SIST EN ISO 21649:2007

Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the injection system 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 also may be a permanent internal chamber designed to last through the claimed life of the device. Excluded from this International Standard 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 21649:2006)

Diese Internationale Norm gilt für die Sicherheits-, Leistungs  und Prüfanforderungen für kanülenlose Injektionssysteme 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 Injektionssystems 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 darf die Dosierkammer auch eine dauerhafte innere Kammer sein, die so ausgelegt ist, dass sie über die festgelegte Lebensdauer des Geräts haltbar ist.
Von dieser Internationalen Norm ausgeschlossen sind Verfahren zur Medikamentenabgabe, die:
-   mit einer Durchbohrung eines Teils des Geräts selbst in die oder durch Haut oder Schleimhäute einher gehen (wie Kanülen, Nadeln, Mikrokanülen, implantierbare Geräte zur langsamen Medikamenten-abgabe);
-   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.

Injecteurs sans aiguille a usage médical - Exigences et méthodes d'essai (ISO 21649:2006)

La présente partie de la série des EN 13795 spécifie les exigences de performance qui s’appliquent aux champs chirurgicaux, aux casaques et aux tenues de bloc.
NOTE   Les exigences de performance générales qui s’appliquent a différentes caractéristiques sont spécifiées dans les Tableaux 1 a 3 de l’EN 13795-1:2002. Il convient d’évaluer ces caractéristiques conformément a l’EN 13795-2, a l’EN ISO 22610 et a l’EN ISO 22612.

Injektorji brez igle za uporabo v medicini - Zahteve in preskusne metode (ISO 21649:2006)

General Information

• Status: Withdrawn
• Publication Date: 10-Sep-2007
• Withdrawal Date: 19-Nov-2009
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 20-Nov-2009
• Due Date: 13-Dec-2009
• Completion Date: 20-Nov-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 21649:2006 - Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

Relations

• Replaced By: SIST EN ISO 21649:2010 - Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
• Effective Date: 01-Jan-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21649:2007
01-oktober-2007
Injektorji brez igle za uporabo v medicini - Zahteve in preskusne metode (ISO
21649:2006)
Needle-free injectors for medical use - Requirements and test methods (ISO
21649:2006)
Kanülenlose Injektionsgeräte zur medizinischen Anwendung - Anforderungen und
Prüfverfahren (ISO 21649:2006)
Injecteurs sans aiguille a usage médical - Exigences et méthodes d'essai (ISO
21649:2006)
Ta slovenski standard je istoveten z: EN ISO 21649:2006
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 21649:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 21649
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.20

English Version
Needle-free injectors for medical use - Requirements and test
methods (ISO 21649:2006)
Injecteurs sans aiguille à usage médical - Exigences et Kanülenlose Injektionsgeräte zur medizinischen
méthodes d'essai (ISO 21649:2006) Anwendung - Anforderungen und Prüfverfahren (ISO
21649:2006)
This European Standard was approved by CEN on 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21649:2006: E
worldwide for CEN national Members.

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EN ISO 21649:2006 (E)





Foreword


This document (EN ISO 21649:2006) has been prepared by Technical Committee ISO/TC 84
"Medical devices for injections" in collaboration with CMC.

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 December 2006, and conflicting national
standards shall be withdrawn at the latest by December 2006.

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).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, 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.


Endorsement notice

The text of ISO 21649:2006 has been approved by CEN as EN ISO 21649:2006 without any
modifications.

2

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EN ISO 21649:2006 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC



This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC.

Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative 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

Clause(s)/sub-clause(s) of Essential Requirements (ERs) of EU Qualifying
this European Standard Directive 93/42/EEC remarks/Notes
5.1 7.1, 8.1, 8.3, 8.4, 12.7.3, 12.8.1, 12.8.2
5.3 12.8
5.4 10, 12.8, 12.9
5.5 1, 2, 3, 4, 6
5.6.1 4, 9.2, 10.1, 12.8.1
5.6.2 5
5.6.3 5
5.6.4 5
5.6.5 4, 12.7.1
5.6.6 4, 12.7.1, 12.7.2
5.6.7 9.2, 12.5
6.1, 6.2 1, 3, 4, 5 General conditions for
performing tests
6.2.2 4, 9.2
6.2.3 5
6.2.4 5
6.2.5 5
6.2.6 4, 9.1, 12.7.1
6.2.7 4, 9.2, 12.7.1
3

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EN ISO 21649:2006 (E)


Clause(s)/sub-clause(s) of Essential Requirements (ERs) of EU Qualifying
this European Standard Directive 93/42/EEC remarks/Notes
6.2.8 9.2
6.3 4, 5
6.4.1 3, 4, 12.8
6.4.2 3, 4, 5, 10.2, 12.9, 13.1, 13.2
7 All applicable ERs Report on tests
8.1 13.1
8.2 13.1, 13.3, 13.4, 13.5
8.3 13.6
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this European standard.

4

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INTERNATIONAL ISO
STANDARD 21649
First edition
2006-06-01


Needle-free injectors for medical use —
Requirements and test methods
Injecteurs sans aiguille à usage médical — Exigences et méthodes
d'essai




Reference number
ISO 21649:2006(E)
©
ISO 2006

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ISO 21649:2006(E)
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Published in Switzerland

ii © ISO 2006 – All rights reserved

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ISO 21649:2006(E)
Contents Page
Foreword. iv
Introduction . v
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 specification requirements . 6
5.4 Uncertainty of measurements and conformance with specifications. 7
5.5 Performance profile requirements. 7
5.6 Test requirements. 7
6 Test methods. 10
6.1 General. 10
6.2 Test procedures . 11
6.3 Test conditions . 18
6.4 Test evaluations. 19
7 Test report . 20
8 Information supplied by the manufacturer . 21
8.1 General. 21
8.2 Marking . 21
8.3 Instructions for use . 22
Annex A (informative) Two-sided tolerance limit factors (k). 23
Annex B (informative) Examples of accuracy limit calculations and random settings . 28
Annex C (informative) Correspondence between ISO/IEC standards and EN standards. 29
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC. 30
Bibliography . 32

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ISO 21649:2006(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 21649 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters.

iv © ISO 2006 – All rights reserved

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ISO 21649:2006(E)
Introduction
This International Standard applies to needle-free injectors primarily intended to administer medicinal products
to humans. Because of the anticipated variation in the designs of such a broad array of devices, this
International Standard 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 needle-free injector devices 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 needle-free 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 dose
chambers. This issue is left for future initiatives to build upon the standards promulgated herein.
The sampling plans for inspection selected for this International Standard are intended to verify the design, at
a high confidence level, i.e., the manufacturer's ability to manufacture one “lot” of needle-free injectors, 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.

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INTERNATIONAL STANDARD ISO 21649:2006(E)

Needle-free injectors for medical use — Requirements and test
methods
1 Scope
This International Standard applies to safety and performance and testing requirements for single-use and
multiple-use needle-free injection systems intended for human use in clinics and other medical settings and
for personal use by patients.
The dose chamber of the injection system 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 also may be a permanent
internal chamber designed to last through the claimed life of the device.
Excluded from this International Standard 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 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 3207:1975, Statistical interpretation of data — Determination of a statistical tolerance interval
ISO 3746:1995, Acoustics — Determination of sound power levels of noise sources using sound pressure —
Survey method using an enveloping measurement surface over a reflecting plane
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 11201:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission
sound pressure levels at a work station and at other specified positions — Engineering method in an
essentially free field over a reflecting plane
ISO 11202:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission
sound pressure levels at a work station and at other specified positions — Survey method in situ
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ISO 21649:2006(E)
ISO 11204:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission
sound pressure levels at a work station and at other specified positions — Method requiring environmental
corrections
ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General
requirements
ISO 14155-2:2003, Clinical investigation of medical devices for human subjects — Part 2: Clinical
investigation plans
ISO 14253-1:1998, Geometrical Product Specifications (GPS) — Inspection by measurement of workpieces
and measuring equipment — Part 1: Decision rules for proving conformance or non-conformance with
specifications
IEC 60068-2-27:1987, 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 60068-2-32:1975, Environmental testing — Part 2: Tests. Test Ed: Free fall
IEC 60068-2-64:1993, Environmental testing — Part 2: Test methods — Test Fh: Vibration, broad-band
random (digital control) and guidance
IEC 60601-1-1:2000, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral
standard: Safety requirements for medical electrical systems
IEC 60721-3-7:2002, Classification of environmental conditions — Part 3-7: Classification of groups of
environmental parameters and their severities — Portable and non-stationary use
IEC 61000-4-2:2001, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement
techniques — Electrostatic discharge immunity test
IEC 61000-4-3:2002, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement
techniques — Radiated, radio-frequency, electromagnetic field immunity test
IEC 61672-1:2002, Electroacoustics — Sound level meters — Part 1: Specifications
GUM:1995, Guide to the Expression of Uncertainty in Measurement (GUM). BIPM, IEC, IFCC, ISO, IUPAC,
IUPAP, OIML — First edition 1993, corrected and reprinted 1995
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
intended dose
amount (volume or mass) of medicinal product intended to be ejected at one time
3.2
ejected dose
amount (volume or mass) of medicinal product ejected at one time
3.3
dose specification
variation of dose quantities (volume or mass) — and a statistical summation of same — which the needle-free
injection system will eject for one or for a range of nominal dose quantities, as annunciated by the dose
indicator read by typical users of the device
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ISO 21649:2006(E)
3.4
dose chamber
final enclosure which holds the pharmaceutical product and has direct contact with it just prior to its
administration to the patient
3.5
dose indicator
component of a needle-free injection system showing the intended dose to be delivered
NOTE Depending on the device design, such indication may or may not be apparent before the dose chamber is
filled.
3.6
filling device
integral component or components of, or separate or separable accessory(ies) to, a needle-free injector which
acts or assists in the transfer of medicinal product between a reservoir and a dose chamber
NOTE Needle-free injection systems in which the dose chamber is or can be pre-filled by the manufacturer of the
medicinal product may function without any such filling device. When a filling device is required, it may be as simple as an
adapter providing an interface between medicinal reservoir and dose chamber, (e.g., using the piston and plunger of the
latter to effect the transfer), or be as complicated as a device with internal channels to actively withdraw and insert the
medicinal product from and to the respective containers.
3.7
injection mechanism
components of the needle-free injection system which are designated to harness, store, prevent (as in a
“safety” latch), trigger, regulate, control and transfer to the dose chamber and/or its contained medicinal
product the energies required for the injection to occur
NOTE This term is not used to refer to separate accessories which transfer energy into the needle-free injector but
which are separated from the needle-free injector 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).
3.8
claimed lifetime
total number of ejections that a needle-free injection system, in normal use with recommended user
maintenance and before manufacturer overhaul or refurbishment of parts, is expected to administer within its
performance profile specified by the manufacturer
NOTE 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).
3.9
maximum and minimum dose
volumes, masses or number of units representing the largest and smallest quantities, which the manufacturer
designates the needle-free injection system is capable of ejecting by one injection
3.10
reservoir
intermediate enclosure that holds and has contact with the medicinal product immediately prior to its transfer
into the dose chamber
NOTE This container is often the vial or other enclosure filled with the medicinal product by the pharmaceutical
manufacturer (and termed the “primary packaging” in that industry). It may be single-dose or multi-dose, and usually
requires some manipulation by the user, by an accessory filling device, or by the injector device itself to transfer the
contents into the dose chamber. There may be no medicinal reservoir for those needle-free injection systems in which the
dose chamber is pre-filled by the manufacturer of the medicinal product.
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ISO 21649:2006(E)
3.11
needle-free injection system
needle-free injector and its components and accessories that administer a medicinal product, without any part
of the system penetrating the skin or mucous membranes
NOTE Such components and accessories may include:
⎯ disposable or re-usable dose chambers;
⎯ separable mechanisms that obtain, transfer, convert, or store energy (using hydraulic, pneumatic, mechanical,
electrical, chemical or other means);
⎯ filling devices to hold dose chambers and feed them into the injector or vessels to capture and dispose of used
containers;
⎯ instructions and educational materials for end-users.
3.12
needle-free injector
device that administers 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
3.13
nozzle
component of an injector through which the medicinal product is ejected
NOTE The nozzle may or may not — depending on the device design — make physical contact with the skin or other
membranes of the patient.
3.14
orifice
hole at the end of the nozzle, through which the medicinal product is expelled
3.15
performance profile
manufacturer-specified set of measurable and quantitative values and tolerance intervals which describes the
proper functioning of a needle-free injection system
3.16
replicate
random sequence of V , V , and V
min mid max
3.17
unit container
customer packaging of an individual component or needle-free injection system
4 Symbols and abbreviated terms
V One of the 3 pre-set doses (expressed as a volume in millilitres) used in determining the uncertainty of
set
dose for a given needle-free injector. V is defined as one of the following:
set
a) minimum dose (V = V ) (specified in the instructions for use);
set min
b) maximum dose (V = V ) (specified in the instructions for use);
set max
c) midpoint dose (V = V ) where V is defined as the injector setting closest to (V + V )/2.
set mid mid min max
NOTE Recommended doses as specified in the instruction for use may differ from those doses that can be
set.
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ISO 21649:2006(E)
V The volumetric measurement value for a given V ;
meas set
G The gravimetric measurement value for a given V ;
meas set
ρ Mass density expressed in grams per millilitre;
p Probability content;
n Number of needle-free injectors required for a given test;
x The sample average (based on a random sample), an estimate of the population average:
x = ΣV /n;
meas
s The sample standard deviation (based on a random sample), an estimate of the population standard
deviation:
2
Vx−
()
∑ meas
s=
n−1
k Tolerance Limit Factor; determined from the confidence level, probability content, p, and the number of
measurements, n, conducted at each dose setting;
TP The transition point in millilitres; the volume at which the definition of the upper and lower specification
limit for V changes from absolute terms to relative terms:
set
TP = 0,2 ml;
USL Upper Specification Limit for a given V ;
set
LSL Lower Specification Limit for a given V .
set
5 Requirements
5.1 General requirements
When the needle-free injector is ready for injection, there is an indication to the user that the intended dose of
medicinal product is present to be delivered. The needle-free injector shall indicate the dose to be delivered.
The needle-free injector shall indicate, at least by visual means, that the device is ready for injection.
After the injection, the needle-free injector shall indicate, by visual or auditory or tactile means, that the
intended dose has been expelled.
The state of the needle-free injector, when ready to deliver the dose, shall be visibly different from its state
when the dose has been delivered. For multi-dose needle-free injectors, the device shall be designed so it is
impossible to deliver a second dose after delivery of the first dose without a second and different operation.
The needle-free injector shall be designed to prevent or to reduce the risk of premature or inadvertent
actuation of the device, and/or to prevent or mitigate any injury that might result.
The materials used in the medicinal product or test fluid path (as appropriate) and any device component
likely to be in direct or indirect contact with body tissues (at the injection site) shall be demonstrated to be
biocompatible in accordance with ISO 10993-1 and other relevant parts of ISO 10993.
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ISO 21649:2006(E)
Devices with an exposed nozzle orifice, within reach of fingertips or environmental surfaces during preparation
of the device for use or upon setting it down, shall be equipped with a method of reducing the possibility of
contact of the orifice and nozzle face with environmental surfaces between the time
...