SIST EN ISO 11608-5:2023
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
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)
Ta del standarda ISO 11608 določa zahteve in preskusne metode za avtomatizirane funkcije peres za injiciranje (navedene v standardu kot NIS-AUTO), ki so namenjene dajanju zdravil ljudem. Ta dokument ne obravnava oddaljene komunikacije iz NIS-AUTO.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11608-5:2023
01-maj-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: EN ISO 11608-5:2023
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11608-5:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 11608-5:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 11608-5:2023
EN ISO 11608-5
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2023
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-5:2012
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 5: Automated
functions (ISO 11608-5:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 5: Fonctions Verwendung - Anforderungen und Prüfverfahren - Teil
automatisées (ISO 11608-5:2022) 5: Automatisierte Funktionen (ISO 11608-5:2022)
This European Standard was approved by CEN on 10 March 2023.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-5:2023 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11608-5:2023
EN ISO 11608-5:2023 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 11608-5:2023
EN ISO 11608-5:2023 (E)
European foreword
The text of ISO 11608-5:2022 has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 11608-5:2023 by 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 September 2023, and conflicting national standards
shall be withdrawn at the latest by September 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11608-5:2012.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11608-5:2022 has been approved by CEN as EN ISO 11608-5:2023 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 11608-5:2023
---------------------- Page: 6 ----------------------
SIST EN 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
---------------------- Page: 7 ----------------------
SIST EN 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN 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
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN 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.
iv
© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN 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.
v
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 11608-5:2023
---------------------- Page: 12 ----------------------
SIST EN 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
1
© ISO 2022 – All rights reserved
---------------------- Page: 13 ----------------------
SIST EN 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.
2
© ISO 2022 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN 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)
3
© ISO 2022 – All rights reserved
---------------------- Page: 15 ----------------------
SIST EN ISO 11608-5:2023
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
4
© ISO 2022 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN 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 preparat
...
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.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 11608-5:2023
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
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
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
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.
iv
© ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
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.
v
© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 11608-5:2023
---------------------- Page: 8 ----------------------
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
1
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
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.
2
© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
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)
3
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
oSIST prEN ISO 11608-5:2023
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
4
© ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
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.
5
© ISO 2022 – All rights reserved
---------------------- Page: 13 ----------------------
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.
6
© ISO 2022 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 11608-5:2023
ISO 11608-5:2022(E)
4.9 Dose delivery
The dose accurac
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.