary function shall be verified in accordance with

ISO 11608-1.

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

be apparent by visual means; and either tactile or audible means (i.e. visual and tactile, visual and

audible) unless otherwise specified in this document.

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

disabled or requiring another "setup" step before it can be used again. For automated functions

that change the state of the NIS-AUTO, a 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

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 interfere with the primary functions of the NIS-AUTO.

g) For each automated function included within the NIS-AUTO design, the manufacturer shall apply

the applicable requirements in this paragraph and perform testing in accordance with Clause 5.

Where the design does not include the automated function, or does not automate the function,

the relevant requirements of Clause 4 do not apply, and testing in accordance with the sections of

Clause 5 is not needed. Refer to Table 1 for a matrix of the specific requirements and test methods

for each automated function.
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Table 1 — Requirements and test methods for automated functions (Ref. 4.1)
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 Per risk assessment
Needle insertion 4.7 Needle insertion 5.5 Needle inspection
Needle extension control 4.8 Injection depth control 5.8 Needle extension
Inject medicinal product 4.9 Dose delivery 5.10 Dose accuracy
5.9 Injection time
Recording 4.10 Device function information Per risk assessment
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 Test method references included in
NIS-AUTO requirement
NOTE Statistical requirements are specified in ISO 11608-1.
4.2 Medicinal product preparation

Automated medicinal preparation shall not have an adverse impact on 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.
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 11608-3:20##, 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 and the patient end needle

point shall appear sharp and free from feather edges, burrs and hooks.
Needle preparation shall be tested in accordance with 5.5.
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4.4 Needle hiding

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

when the device is placed against the injection site, when tested in accordance with 5.6.

NOTE Post-injection needle hiding is not considered to be needle shielding. 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.

4.7 Needle insertion

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

4.8 Injection depth control

When the user does not have control over the depth to which the needle is inserted, the depth at which

the medicinal product is delivered shall be confirmed by measuring the needle extension according to 5.8.

NOTE See Annex C for more details.
4.9 Dose delivery
The dose accuracy shall be confirmed according to 5.10.

The dose delivery shall be completed within the specified injection time, as determined through

...

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