EN ISO 21649:2009
(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)
ISO 21649:2006 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.
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 Medikamentenabgabe);
⎯ Aerosole, Tröpfchen, Pulver oder andere Rezepturen für die Inhalation, das Einblasen oder die
Ablagerung im Nasen- und Mundbereich erzeugen (wie Sprays, Inhalatoren, Vernebler);
⎯ Flüssigkeiten, Pulver oder andere Substanzen auf der Oberfläche von Haut oder Schleimhäuten zur
passiven Diffusion oder Aufnahme in den Körper ablagern (wie Transkutanpflaster, Flüssigkeitstropfen);
⎯ Schall- oder elektromagnetische Energie anwenden (wie Ultraschall- oder Iontophoresegeräte);
⎯ Infusionssysteme zur Verabreichung oder Dosierung von Medikamenten in oder durch Systeme künstlicher
Schläuche, Katheter und/oder Kanülen sind, die in den Körper eintreten.
Injecteurs sans aiguille à usage médical - Exigences et méthodes d'essai (ISO 21649:2006)
L'ISO 21649:2006 s'applique aux exigences de sécurité, de performance et d'essai relatives aux systèmes d'injection sans aiguille à usage unique et réutilisables destinés à être utilisés sur des êtres humains dans des cliniques et autres établissements médicaux ou par les patients eux-mêmes.
La chambre à dose du système d'injection est souvent jetable et destinée à être remplacée après un usage unique ou un nombre limité d'utilisations Elle est parfois distincte du mécanisme d'injection et est souvent appelée «cartouche», «ampoule», «seringue», «capsule» ou «disque». À l'opposé, la chambre à dose peut aussi être une chambre interne permanente conçue pour durer le temps de la durée de vie déclarée du dispositif.
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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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
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.
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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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 al
...
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