FprEN ISO 11608-5

SLOVENSKI STANDARD
01-april-2020
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del:
Avtomatizirane funkcije (ISO/DIS 11608-5:2020)
Needle-based injection systems for medical use - Requirements and test methods - Part
5: Automated functions (ISO/DIS 11608-5:2020)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO/DIS 11608-5:2020)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 5: Fonctions automatisées (ISO/DIS 11608-5:2020)
Ta slovenski standard je istoveten z: prEN ISO 11608-5
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-5
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2020-02-18 2020-05-12
Needle-based injection systems for medical use —
Requirements and test methods —
Part 5:
Automated functions
Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai —
Partie 5: Fonctions automatisées
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
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ISO/DIS 11608-5:2020(E)
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©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020

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

ISO/DIS 11608-5:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 4
4.1 General requirements . 4
4.2 Medicinal product preparation . 5
4.3 Needle preparation . 5
4.4 Needle hiding. 6
4.5 Priming . 6
4.6 Dose setting . 6
4.7 Needle insertion . 6
4.8 Injection depth control . 6
4.9 Dose delivery . 6
4.10 Device function information. 6
4.11 Needle retraction . 6
4.11.1 Completion of dose delivery . 6
4.11.2 Needle retraction distance . 7
4.11.3 Communication of completion . 7
4.12 Disabling the NIS-AUTO . 7
4.13 Needle shielding . 7
4.13.1 General. 7
4.13.2 Needle shielding before injection . 7
4.13.3 Needle shielding after injection . 7
4.14 Needle removal from the NIS-AUTO . 8
5 Test methods . 8
5.1 General . 8
5.2 Test conditions . 8
5.3 Actuation . 8
5.4 Medicinal product preparation . 8
5.5 Needle inspection . 8
5.6 Needle hiding. 9
5.7 Priming . 9
5.8 Needle extension .10
5.9 Injection time .10
5.10 Dose accuracy .10
5.11 Retracted position .10
5.12 Disabling the NIS-AUTO .10
5.13 Needle shielding .11
5.13.1 Needle shielding before and after injection .11
5.13.2 Needle shielding after free fall .11
6 Information to be supplied by the manufacturer .11
Annex A (informative) Rationale for requirements .12
Annex B (informative) Example of a test method for dose accuracy at intended injection depth .14
Annex C (informative) Needle extension and intended injection depth .16
Bibliography .21
ISO/DIS 11608-5:2020(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 meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.
This document was prepared by ISO/TC 84 Devices for administration of medicinal products and
catheters.
This second edition cancels and replaces the first edition (ISO 11608-5:2012), which has been
technically revised.
Information about the revision history of the ISO 11608 series can be found in ISO 11608-1:20##.
A list of all parts in the ISO 11608 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

ISO/DIS 11608-5:2020(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. Because of the anticipated
variation in the designs of NIS-AUTOs, it tends to specify the results of the design effort instead of the
physical and construction requirements used as the basis for NIS-AUTO design, so that innovation in
achieving the intended purposes is not unnecessarily restricted. As such, this document intends to
address basic elements regarding the safety and performance of NIS-AUTOs.
Despite certain advantages for intentional interchangeability for containers designed for different auto-
injection systems, as well as the potential risks of inadvertent interchangeability, this document avoids
setting forth design specifications for the uniform size, shape and interface of such containers. It is left
for future initiatives to build upon the specifications in this document.
ISO 11608-1 is the umbrella document of the ISO 11608 series. All other parts, including this document,
are to be used in conjunction with ISO 11608-1.
Guidance on transition periods for implementing the requirements of this document is given in
ISO/TR 19244.
DRAFT INTERNATIONAL STANDARD ISO/DIS 11608-5:2020(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 5:
Automated functions
1 Scope
This document specifies requirements and test methods for needle-based injection systems with
automated functions (NIS-AUTO), including but not limited to:
a) medicinal product preparation (e.g. reconstitution);
b) needle preparation;
c) needle hiding;
d) priming;
e) dose setting;
f) needle insertion;
g) injection depth control;
h) injection of the medicinal product;
i) recording;
j) disabling the NIS-AUTO;
k) needle retraction;
l) needle shielding;
m) needle removal.
This document does not cover remote communication from the NIS-AUTO.
Automated features not included in the list above shall be specified and tested in accordance with the
principles of this document.
All references to "function" in this document are by definition to be construed as automated functions
(see 3.2). This document does not apply to these functions if they are performed manually by the user.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
1)
ISO 11608-1 , Needle-based injection systems for medical use — Requirements and test methods — Part 1:
Needle-based injection systems
1) To be published (revises ISO 11608-1:2012). Stage at time of publication: ISO/DIS 11608-1:2020.
ISO/DIS 11608-5:2020(E)
ISO 23908:2011, Sharps injury protection — Requirements and test methods — Sharps protection features
for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11608-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
actuation
action which initiates a NIS-AUTO function (e.g. needle insertion (3.14)), carried out by the NIS-AUTO
user (or by another automated function (3.2))
EXAMPLE Pressing the NIS-AUTO (3.9) against the injection site.
3.2
automated function
function which does not require user interaction after actuation (3.1)
Note 1 to entry: A dose counter is considered an automated function if it changes its state without any user
interaction.
3.3
disabling
function that changes the state of the NIS-AUTO (3.9) such that it is not able to be refilled, reloaded,
reset, or reactivated for dose delivery, which will allow the NIS-AUTO (3.9) to perform any subsequent
injections (including single-dose and the last dose of multi-dose systems)
3.4
dose setting (and memory)
function which sets the dose to be delivered (dose setting) and/or displays the previously set dose
(memory)
3.5
injection of medicinal product
function which delivers the dose
3.6
injection time
time from actuation (3.1) to completion of the injection of medicinal product (3.5) as described in the IFU
3.7
intended injection depth
range of distance from the skin surface to the point at which the medicinal product is intended to be
delivered
Note 1 to entry: See Figures in Annex C.
3.8
medicinal product preparation
function which prepares the medicinal product for administration (e.g. reconstitution)
2 © ISO 2020 – All rights reserved

ISO/DIS 11608-5:2020(E)
3.9
needle-based injection system with automated function
NIS-AUTO
injection system that delivers a medicinal product through a needle wherein one or a series of functions
are initiated by an action of the user and controlled automatically by the injection system
Note 1 to entry: Accessories that perform automatic functions in combination with manual injection NIS-AUTOs
are regarded as NIS-AUTO.
3.10
needle cover
cover provided over a needle in order to protect the needle from damage and users from injury
prior to use
Note 1 to entry: A needle cover alone is not a sharps injury protection feature unless it complies with ISO 23908.
3.11
injection depth control
function which controls the needle extension (3.12) such that the medicinal product is delivered at the
intended injection depth (3.7)
3.12
needle extension
axial distance from the patient end of the needle tip to the nearest part of the NIS-AUTO body (defining
the point of contact with the patient adjacent to the injection site)
3.13
needle hiding
function which intentionally obscures the needle from the user's sight either before, during or after the
injection cycle
Note 1 to entry: The needle hiding function only has a visual requirement. It is not subject to any physical or
dimensional requirements intended to restrict access to the needle. It does not imply any increased level of safety
from needle stick injuries.
3.14
needle insertion
function which inserts the needle into the injection site to the intended injection depth (3.7) prior to the
injection of the medicinal product
3.15
needle preparation
function which prepares the needle for use (e.g. needle attachment, removal of needle cover (3.10), etc.)
Note 1 to entry: The needle preparation function may be a feature of the design and not a mechanical action.
For example, a NIS cap may contain features that interact with the needle cover (3.10) and when the NIS cap is
removed, the needle cover (3.10) is automatically removed.
3.16
needle removal
function which disconnects the needle from the NIS-AUTO fluid path
3.17
needle retraction
function which removes the needle from the target tissue to a predefined position inside the NIS-
AUTO (3.9)
ISO/DIS 11608-5:2020(E)
3.18
needle shielding
function which covers the needle before and/or after the injection cycle to reduce the likelihood of
direct contact with the needle
Note 1 to entry: Needle shielding alone is not a sharps injury protection feature unless it complies with ISO 23908.
3.19
priming
function that makes the dosing mechanism of the NIS-AUTO (3.9) ready for dose administration (e.g.
removing the air from the fluid path)
Note 1 to entry: Needle preparation (3.15) and fluid path connection should be considered separately.
3.20
recording
function which records information (e.g. dose counter)
Note 1 to entry: A NIS-AUTO (3.19) may include several different, possibly related, recording functions, which
record different pieces of information related to the dose administered.
4 Requirements
4.1 General requirements
a) Any automated function considered a primary function shall be verified in accordance with
ISO 11608-1.
b) Where the completion of an automated function is intended to be communicated to the user, it shall
be apparent by visual means; and either tactile or audible means (i.e. visual and tactile, visual and
audible) unless otherwise specified in this document.
c) Users shall be able to clearly distinguish between a NIS-AUTO that is unused, in use, used or
disabled or requiring another "setup" step before it can be used again. For automated functions
that change the state of the NIS-AUTO, a visual indication of the NIS-AUTO state shall be provided
(e.g. ready for use in use, disabled or other states relevant for the particular NIS-AUTO).
d) Where the design of a NIS-AUTO allows manual operations to be performed in a sequence other
than that specified in the instructions for use, the risk assessment shall address the risks of out-of-
sequence operation.
e) Actuation of each automated function shall meet the following requirements:
1) Actuation of injection: A minimum of two manual actions shall be required in order to initiate
injection, e.g. from locked to unlocked state/ready for injection, then press to actuate. A
multi-dose/use injection system with automated functions, once actuated, shall not allow an
additional actuation without a separate and distinct action prior to a subsequent actuation.
2) Actuation shall be tested in accordance with 5.3.
f) Automated functions shall not interfere with the primary functions of the NIS-AUTO.
g) For each automated function included within the NIS-AUTO design, the manufacturer shall apply
the applicable requirements in this paragraph and perform testing in accordance with Clause 5.
Where the design does not include the automated function, or does not automate the function,
the relevant requirements of Clause 4 do not apply, and testing in accordance with the sections of
Clause 5 is not needed. Refer to Table 1 for a matrix of the specific requirements and test methods
for each automated function.
4 © ISO 2020 – All rights reserved

ISO/DIS 11608-5:2020(E)
Table 1 — Requirements and test methods for automated functions (Ref. 4.1)
Automated function Requirement Test method
Medicinal product preparation 4.2 Medicinal product preparation 5.4 Medicinal product preparation
Needle preparation 4.3 Needle preparation 5.5 Needle inspection
Needle hiding 4.4 Needle hiding 5.6 Needle hiding
Priming 4.5 Priming 5.7 Priming
Dose setting 4.6 Dose setting Per risk assessment
Needle insertion 4.7 Needle insertion 5.5 Needle inspection
Needle extension control 4.8 Injection depth control 5.8 Needle extension
Inject medicinal product 4.9 Dose delivery 5.10 Dose accuracy
5.9 Injection time
Recording 4.10 Device function information Per risk assessment
Disabling 4.12 Disabling the NIS-AUTO 5.12 Disabling the NIS-AUTO
Needle retraction 4.11 Needle retraction 5.10 Dose accuracy
5.11 Retracted position
Needle shielding 4.13 Needle shielding 5.13 Needle shielding
Needle removal 4.14 Needle removal from the Test method references included in
NIS-AUTO requirement
NOTE Statistical requirements are specified in ISO 11608-1.
4.2 Medicinal product preparation
Automated medicinal preparation shall not have an adverse impact on the medicinal product. The NIS-
AUTO shall indicate to the user that the automated medicinal product preparation has been completed
by at least visual means.
If risk assessment determines that it is necessary for the user to confirm that the medicinal product has
been properly prepared, then the NIS-AUTO shall:
a) allow the user to perform visual inspection of the medicinal product; and/or
b) provide feedback that the medicinal product has been properly prepared.
Medicinal product preparation shall be tested in accordance with 5.4.
4.3 Needle preparation
The needle shall not be damaged by the automated function (needle attachment, removal of needle
cover, etc.). If any portion of the needle preparation is an automated function and involves piercing of
an elastomeric component the NIS-AUTO sh
...