kSIST FprEN ISO 21649:2022

Needle-free injection systems for medical use - Requirements and test methods (ISO/FDIS 21649:2022)

This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.
The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.
Excluded from this document are drug delivery methods which:
—    involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);
—    generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);
—    deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);
—    apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);
—                        infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.

Kanülenlose Injektionsgeräte zur medizinischen Anwendung - Anforderungen und Prüfverfahren (ISO/FDIS 21649:2022)

Dieses Dokument ist anwendbar für die Sicherheits-, Leistungs- und Prüfanforderungen für kanülenlose Injektionssysteme (NFIS) zum Einmalgebrauch und zur Wiederverwendung, die für die Anwendung am Menschen in Kliniken und anderen medizinischen Einrichtungen sowie für die persönliche Anwendung durch Patienten vorgesehen sind.
Die Dosierkammer des NFIS ist oft ein Wegwerfartikel und dafür vorgesehen, nach einem einzigen Gebrauch oder einer begrenzten Anzahl von Verwendungen ersetzt zu werden. Sie ist manchmal vom Injektionsmechanismus abnehmbar und wird oft als „Patrone“, „Ampulle“, „Spritze“, „Kapsel“ oder „Scheibe“ bezeichnet. Im Gegensatz dazu kann die Dosierkammer auch eine dauerhafte innere Kammer, die so ausgelegt ist, dass sie über die festgelegte Lebensdauer des Geräts haltbar ist, sowie ein zusätzliches oder mehrere zusätzliche Teile, die das Risiko der Kreuzkontamination ausschließen, enthalten.
Von diesem Dokument ausgeschlossen sind Verfahren zur Medikamentenabgabe, die:
   mit einer Durchbohrung eines Teils des Geräts selbst in die oder durch die Haut oder Schleimhäute einher gehen (wie Kanülen, Nadeln, Mikrokanülen, implantierbare Geräte zur langsamen Medikamentenabgabe);
   Aerosole, Tröpfchen, Pulver oder andere Rezepturen für die Inhalation, das Einblasen oder die Ablagerung im Nasen- und Mundbereich erzeugen (wie Sprays, Inhalatoren, Vernebler);
   Flüssigkeiten, Pulver oder andere Substanzen auf der Oberfläche von Haut oder Schleimhäuten zur passiven Diffusion oder Aufnahme in den Körper ablagern (wie Transkutanpflaster, Flüssigkeitstropfen);
   Schall- oder elektromagnetische Energie anwenden (wie Ultraschall- oder Iontophoresegeräte);
   Infusionssysteme zur Verabreichung oder Dosierung von Medikamenten in oder durch Systeme künstlicher Schläuche, Katheter und/oder Kanülen sind, die in den Körper eintreten.

Systèmes d'injection sans aiguille pour usage médical - Exigences et méthodes d'essai (ISO/FDIS 21649:2022)

Injektorji brez igle za uporabo v medicini - Zahteve in preskusne metode (ISO/FDIS 21649:2022)

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Apr-2022
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 02-Dec-2022
• Due Date: 20-Jan-2023
• Completion Date: 19-Dec-2022
• Ref Project: FprEN ISO 21649 - Needle-free injection systems for medical use - Requirements and test methods (ISO/FDIS 21649:2022)

Relations

• Revised: SIST EN ISO 21649:2010 - Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
• Effective Date: 09-Feb-2021
• Revised: SIST EN ISO 21649:2010 - Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 21649:2022
01-april-2022

Injektorji brez igle za uporabo v medicini - Zahteve in preskusne metode (ISO/DIS

21649:2022)
Needle-free injection systems for medical use - Requirements and test methods
(ISO/DIS 21649:2022)
Kanülenlose Injektionsgeräte zur medizinischen Anwendung – Anforderungen und
Prüfverfahren (ISO/DIS 21649:2022)

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

(ISO/DIS 21649:2022)
Ta slovenski standard je istoveten z: prEN ISO 21649
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 21649:2022 en,fr,de

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

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oSIST prEN ISO 21649:2022
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oSIST prEN ISO 21649:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21649
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2022-02-14 2022-05-09
Needle-free injection systems for medical use —
Requirements and test methods
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 21649:2022(E)
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. © ISO 2022
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oSIST prEN ISO 21649:2022
ISO/DIS 21649:2022(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
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Phone: [phone]
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Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
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oSIST prEN ISO 21649:2022
ISO/DIS 21649:2022(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction .............................................................................................................................................................................................................................. vi

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

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

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

4 Symbols and abbreviated terms..........................................................................................................................................................4

5 Requirements .......................................................................................................................................................................................................... 5

5.1 General requirements ...................................................................................................................................................................... 5

5.2 Noise requirements ............................................................................................................................................................................ 6

5.3 Dose accuracy specification requirements ................................................................................................................... 7

5.4 Usability engineering ........................................................................................................................................... ............................. 7

5.5 Risk approach .......................................................................................................................................................................................... 7

5.6 Uncertainty of measurements and conformance with specifications .................................................. 8

5.7 Performance profile requirements ...................................................................................................................................... 8

5.8 Test requirements................................................................................................................................................................................ 9

5.8.1 NFISs subjected to standard, cool and hot atmospheres and after claimed

lifetime testing (in-use conditions) ................................................................................................................... 9

5.8.2 Dry heat storage - Preconditioning ................................................................................................................... 9

5.8.3 Damp heat storage – Preconditioning ............................................................................................................. 9

5.8.4 Cold storage - Preconditioning ........................................................................................................................... 10

5.8.5 Cyclical testing - Preconditioning .................................................................................................................... 10

5.8.6 Free fall - Preconditioning ...................................................................................................................................... 10

5.8.7 Vibration and shock - Preconditioning ........................................................................................................ 10

5.8.8 Transport – Preconditioning ................................................................................................................................ 11

5.8.9 NFISs with electrical components subjected to electromagnetic

compatibility (EMC) ..................................................................................................................................................... 11

5.8.10 Water and dust resistance ......................................................................................................................................12

5.8.11 Auto-disable feature ....................................................................................................................................................12

6 Test methods .........................................................................................................................................................................................................12

6.1 General ........................................................................................................................................................................................................12

6.2 Test procedures .................................................................................................................................................................................. 13

6.2.1 General .....................................................................................................................................................................................13

6.2.2 NFISs subjected to standard, cool and hot atmospheres and claimed

lifetime test .......................................................................................................................................................................... 14

6.2.3 NFISs subjected to dry heat storage atmosphere .............................................................................. 16

6.2.4 NFISs subjected to damp-heat storage atmosphere ........................................................................ 16

6.2.5 NFISs subjected to cold storage atmosphere ......................................................................................... 17

6.2.6 NFISs subjected to a cyclical atmosphere ................................................................................................. 17

6.2.7 NFISs subjected to free fall .................................................................................................................................... 18

6.2.8 NFISs subjected to vibration and shock .................. .................................................................................... 19

6.2.9 NFISs with electrical components subjected to electromagnetic

compatibility (EMC) testing .................................................................................................................................. 20

6.2.10 Noise testing ........................................................................................................................................................................20

6.2.11 Water and dust resistance ...................................................................................................................................... 22

6.2.12 Auto-disable feature .................................................................................................................................................... 22

6.3 Test evaluations .................................................................................................................................................................................. 23

6.3.1 Dose accuracy ....................................................................................................................................................................23

6.3.2 Inspection .............................................................................................................................................................................. 24

7 Test report ...............................................................................................................................................................................................................25

8 Information supplied with the NFIS .............................................................................................................................................25

8.1 General ........................................................................................................................................................................................................ 25

iii
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oSIST prEN ISO 21649:2022
ISO/DIS 21649:2022(E)

8.2 Marking ...................................................................................................................................................................................................... 25

8.3 Instructions for use ......................................................................................................................................................................... 26

Annex A (informative) Two-sided tolerance limit factors (k) ................................................................................................27

Annex B (informative) Examples of accuracy limit calculations and random settings..............................33

Annex C (normative) Instructions for use, marking and age warning symbol ...................................................34

Annex D (informative) Example for k factor .............................................................................................................................................37

Bibliography .............................................................................................................................................................................................................................38

© ISO 2022 – All rights reserved
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oSIST prEN ISO 21649:2022
ISO/DIS 21649:2022(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 21649:2006), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— Changes to update the document to be consistent with the approach and requirements currently in

the updated ISO 11608 series. This includes:
— Use of a risk-based approach to specifications and testing;
— Damp heat testing;
— Water and dust intrusion;
— Transport and lifetime testing.
— Changes to address requirements for mass vaccinations such as :

— Requirements to reduce the potential for cross contaminations, such as a requirement for a

re-use prevention feature/auto-disable feature for the patient contact portion of a re-usable/

multi-use device;

— Address robustness requirements of the WHO PQ specification into the document, including

long-term repetitive use and for use in harsh environments;

— Include specific requirement and a test method to address potential transfer of pathogens

between patients.

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.
© ISO 2022 – All rights reserved
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oSIST prEN ISO 21649:2022
ISO/DIS 21649:2022(E)
Introduction

This document applies to needle-free injection systems (NFISs) primarily intended to administer

medicinal products to humans. Because of the anticipated variation in the designs of such a broad

array of devices, this document is promulgated more as a “horizontal” rather than a “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 device design, so that innovation in achieving the intended purposes

is not unnecessarily restricted.

Standards of this nature intentionally avoid addressing more than the most basic elements regarding

the safety and performance of NFISs in humans. Any intended labelling of such devices indicating their

use to deliver medicinal products into the body or into specified tissue compartments 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 devices and pharmaceutical products. Such 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 dose chambers

designed for different NFISs, 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

dose chambers. This issue is left for future initiatives to build upon the standards promulgated herein.

The sampling plans for inspection selected for this document are intended to verify the design, at a

high confidence level, i.e. the manufacturer's ability to manufacture one “lot” of NFISs, which conforms

to the critical product attributes. 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.

This document is written with the understanding that each system will be verified and validated for

each therapeutic or medicinal product for which it is intended to be used. If the same system is able to,

with no or minimal changes, deliver more than one therapeutic or medicinal product, due to the nature

and uniqueness of the combination of the delivery system and therapeutic or medicinal product, it will

be considered another product and each combination shall be addressed individually according to the

requirements of this document. This does not preclude leveraging information and data across systems

as long as there is sufficient information to support the unique combination under development.

Manufacturers are expected to follow a risk-based approach during the design, development, and

manufacture of the NFIS. Given that each product may deliver different medicinal products and/or have

a different intended use, this can result in product-specific requirements and test methods that differ

from what is outlined in this document. It is expected that a risk management process is applied to

justify and document:

— any exclusions/deviations from requirements, specifications, methods or limits contained in

or referenced in this document when they are not directly applicable and/or appropriate to the

system. These new or modified requirements can be more or less restrictive as they are unique to

the specific NFIS (including the medicinal product); and

— any substitutions or omissions of requirements, specifications, methods or limits unique to each

specific NFIS (including the medicinal product), when those provided in this document are not

applicable and/or appropriate to the NFIS.

The flexibility provided in this document allows it to be applied to many different device and medicinal

product combinations. However, this makes it difficult to make a general declaration of conformance to

the document. As such, when making any declaration of conformance to this document, such deviations,

exclusions, substitutions, and omissions must be specified and supported by adequate justification in

the design file.
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oSIST prEN ISO 21649:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 21649:2022(E)
Needle-free injection systems for medical use —
Requirements and test methods
1 Scope

This document applies to safety and performance and testing requirements for single-use and multiple-

use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings

and for personal use by patients.

The dose chamber of the NFIS is often disposable and intended to be replaced after either a single

use or a limited number of uses. It is sometimes separable from the injection mechanism and often

termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber may also

incorporate a permanent internal chamber designed to last through the claimed life of the device, and

an additional member or members which eliminate the risk of cross-contamination.
Excluded from this document are drug delivery methods which:

— involve penetration of a part of the device itself into or through skin or mucous membranes (such as

needles, tines, micro-needles, implantable slow-release drug devices);

— generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal

or oral deposition (such as sprays, inhalers, misters);

— deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive

diffusion or ingestion into the body (such as transdermal patches, liquid drops);

— apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);

— infusion systems for adding or metering medication into or through systems of artificial tubes,

catheters, and/or needles which themselves enter the body.
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 7886-3:2020, Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose

immunization
ISO 10993 (all parts), — Biological evaluation of medical devices

ISO 11201, Acoustics — Noise emitted by machinery and equipment — Determination of emission sound

pressure levels at a work station and at other specified positions in an essentially free field over a reflecting

plane with negligible environmental corrections

ISO 11202, Acoustics — Noise emitted by machinery and equipment — Determination of emission sound

pressure levels at a work station and at other specified positions applying approximate environmental

corrections

ISO 11204, Acoustics — Noise emitted by machinery and equipment — Determination of emission sound

pressure levels at a work station and at other specified positions applying accurate environmental

corrections

ISO 14155-1, Clinical investigation of medical devices for human subjects — Good clinical practice

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ISO 14253-1, Geometrical product specifications (GPS) — Inspection by measurement of workpieces and

measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications

IEC 60068-2-27, Environmental testing — Part 2: Tests. Test Ea and guidance: Shock

IEC 60068-2-30:2005, Environmental testing — Part 2-30: Tests. Test Db and guidance: Damp heat, cyclic

(12 h + 12 h cycle)

IEC 60068-2-31, Environmental testing — Part 2-31: Tests. Test Ec: Rough handling shocks, primarily for

equipment-type specimens

IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broad-band random and

guidance
IEC 60529, Degrees of protection provided by enclosures (IP Code)

I EC 6 0721-3-7:19 95+A M D1: 19 96 , CSV (Consolidated version), Classification of environmental conditions —

Part 3-7: Classification of groups of environmental parameters and their severities — Portable and non-

stationary use

IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement

techniques — Electrostatic discharge immunity test

IEC 61000-4-3:2020, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement

techniques — Radiated, radio-frequency, electromagnetic field immunity test
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications

IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices

ISO/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in

measurement (GUM: 1995)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological 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
claimed lifetime

total number of injection strokes that a needle-free injection system (3.9), in normal use with

recommended user maintenance and before manufacturer overhaul or refurbishment of parts, is

expected to administer within its performance profile (3.12) specified by the manufacturer

Note 1 to entry: This number may also be expressed as a period of time (e.g. number of days, weeks, months or

years) at a corresponding frequency of expected usage (e.g. number of injections per day, week, month or year).

3.2
dose chamber

enclosure which contains and is in direct contact with the pharmaceutical product, and from which the

pharmaceutical product is administered to the patient by the NFIS
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oSIST prEN ISO 21649:2022
ISO/DIS 21649:2022(E)
3.3
dose indicator

component of a needle-free injection system (3.9) showing the intended dose (3.6) to be delivered

Note 1 to entry: Depending on the device design, such indication may or may not be apparent before the dose

chamber (3.2) is filled.
3.4
dose accuracy
difference between the intended dose and the delivered dose
3.5
injection mechanism

components of the needle-free injection system (3.9) which are designated to harness, store, regulate,

control and transfer to the dose chamber (3.2) and/or its contained medicinal product the energies

required for the injection to occur, including means to prevent release of such energies, such as a "safety

latch"

Note 1 to entry: This term is not used to refer to separate accessories which transfer energy into the NFIS but

which are separated from the NFIS at the time of the injection (such as a separate spring-cocking mechanism,

a gas pressurizing tank, a foot pump or other separate device using electricity, muscle power or other energy

source).
3.6
intended dose
amount (volume or mass) of medicinal product intended to be expelled at one time
3.7
maximum dose

volumes, masses or number of units representing the largest quantities, which the manufacturer

designates the needle-free injection system (3.9) is capable of expelling by one injection

3.8
minimum dose

volumes, masses or number of units representing the smallest quantities, which the manufacturer

designates the needle-free injection system (3.9) is capable of expelling by one injection

3.9
needle-free injection system
NFIS

injector and its components and accessories that administer a medicinal product to a patient by using

mechanical motion (such as movement of a piston or flow of a gas, but not to exclude other means) to

impart kinetic energy to the medicinal product, without any part of the system penetrating the skin or

mucous membranes
Note 1 to entry: Such components and accessories may include:
— disposable or re-usable dose chambers (3.2);

— separable mechanisms that obtain, transfer, convert, or store energy (using hydraulic, pneumatic, mechanical,

electrical, chemical or other means);

— filling devices to hold dose chambers (3.2) and feed them into the injector or vessels to capture and dispose of

used containers;
— instructions and educational materials for end-users.
3.10
nozzle
component of an injector through which the medicinal product is expelled

Note 1 to entry: The nozzle may or may not, depending on the device design, make physical contact with the skin

or other membranes of the patient.
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oSIST prEN ISO 21649:2022
ISO/DIS 21649:2022(E)
3.11
orifice

hole at the end of the nozzle (3.10), through which the medicinal product is expelled

3.12
performance profile

manufacturer-specified set of measurable and quantitative values and tolerance intervals which

describes the proper functioning of a needle-free injection system (3.9)
3.13
reservoir
intermediate enclosure that holds
...