Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)

ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.

Kanülenbasierte Injektionssysteme zur medizinischen Anwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012)

Dieser Teil der ISO 11608 legt Anforderungen an und Prüfverfahren für die automatisierten Funktionen von kanülenbasierten Injektionssystemen mit automatisierten Funktionen (NIS AUTO) zur Verabreichung von Arzneimitteln an Menschen fest, die Folgendes umfassen, jedoch nicht allein darauf beschränkt sind:
a)   Arzneimittelzubereitung (z. B. Rekonstitution);
b)   Vorbereitung der Kanüle;
c)   Entlüftung;
d)   Betriebsbereitmachen;
e)   Einstellen der Dosis;
f)   Betätigung;
g)   Einführen der Kanüle;
h)   Injizieren des Arzneimittels;
i)   Deaktivieren des NIS AUTOs;
j)   Einziehen der Kanüle;
k)   Schutzschild der Kanüle;
l)   Verdeckung (Sichtschutz) der Injektionskanüle;
m)   Schutz vor Schnitt  und Stichverletzungen;
n)   Entfernen der Kanüle.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO 11608-5:2012)

L'ISO 11608-5:2012 spécifie les exigences et méthodes d'essai pour les fonctions automatisées des systèmes d'injection à aiguille dotés de fonctions automatisées (NIS‑AUTO) pour l'administration de produits médicaux chez l'homme.

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del: Avtomatizirane funkcije (ISO 11608-5:2012)

Ta del standarda ISO 11608 določa zahteve in poskusne metode za avtomatizirane funkcije peres za injiciranje z avtomatiziranimi funkcijami (NIS-AUTO), ki so namenjene upravljanju z zdravstvenimi izdelki pri ljudeh in med drugim vključujejo tudi:
a) pripravo zdravil (npr. obnova);
b) pripravo igel;
c) odstranitev zraka;
d) vbrizgavanje;
e) priprava odmerka;
f) odmerjanje;
g) vstavljanje igle;
h) vbrizg zdravstvenega izdelka;
i) onemogočanje peresa za injiciranje z avtomatiziranimi funkcijami;
j) izvlečenje igle;
k) zaščito igle;
l) prikrivanje igle;
m) zaščito pred poškodbami zaradi ostrih predmetov;
n) odstranitev igle.

General Information

Status
Published
Publication Date
30-Sep-2012
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
01-Oct-2012
Completion Date
01-Oct-2012

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SLOVENSKI STANDARD
SIST EN ISO 11608-5:2013
01-januar-2013

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

Avtomatizirane funkcije (ISO 11608-5:2012)

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

5: Automated functions (ISO 11608-5:2012)
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012)

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

Partie 5: Fonctions automatisées (ISO 11608-5:2012)
Ta slovenski standard je istoveten z: EN ISO 11608-5:2012
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-5:2013 en

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

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SIST EN ISO 11608-5:2013
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SIST EN ISO 11608-5:2013
EUROPEAN STANDARD
EN ISO 11608-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 11.040.25
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 5: Automated functions (ISO 11608-
5:2012)

Systèmes d'injection à aiguille pour usage médical - Nadelbasierte Injektionssysteme zur medizinischen

Exigences et méthodes d'essai - Partie 5: Fonctions Verwendung - Anforderungen und Prüfverfahren - Teil 5:

automatisées (ISO 11608-5:2012) Automatisierte Funktionen (ISO 11608-5:2012)
This European Standard was approved by CEN on 29 September 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same

status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United

Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-5:2012: E

worldwide for CEN national Members.
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SIST EN ISO 11608-5:2013
EN ISO 11608-5:2012 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC ............................................................................................4

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SIST EN ISO 11608-5:2013
EN ISO 11608-5:2012 (E)
Foreword

This document (EN ISO 11608-5:2012) has been prepared by Technical Committee ISO/TC 84 "Devices for

administration of medicinal products and intravascular catheters" in collaboration with Technical Committee

CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical

text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the

latest by April 2013.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive.

For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following

countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech

Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 11608-5:2012 has been approved by CEN as a EN ISO 11608-5:2012 without any

modification.
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SIST EN ISO 11608-5:2013
EN ISO 11608-5:2012 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide a means of conforming to Essential Requirements of the

New Approach Directive 93/42/EEC on Medical Devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been

implemented as a national standard in at least one Member State, compliance with the clauses of this

standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of

conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

on medical devices

Clause(s)/subclause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes

European Standard Directive 93/42/EEC
Clauses 4.1 to 4.3, all parts 1 Clause 10, all parts of ISO 11608-1
addresses pre-conditioning
Clauses 4.1 to 4.4, all parts 2 Clause 10, all parts of ISO 11608-1
addresses pre-conditioning
Clauses 4.1 to 4.3, 5, 6, all parts 3 All clauses of ISO 11608-1 are
applicable
NA 4
NA 5
Clause 4.1 parts E and G, clause 6
4.3 all parts
Clauses 4.2.2 and 5.1.1 7 Only 7.3 is addressed
Clause 4.1 parts D 8 Only 8.3 is addressed
Clauses 4.1 to 4.4, all parts 9 9.3 is not addressed
Clause 10, all parts of ISO 11608-1
addresses pre-conditioning
Clauses 4.2.5, 4.3.3.3, 4.3.5.1, 10 All clauses of ISO 11608-1 are
5.1.4, 5.1.7, 5.1.8.1 and 5.2 applicable
NA 11
NA 12
Clause 7 13 13.5 is not addressed
Clause 5.4, part D and Q and
Clause 13, all parts of ISO 11608-1
address ER 13

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this standard.
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SIST EN ISO 11608-5:2013
INTERNATIONAL ISO
STANDARD 11608-5
First edition
2012-10-01
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 11608-5:2012(E)
ISO 2012
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s

member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
Contents Page

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

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

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

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

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

4 Requirements ....................................................................................................................................................... 3

4.1 General requirements ......................................................................................................................................... 3

4.2 Preparation ............................................................................................................................................................ 4

4.3 Injection ................................................................................................................................................................. 5

4.4 Risk analysis requirements .............................................................................................................................. 8

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

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

5.2 Dose specification requirements .................................................................................................................. 11

5.3 Uncertainty of measurements and conformance with specifications ................................................12

6 Test report ...........................................................................................................................................................12

7 Information to be supplied by the manufacturer ......................................................................................12

Annex A (informative) Rationale for requirements ..................................................................................................13

Bibliography .....................................................................................................................................................................15

© ISO 2012 – All rights reserved iii
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 11608-5 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal

products and intravascular catheters.

ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical

use — Requirements and test methods:
— Part 1: Needle-based injection systems
— Part 2: Needles
— Part 3: Finished containers

— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

— Part 5: Automated functions
iv © ISO 2012 – All rights reserved
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
Introduction

This part of ISO 11608 is applicable to needle-based injection systems with automated functions (NIS-

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

in the designs of NIS-AUTOs, this part of ISO 11608 is promulgated more as a “horizontal” than a “vertical”

standard. Thus, 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.

This part of ISO 11608 intentionally avoids addressing more than the most basic elements regarding the safety

and performance of NIS-AUTOs in humans. Any intended labelling of such NIS-AUTOs indicating their use to

deliver medicinal products into the body or into specified tissue strata thereof (e.g. intramuscular, subcutaneous

or intradermal), or for the administration of specific pharmaceutical drugs or vaccines, falls under the authority

of national governments or supranational agencies regulating the manufacture and marketing of medical NIS-

AUTOs and pharmaceutical products.

This part of ISO 11608 is expected to be supplemented by additional requirements and might occasionally

be superseded by such regulatory authorities. Despite certain advantages for intentional interchangeability

for containers designed for different auto-injection systems, as well as the potential risks of inadvertent

interchangeability, this part of ISO 11608 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 part of ISO 11608.

The sampling plans for inspection selected for this part of ISO 11608 are intended to verify the design, at a high

confidence level. The sampling plan does not replace more general manufacturing quality systems, including

lot release, which are addressed in standards on quality management systems, for example the ISO 9000

series or ISO 13485.

All references to “function” in this part of ISO 11608 are by definition to be construed as automated functions

(see 3.4). This part of ISO 11608 does not apply to these functions if they are performed manually by the user.

© ISO 2012 – All rights reserved v
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SIST EN ISO 11608-5:2013
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SIST EN ISO 11608-5:2013
INTERNATIONAL STANDARD ISO 11608-5:2012(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 5:
Automated functions
1 Scope

This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based

injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans,

including but not limited to:
a) drug product preparation (e.g. reconstitution);
b) needle preparation;
c) air removal;
d) priming;
e) dose setting;
f) actuation;
g) needle insertion;
h) injection of the medicinal product;
i) disabling the NIS-AUTO;
j) needle retraction;
k) needle shielding;
l) needle hiding;
m) sharps injury protection;
n) needle removal.
2 Normative references

The following referenced documents are indispensable for the application 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
ISO 14971, Medical devices — Application of risk management to medical devices

IEC 62366, Medical devices — Application of usability engineering to medical devices

© ISO 2012 – All rights reserved 1
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accessory

article or supplementary part used for convenience or safety in conjunction with a NIS-AUTO

EXAMPLES Magnifying lens to aid reading of dose setting, grip enhancer, dose counter of a NIS-AUTO.

3.2
actuation

action which initiates a NIS-AUTO function (e.g. needle insertion), triggered by the actions of the NIS-AUTO

user (or by another automated function)
EXAMPLE Pressing the NIS-AUTO against the injection site.
3.3
air removal
action to remove air from the container and/or needle of the NIS-AUTO
3.4
automated function
function which does not require user initiation after actuation

NOTE A dose counter is considered an automated function if it is initiated by, for example, an automated needle

retraction step, and therefore changes its state without any user interference.
3.5
injection
delivery of the dose to the intended injection depth
3.6
intended injection depth
range of injection depth to which the drug is intended to be delivered
See Figure 1.
3.7
needle-based injection system with automated functions
NIS-AUTO

injection system that delivers a medication 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 Accessories that perform automatic functions in combination with manual injection NIS-AUTOs are

regarded as NIS-AUTO.
3.8
needle cover

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

of the needle
3.9
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)
2 © ISO 2012 – All rights reserved
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
3.10
needle hiding

function which obscures the needle from the user’s sight either before, during or after the injection cycle

NOTE The needle hiding function only has a visual requirement designed to reduce patient trauma in case of needle

phobia. 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.
3.11
insertion of needle

function which inserts the needle into the patient’s skin to the intended injection depth prior to the injection of

the medicinal product
3.12
needle shielding

function which covers the exposed needle before and/or after the injection cycle to reduce the likelihood of

direct contact with the needle

NOTE 1 Needle shielding can reduce the risk of damage and contamination of the needle before use and can cover the

needle after use.

NOTE 2 Needle shielding does not meet the requirements of a sharps injury protection feature unless it complies

with ISO 23908.
3.13
priming
function that makes the dosing mechanism of the NIS-AUTO ready for actuation
3.14
retraction of needle

function which removes the needle from the target tissue to a predefined minimum needle point position

inside the NIS-AUTO
3.15
risk assessment
overall process comprising a risk analysis (estimation) and a risk evaluation
NOTE Adapted from ISO 14971:2007, definition 2.18.
3.16
sharps injury protection feature
function that prevents accidental sharps injury

NOTE The NIS-AUTO might provide an active or passive automated function (definitions of active and passive safety

features are given in ISO 23908), distinct from needle shielding or hiding, which is designed to minimize the risks of accidental

sharps injury. The NIS-AUTO cannot claim to have sharps injury protection unless it meets the requirements of ISO 23908.

3.17
target tissue

location in the body into which the medicinal product is delivered and that defines the route of administration

NOTE Parts of the body for this part of ISO 11608 can include the dermis, subcutaneous tissue and muscle.

4 Requirements
4.1 General requirements
a) The NIS-AUTO shall be designed to avoid unintended actuation.

b) The NIS-AUTO shall perform its intended automated functions when tested following pre-conditioning

(including free fall) in accordance with ISO 11608-1.
© ISO 2012 – All rights reserved 3
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)

EXAMPLE A NIS-AUTO that is dropped on a surface in accordance with free fall testing as described in ISO 11608-1

and that fails to perform any automated function as described in the instructions for use is deemed to have failed.

c) Completion of an automated function shall be apparent by visual and either tactile or audible means,

or both, unless otherwise specified in any subclause of this part of ISO 11608, even if the sequence of

operations for the NIS-AUTO consists of only one action. An automated function can be a sequence; if so,

completion of the entire sequence shall be apparent to the user.

d) The NIS-AUTO shall not compromise container (drug product quality, consistency, etc.) and/or needle

sterility. Devices designed to deliver more than one dose shall have an intermediate preparation step prior

to delivery of each dose.

e) Where requirements do not specify forces for actuation of the automated feature/function, the appropriate

force shall be determined by using a risk-based approach (consistent with ISO 14971) supported by

simulated user studies that mimic actual clinical use.

NOTE The study design should be based on statistical considerations and should have clear acceptance criteria.

Guidance on conducting simulated user studies can be found in IEC 62366.

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

requiring another “setup” step before it can be used again). The NIS-AUTO shall provide visual feedback

indicating clearly the state of the NIS-AUTO (i.e. unused, ready for use or disabled).

g) Manufacturers shall define the injection depth determined by the target tissue through clinical evaluation.

Design verification shall demonstrate that the device is capable of delivering each dose of the medicinal

product to the target tissue.

h) Where requirements in this part of ISO 11608 provide a test method without acceptance criteria, the manufacturer

shall establish a specification and acceptance criteria for the automated feature/function appropriate to the

intended use of the device using a risk-based approach (consistent with ISO 14971 and IEC 62366).

4.2 Preparation
4.2.1 General

The NIS-AUTO shall be designed to ensure that all preparation steps involving the NIS-AUTO are completed

in the intended order or designed such that, if preparation steps are done out of sequence, continued safe and

effective use of the NIS-AUTO is possible.

The NIS-AUTO shall indicate to the user that the preparation procedure has been completed. This shall be

apparent to the user at least by visible means.
4.2.2 Drug product preparation (e.g. reconstitution)

Automated drug preparation shall not have an adverse impact on the drug product. Once preparation is

complete, the contents of the container shall be visible to confirm the medicinal product has been properly

prepared in accordance with the instructions for use, unless visibility adversely affects the drug product and/or

therapy (see rationale in Annex A).
4.2.3 Needle preparation

The needle shall not be damaged by the automated feature (needle attachment, removal of needle cover, etc.).

The automated needle preparation function shall not adversely affect the intended safety and performance of

the NIS-AUTO. If any portion of the needle preparation (needle attachment, removal of needle cover, etc.) is

automated, the NIS-AUTO shall not increase the potential of coring of any elastomeric components.

4 © ISO 2012 – All rights reserved
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
4.2.4 Air removal and/or priming

If the NIS-AUTO includes automated air removal and/or priming, the system shall still be able to deliver the

pre-defined dose after the action is completed.
NOTE Air removal and priming can be combined into one step.
4.2.5 Dose setting

In the case of a variable dose NIS-AUTO, if designed to automatically set a dose, it shall indicate the set dose

to the user by at least visual means and allow a means to adjust the set dose as appropriate.

4.3 Injection
4.3.1 Needle hiding

Needle hiding shall not interfere at any time with the NIS-AUTO intended function. If hiding the needle is

required before, during or after injection, the needle shall not be visible to the user when tested in accordance

with 5.1.11.1.

NOTE Post-injection needle hiding is not considered to be sharps injury protection.

4.3.2 Actuation of injection

A minimum of two manual actions shall be required in order to use the system, i.e. 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.

4.3.3 Needle insertion and extension
4.3.3.1 Insertion distance

Automated needle insertion shall extend the needle tip to the specified position. This shall be confirmed through

measurement of the needle extension in accordance with the methods in 5.1.7.

The manufacturer shall demonstrate that the required needle extension results in needle penetration consistent

with the intended use.

The minimum force against the skin required to actuate the NIS-AUTO to achieve adequate needle insertion

shall be determined in order to ensure complete penetration to the intended injection depth.

An adjustment to the needle extension specification may be required for those NIS-AUTOs that, when pressed

against the skin, cause skin doming (see Figure 1). Any adjustment to this specification shall be determined by

the manufacturer’s risk assessment.
© ISO 2012 – All rights reserved 5
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
Key
1 NIS-AUTO
2 skin doming (if applicable)
3 skin
Figure 1 — Skin doming (if applicable)
4.3.3.2 Needle damage
The needle shall not be damaged by the automated feature.
4.3.3.3 Dose delivery

The sequence and timing of insertion when performed in conjunction with an automated injection shall not

cause incomplete delivery of the dose to the intended injection depth.

NOTE This requirement can be verified as a separate study, or can be verified during full dose accuracy testing using

the method in 5.1.9.1.

The risk assessment shall address the potential hazard to the patient of any portion of the liquid that may be

delivered outside the intended injection depth.
4.3.4 Injection of the medicinal product

Each dose shall be delivered into the intended injection depth. Dose accuracy shall be confirmed through the

methods given in 5.1.8.
6 © ISO 2012 – All rights reserved
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)

The NIS-AUTO shall provide confirmation of completion of the automated injection in an unmistakable and

clear manner. Such confirmation shall be at least a persistent visual indication. This indication shall be reset

between injections for multi-dose NIS-AUTOs.
NOTE Additional tactile and/or audible indicator(s) may be included.

The instructions for use shall clearly cover the actions to be taken by the user in the event of failure of the NIS-

AUTO to deliver the medicinal product.
4.3.5 Needle retraction
4.3.5.1 Completion of dose delivery

The sequence and timing of the retraction shall not cause incomplete delivery of the dose to the intended

injection site.

NOTE This requirement can be verified as a separate study, or can be verified during full dose accuracy testing using

the method in 5.1.9.1.

The risk assessment shall address the potential hazard to the patient of any portion of the liquid that may be

delivered outside the intended injection depth.
4.3.5.2 Retraction
...

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