SIST EN ISO 11608-5:2013
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
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.
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - 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
Relations
Standards Content (Sample)
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
2
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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.
3
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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
RA
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.
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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.
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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.
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SIST EN ISO 11608-5:2013
ISO 11608-5:2012(E)
1
3
2
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.
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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
...
SLOVENSKI STANDARD
oSIST prEN ISO 11608-5:2011
01-februar-2011
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del:
Avtomatizirane funkcije (ISO/DIS 11608-5:2010)
Needle-based injection systems for medical use - Requirements and test methods - Part
5: Automated functions (ISO/DIS 11608-5:2010)
Nadelbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO/DIS 11608-5:2010)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 5: Fonctions automatisées (ISO/DIS 11608-5:2010)
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 11608-5:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11608-5:2011
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oSIST prEN ISO 11608-5:2011
EUROPEAN STANDARD
DRAFT
prEN ISO 11608-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2010
ICS 11.040.25
English Version
Needle-based injection systems for medical use - Requirements
and test methods - Part 5: Automated functions (ISO/DIS 11608-
5:2010)
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/DIS 11608-5:2010) Automatisierte Funktionen (ISO/DIS 11608-5:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11608-5:2010: E
worldwide for CEN national Members.
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oSIST prEN ISO 11608-5:2011
prEN ISO 11608-5:2010 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 11608-5:2011
prEN ISO 11608-5:2010 (E)
Foreword
This document (prEN ISO 11608-5:2010) 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 document is currently submitted to the parallel Enquiry.
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(s).
Endorsement notice
The text of ISO/DIS 11608-5:2010 has been approved by CEN as a prEN ISO 11608-5:2010 without any
modification.
3
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oSIST prEN ISO 11608-5:2011
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oSIST prEN ISO 11608-5:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 11608-5
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2010-10-28 2011-03-28
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
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
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
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.
©
International Organization for Standardization, 2010
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oSIST prEN ISO 11608-5:2011
ISO/DIS 11608-5
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ISO/DIS 11608-5 (N 153)
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 Preparation . 4
4.2.1 General . 4
4.2.2 Drug product preparation (e.g. reconstitution) . 4
4.2.3 Needle preparation . 5
4.2.4 Air removal and/or priming. 5
4.2.5 Dose setting . 5
4.3 Injection . 5
4.3.1 Needle hiding . 5
4.3.2 Actuation of injection . 5
4.3.3 Needle insertion and extension . 5
4.3.4 Injection of the medicinal product . 6
4.3.5 Needle retraction . 7
4.3.6 Disabling the NIS-AUTO (single-use NIS-AUTOs or last dose from multiple-dose
disposable NIS-AUTOs) . 7
4.3.7 Needle shielding . 7
4.3.8 Needle removal from the NIS-AUTO . 8
4.4 Risk analysis requirements . 8
5 Test methods . 8
5.1 General . 8
5.1.1 Drug product preparation (e.g. reconstitution) . 8
5.1.2 Needle preparation . 8
5.1.3 Air removal and/or priming. 8
5.1.4 Automatic dose setting and memory . 9
5.1.5 Actuation . 9
5.1.6 Needle extension . 9
5.1.7 Injection . 9
5.1.8 Needle insertion/needle retraction . 9
5.1.9 Disabling the NIS-AUTO . 10
5.1.10 Pre/post injection needle hiding and shielding . 11
5.2 Dose specification requirements . 11
5.3 Uncertainty of measurements and conformance with specifications . 11
6 Test report . 12
7 Information to be supplied by the manufacturer . 12
Annex A (informative) Rationale for requirements . 13
A.1 Rationale for requirements (clause 4) . 13
Bibliography . 16
© ISO 2010 – All rights reserved iii
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ISO/DIS 11608-5 (N 153)
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 cartridges and syringes
Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
Part 5: Automated functions
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ISO/DIS 11608-5 (N 153)
Introduction
This standard applies to Needle Injection Systems with Automated functions (NIS-AUTO) primarily intended to
administer medicinal products to humans. Because of the anticipated variation in the designs of of NIS-
AUTOs, this standard is promulgated more as a “horizontal” than “vertical” one. Thus, it will tend 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.
These standards intentionally avoid addressing more than the most basic elements regarding the safety and
performance of needle-based injection systems with automated functions 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 shall fall under the authority of national governments or supranational agencies regulating
the manufacture and marketing of medical NIS-AUTOs and pharmaceutical products. These standards are
expected to be supplemented by additional requirements and may 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, these
standards avoid setting forth design specifications for the uniform size, shape, and interface of such
containers. This issue is left for future initiatives to build upon the standards promulgated herein.
The sampling plans for inspection selected for this standard are intended to verify the design, at a high
confidence level. The sampling plan does not replace the more general manufacturing quality systems,
including lot release, which appear in standards on quality systems, e.g. the ISO 9000 series or ISO 13485.
All references to function in this standard are by definition to be construed as automated functions (defined).
This standard does not apply to these functions if they are performed manually by the user.
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oSIST prEN ISO 11608-5:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 11608-5 (N 153)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 5:
Automated functions
1 Scope
This standard specifies requirements and test methods for the following needle-based injection systems with
automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in
humans:
drug product preparation (e.g. reconstitution)
needle preparation
air removal
priming
dose setting
actuation
needle insertion
injection of the medicinal product
needle retraction
disabling the NIS-AUTO
needle shielding or hiding
sharps injury protection
NOTE The NIS-AUTO may provide an automated function (whether active or passive per the definition in ISO 23908)
that is designed to minimize the risks of accidental sharps injury, which is distinct from needle shielding or hiding. In order
to make the claim of sharps injury protection, the NIS-AUTO must also meet the requirements of ISO 23908.
needle removal.
This standard will reference as appropriate and not duplicate requirements and test methods in ISO 11608 (all
parts), ISO 8537, ISO 7886 and ISO 23908.
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.
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ISO 16269-6:2005, Statistical interpretation of data - Part 6: Determination of statistical tolerance intervals
1
ISO 11608-1: , Needle-based injection systems for medical use — Requirements and test methods - Part 1:
Needle-based injection systems
1
ISO 11608-2: , Needle-based injection systems for medical use — Requirements and test methods - Part 2:
Needles
1
ISO 11608-3: , Needle-based injection systems for medical use — Requirements and test methods - Part 3:
Finished container closures
ISO 11608-4:2006, Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and
electromechanical pen-injectors
ISO 14971:2007, Medical devices - Application of risk management to medical devices
ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes
1
ISO 23908: , Sharps injury protection – Requirements and methods - Sharps protection features for single-
use hypodermic needles, introducers for catheters and needles used for blood sampling
IEC 60068-2-30:2005, Ed. 3 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 + 12 h
cycle)
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
ISO/IEC Guide 98:1995, Guide to the Expression of Uncertainty in Measurement (GUM)
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 needle-based injection
system with automated functions
EXAMPLE A magnifying lens to aid reading of dose setting, any grip enhancer, dose counter.
3.2
actuation
motion which initiates a NIS-AUTO function, such as needle insertion, triggered by the actions of the NIS-
AUTO user (or by another automated function), such as 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.
1
To be developed
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3.5
injection
function(s) which deliver the dose to the intended injection depth
3.6
intended injection depth
range of injection depth at which the drug is intended to be delivered
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 NIS-AUTO
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 intended to protect the needle from damage and users from injury prior to use of
the needle
3.9
needle hiding
function which obscures the needle from the user's sight either before, during or after the injection cycle.
Hiding the needle only has a visual requirement designed to reduce patient trauma in case of needle phobia
and does not require any physical or dimensional requirements meant to restrict access to the needle. It does
not imply any increased level of safety from needle stick injuries
3.10
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
3.11
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 may reduce the risk of damage and contamination of the needle before use and may 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.
3.12
priming
function that readies the dosing mechanism of the NIS-AUTO for actuation
3.13
retraction of needle
function which removes the needle out of the target tissue to a predefined minimum needle point position
inside the NIS-AUTO
3.14
risk assessment (RA)
overall process comprising a risk analysis (estimation) and a risk evaluation
[ISO 14971:2007, definition 2.18]
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3.15
sharps injury protection feature
function that prevents accidental sharps injury
3.16
target tissue
location in the body into which the medicinal product is delivered and that defines the route of administration
NOTE Location of the parts of the body for this standard can include the dermis, subcutaneous tissue, and muscle.
4 Requirements
4.1 General requirements
The NIS-AUTO shall be designed to avoid unintended actuation.
Completion of an automated function shall be apparent by visual and either tactile and/or audible means
unless otherwise specified in any sub clause of this standard.
NOTE 1 An automated function may be a sequence and completion of the entire sequence shall be apparent to the
user.
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.
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 2 The study design should be based on statistical considerations and should have clear acceptance criteria.
Guidance on conducting simulated user studies is outlined in IEC 62366:2007.
Users shall be able to clearly distinguish between an unused, in-use, and a disabled NIS-AUTO. The NIS-
AUTO shall provide visual feedback indicating clearly the state of the NIS-AUTO (i.e. unused, ready for
use or disabled).
Manufacturers shall define the injection depth determined by the target tissue through clinical evaluation.
Design verification shall demonstrate the device is capable of delivering each dose of the medicinal
product to the target tissue.
4.2 Preparation
4.2.1 General
The NIS-AUTO shall be designed to ensure that all preparation steps involving the NIS-AUTO shall be
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 provide indication 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
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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.
4.2.4 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 dos
...
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