EN ISO 21649:2006

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

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.

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.
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
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.

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
ISO 21649:2006(E)
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ii © ISO 2006 – All rights reserved

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 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

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 pharmaceutic
...