SIST EN ISO 21649:2010
(Main)Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
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 à 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 à différentes caractéristiques sont spécifiées dans les Tableaux 1 à 3 de l’EN 13795-1:2002. Il convient d’évaluer ces caractéristiques conformément à l’EN 13795-2, à l’EN ISO 22610 et à l’EN ISO 22612.
Injektorji brez igle za uporabo v medicini - Zahteve in preskusne metode (ISO 21649:2006)
Ta mednarodni standard velja za zahteve za varnost in delovanje ter preskušanje injektorskih sistemov brez igle za enkratno in večkratno uporabo, namenjenih ljudem na klinikah in drugih zdravstvenih okoljih ter osebni uporabi bolnikov. Odmerna komora injektorskega sistema je pogosto namenjena enkratni uporabi in se zamenja po enkratni uporabi ali po omejenem številu uporab. Včasih se lahko loči od injektorskega mehanizma in se pogosto imenuje »kaseta«, »ampula«, »injekcijska brizga«, »kapsula« ali »disk«. Odmerna komora pa je lahko tudi trajna notranja komora, ki mora zdržati navedeno življenjsko dobo pripomočka. Iz tega mednarodnega standarda so izločene metode za dovajanje zdravila, ki: - vključujejo prediranje dela pripomočka v ali skozi kožo ali sluznico (kot so igle, konice, mikro igle, vsaditveni pripomočki za počasno sproščanje zdravila); - proizvajajo aerosole, kapljice, praške ali druge pripravke za inhalacijo, insuflacijo, intranazalni ali peroralni nanos (kot so razpršila, inhalatorji, vlažilniki); - nanašajo tekočine, praške ali druge snovi na površino kože ali sluznico za pasivno razprševanje ali zaužitje v telo (kot so transdermalni obliži, kapljice); - vnašajo zvočno ali elektromagnetno energijo (kot so ultrazvočni ali iontoforezni pripomočki); - infuzijski sistemi za dodajanje ali odmerjanje zdravila v ali skozi sistem umetnih cevk, katetrov in/ali igel, ki sami vstopajo v telo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21649:2010
01-januar-2010
1DGRPHãþD
SIST EN ISO 21649:2007
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 à usage médical - Exigences et méthodes d'essai (ISO
21649:2006)
Ta slovenski standard je istoveten z: EN ISO 21649:2009
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 21649:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 21649:2010
---------------------- Page: 2 ----------------------
SIST EN ISO 21649:2010
EUROPEAN STANDARD
EN ISO 21649
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2009
ICS 11.040.20 Supersedes EN ISO 21649:2006
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 24 August 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21649:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 21649:2010
EN ISO 21649:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 21649:2010
EN ISO 21649:2009 (E)
Foreword
The text of ISO 21649:2006 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 21649:2009.
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 March 2010, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 supersedes EN ISO 21649:2006.
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.
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 organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, 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 the United Kingdom.
Endorsement notice
The text of ISO 21649:2006 has been approved by CEN as a EN ISO 21649:2009 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 21649:2010
EN ISO 21649:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU 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)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 93/42/EEC
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, 6 a Ergonomic requirements in ERs
1 are only partly covered in
th
standard by subclauses 5.1 7
paragraph and 5.5.2 Note
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.
Ergonomic requirements in ERs
1 are only partly covered in
th
standard by subclauses 5.1 7
paragraph and 5.5.2 Note
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
4
---------------------- Page: 6 ----------------------
SIST EN ISO 21649:2010
EN ISO 21649:2009 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6.2.7 4, 9.2, 12.7.1
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 Except 13.3 (f) (regarding
indication of single-use and
consistent across community)
and 13.3(a) (regarding
representative in the
Community)
8.3 13.6 Except 13.6 (h) (regarding if the
device bears indication of single
use, information on known
characteristics and technical
factors known to manufacturer
that could pose a risk if reused)
and 13.6 (q) (regarding date of
issue or latest revision of
instructions for use)
NOTE 12.1 a Software requirements are not
covered in this standard
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 21649:2010
---------------------- Page: 8 ----------------------
SIST EN ISO 21649:2010
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
---------------------- Page: 9 ----------------------
SIST EN ISO 21649:2010
ISO 21649:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 21649:2010
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
© ISO 2006 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 21649:2010
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
---------------------- Page: 12 ----------------------
SIST EN ISO 21649:2010
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.
© ISO 2006 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 21649:2010
---------------------- Page: 14 ----------------------
SIST EN ISO 21649:2010
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
© ISO 2006 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 21649:2010
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
2 © ISO 2006 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 21649:2010
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.
© ISO 2006 – All rights reserved 3
---------------------- Page: 17 ----------------------
SIST EN ISO 21649:2010
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.
4 © ISO 2006 – All rights reserved
---------------------- Page: 18 ----------------------
SIST EN ISO 21649:2010
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 sam
...
SLOVENSKI STANDARD
kSIST FprEN ISO 21649:2009
01-julij-2009
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 à usage médical - Exigences et méthodes d'essai (ISO
21649:2006)
Ta slovenski standard je istoveten z: FprEN ISO 21649
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
kSIST FprEN ISO 21649:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST FprEN ISO 21649:2009
---------------------- Page: 2 ----------------------
kSIST FprEN ISO 21649:2009
EUROPEAN STANDARD
FINAL DRAFT
FprEN ISO 21649
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.20 Will supersede EN ISO 21649:2006
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 draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/SS S03.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN ISO 21649:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
kSIST FprEN ISO 21649:2009
FprEN ISO 21649:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices .4
2
---------------------- Page: 4 ----------------------
kSIST FprEN ISO 21649:2009
FprEN ISO 21649:2009 (E)
Foreword
The text of ISO 21649:2006 has been prepared by Technical Committee ISO/TC 84 “Medical devices for
injections” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO
21649:2009 by Technical Committee CEN/SS S03 “Syringes” the secretariat of which is held by CMC.
This document is currently submitted to the Unique Acceptance Procedure.
This document will supersede EN ISO 21649:2006.
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 EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
Endorsement notice
The text of ISO 21649:2006 has been approved by CEN as a FprEN ISO 21649:2009 without any
modification.
3
---------------------- Page: 5 ----------------------
kSIST FprEN ISO 21649:2009
FprEN ISO 21649:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EC Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities 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)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
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, 6 a Ergonomic requirements in ERs
1 are only partly covered in
th
standard by subclauses 5.1 7
paragraph and 5.5.2 Note
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.
Ergonomic requirements in ERs
1 are only partly covered in
th
standard by subclauses 5.1 7
paragraph and 5.5.2 Note
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
4
---------------------- Page: 6 ----------------------
kSIST FprEN ISO 21649:2009
FprEN ISO 21649:2009 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
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 Except 13.3 (f) (regarding
indication of single-use and
consistent across community)
and 13.3(a) (regarding
representative in the
Community)
8.3 13.6 Except 13.6 (h) (regarding if the
device bears indication of single
use, information on known
characteristics and technical
factors known to manufacturer
that could pose a risk if reused)
and 13.6 (q) (regarding date of
issue or latest revision of
instructions for use)
NOTE 12.1 a Software requirements are not
covered in this standard
WARNING — Other requirements and other EC Directives may be applicable to the product(s) falling within
the scope of this standard.
5
---------------------- Page: 7 ----------------------
kSIST FprEN ISO 21649:2009
---------------------- Page: 8 ----------------------
kSIST FprEN ISO 21649:2009
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
---------------------- Page: 9 ----------------------
kSIST FprEN ISO 21649:2009
ISO 21649:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 10 ----------------------
kSIST FprEN ISO 21649:2009
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
© ISO 2006 – All rights reserved iii
---------------------- Page: 11 ----------------------
kSIST FprEN ISO 21649:2009
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
---------------------- Page: 12 ----------------------
kSIST FprEN ISO 21649:2009
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.
© ISO 2006 – All rights reserved v
---------------------- Page: 13 ----------------------
kSIST FprEN ISO 21649:2009
---------------------- Page: 14 ----------------------
kSIST FprEN ISO 21649:2009
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
© ISO 2006 – All rights reserved 1
---------------------- Page: 15 ----------------------
kSIST FprEN ISO 21649:2009
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
2 © ISO 2006 – All rights reserved
---------------------- Page: 16 ----------------------
kSIST FprEN ISO 21649:2009
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.
© ISO 2006 – All rights reserved 3
---------------------- Page: 17 ----------------------
kSIST FprEN ISO 21649:2009
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.
4 © ISO 2006 – All rights reserved
---------------------- Page: 18 ----------------------
kSIST FprEN ISO 21649:2009
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.