EN ISO 11608-5:2012

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

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.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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.
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.
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
ISO 11608-5:2012(E)
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
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E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2012 – All rights reserved

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 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

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.
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 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

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.
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 manufactur
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