EN ISO 21649:2023
(Main)Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.
The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.
Excluded from this document are drug delivery methods which:
— involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);
— generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);
— deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);
— apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);
— infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.
Kanülenlose Injektionsgeräte zur medizinischen Anwendung - Anforderungen und Prüfverfahren (ISO 21649:2023)
Dieses Dokument ist anwendbar für die Sicherheits-, Leistungs- und Prüfanforderungen für kanülenlose Injek
tionssysteme(NFIS) zum Einmalgebrauch und zur Wiederverwendung, die für die Anwendung am Menschen in Kliniken und anderen medizinischen Einrichtungen sowie für die persönliche Anwendung durch Patienten vorgesehen sind.
Die Dosierkammer des NFIS ist oft ein Wegwerfartikel und dafür vorgesehen, nach einem einzigen Gebrauch oder einer begrenzten Anzahl von Verwendungen ersetzt zu werden. Sie ist manchmal vom Injektionsmecha
nismus abnehmbar und wird oft als „Patrone“, „Ampulle“, „Spritze“, „Kapsel“ oder „Scheibe“ bezeichnet. Im Gegensatz dazu kann die Dosierkammer auch eine dauerhafte innere Kammer, die so ausgelegt ist, dass sie über die festgelegte Lebensdauer des Geräts haltbar ist, sowie ein zusätzliches oder mehrere zusätzliche Teile, die das Risiko der Kreuzkontamination ausschließen, enthalten.
Von diesem Dokument ausgeschlossen sind Verfahren zur Medikamentenabgabe, die:
—
mit einer Durchbohrung eines Teils des Geräts selbst in die oder durch die Haut oder Schleimhäute einher gehen (wie Kanülen, Nadeln, Mikrokanülen, implantierbare Geräte zur langsamen Medikamentenabgabe);
—
Aerosole, Tröpfchen, Pulver oder andere Rezepturen für die Inhalation, das Einblasen oder die Ablagerung im Nasen- und Mundbereich erzeugen (wie Sprays, Inhalatoren, Vernebler);
—
Flüssigkeiten, Pulver oder andere Substanzen auf der Oberfläche von Haut oder Schleimhäuten zur passi
ven 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 künstli
cher Schläuche, Katheter und/oder Kanülen sind, die in den Körper eintreten.
Systèmes d'injection sans aiguille pour usage médical - Exigences et méthodes d'essai (ISO 21649:2023)
Le présent document s'applique aux exigences de sécurité, de performance et d'essai relatives aux systèmes d'injection sans aiguille (NFIS), à usage unique et réutilisables, destinés à être utilisés sur des êtres humains dans des cliniques et autres établissements médicaux, ou à l'usage personnel des patients.
La chambre à dose du NFIS 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». Mais, elle peut également comporter une chambre interne permanente conçue pour être utilisée pendant la durée de vie revendiquée du dispositif, et un ou plusieurs éléments supplémentaires qui éliminent le risque de contamination croisée.
Les méthodes d'administration de médicaments exclues du présent document sont celles qui:
— impliquent la pénétration d'une partie du dispositif proprement dit dans ou à travers la peau ou les muqueuses (comme les aiguilles, les dents, les micro aiguilles, les dispositifs médicaux implantables à libération prolongée);
— génèrent des aérosols, des gouttelettes, des poudres ou d'autres formulations destinées à une inhalation, une insufflation ou à une pulvérisation orale ou intranasale (comme les sprays, les inhalateurs, les nébulisateurs);
— déposent des liquides, des poudres ou d'autres substances à la surface de la peau ou des muqueuses pour une diffusion passive ou ingestion dans le corps (comme les timbres transdermiques, les gouttes liquides);
— appliquent une énergie sonique ou électromagnétique (comme les dispositifs à ultrasons ou iontophorétiques);
— permettent d'ajouter ou de doser le médicament (systèmes de perfusion) dans ou à travers des systèmes ou des tubes artificiels, des cathéters et/ou des aiguilles qui pénètrent eux-mêmes le corps.
Injektorji brez igle za uporabo v medicini - Zahteve in preskusne metode (ISO 21649:2023)
Ta dokument se uporablja za varnost in učinkovitost in zahteve glede preskušanja sistemov za injiciranje brez peres (NFIS) za enkratno in večkratno uporabo, ki so namenjeni za uporabo pri ljudeh v klinikah ali in drugih zdravstvenih okoljih in za osebno uporabo pri bolnikih.
Dozirna posoda sistema NFIS je pogosto namenjena enkratni uporabi in se zamenja po eni uporabi oziroma omejenem številu uporab. Včasih jo je mogoče ločiti od mehanizma za injiciranje in jo pogosto imenujemo »kartuša«, »ampula«, »brizga«, »kapsula« ali »disk«. Dozirna posoda lahko namreč vključuje tudi stalno notranjo posodo, zasnovano za uporabo v celotni življenjski dobi naprave, in dodatni element ali elemente, ki odpravljajo tveganje navzkrižne kontaminacije.
Ta dokument ne zajema metod za dajanje zdravil, ki:
– vključujejo penetracijo dela same naprave v ali skozi kožo ali sluznico (npr. igle, zobci, mikro igle, vsadne naprave za počasno sproščanje zdravila);
– ustvarjajo aerosole, kapljice, praške ali druge oblike za vdihavanje, vpihavanje, nosno ali ustno odmerjanje (npr. pršila, inhalatorji, naprave za ustvarjanje meglice);
– odlagajo tekočine, praške ali druge snovi na površino kože ali sluznice za pasivno difuzijo ali vpijanje v telo (npr. transdermalni obliži, tekočinske kapljice);
– uporabljajo zvočno ali elektromagnetno energijo (npr. ultrazvočne ali iontoforetične naprave);
– uporabljajo infuzijske sisteme za dodajanje ali odmerjanje zdravila v ali prek sistemov umetnih cevk, katetrov in/ali igel, ki vstopajo v telo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Nadomešča:
SIST EN ISO 21649:2010
Injektorji brez igle za uporabo v medicini - Zahteve in preskusne metode (ISO
21649:2023)
Needle-free injection systems for medical use - Requirements and test methods (ISO
21649:2023)
Kanülenlose Injektionsgeräte zur medizinischen Anwendung - Anforderungen und
Prüfverfahren (ISO 21649:2023)
Systèmes d'injection sans aiguille pour usage médical - Exigences et méthodes d'essai
(ISO 21649:2023)
Ta slovenski standard je istoveten z: EN ISO 21649:2023
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.
EN ISO 21649
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2023
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 21649:2009
English Version
Needle-free injection systems for medical use -
Requirements and test methods (ISO 21649:2023)
Systèmes d'injection sans aiguille pour usage médical - Kanülenlose Injektionsgeräte zur medizinischen
Exigences et méthodes d'essai (ISO 21649:2023) Anwendung - Anforderungen und Prüfverfahren (ISO
21649:2023)
This European Standard was approved by CEN on 23 January 2023.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21649:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 21649:2023) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and catheters" in collaboration with Technical Committee
CEN/SS S03 “Syringes” the secretariat of which is held by CCMC.
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 August 2023, and conflicting national standards shall
be withdrawn at the latest by August 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21649:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 21649:2023 has been approved by CEN as EN ISO 21649:2023 without any modification.
INTERNATIONAL ISO
STANDARD 21649
Second edition
2023-01
Needle-free injection systems for
medical use — Requirements and test
methods
Systèmes d'injection sans aiguille pour usage médical — Exigences et
méthodes d'essai
Reference number
ISO 21649:2023(E)
ISO 21649:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
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Published in Switzerland
ii
ISO 21649:2023(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols . 4
5 Requirements . 5
5.1 General requirements . 5
5.2 Noise requirements . 6
5.3 Dose accuracy specification requirements . 7
5.4 Usability engineering . . 7
5.5 Risk approach . 7
5.6 Uncertainty of measurements and conformance with specifications . 7
5.7 Performance profile requirements . 8
5.8 Test requirements. 8
5.8.1 NFISs subjected to standard, cool and hot atmospheres and after claimed
lifetime testing (in-use conditions) . 8
5.8.2 Dry heat storage - Preconditioning . 9
5.8.3 Damp heat storage – Preconditioning . 9
5.8.4 Cold storage - Preconditioning . 9
5.8.5 Cyclical testing - Preconditioning . 10
5.8.6 Free fall - Preconditioning . 10
5.8.7 Vibration and shock – Preconditioning . 10
5.8.8 Transport – Preconditioning . 10
5.8.9 NFISs with electrical components subjected to electromagnetic
compatibility (EMC) . 11
5.8.10 Water and dust resistance . 11
5.8.11 Auto-disable feature . 11
6 Test methods .12
6.1 General .12
6.2 Test procedures . 13
6.2.1 General .13
6.2.2 NFISs subjected to standard, cool and hot atmospheres and claimed
lifetime test . 14
6.2.3 NFISs subjected to dry heat storage atmosphere . 16
6.2.4 NFISs subjected to damp-heat storage atmosphere . 16
6.2.5 NFISs subjected to cold storage atmosphere . 17
6.2.6 NFISs subjected to a cyclical atmosphere . 17
6.2.7 NFISs subjected to free fall . 17
6.2.8 NFISs subjected to vibration and shock . . 18
6.2.9 NFISs with electrical components subjected to electromagnetic
compatibility (EMC) testing . 19
6.2.10 Noise testing .20
6.2.11 Water and dust resistance . 21
6.2.12 Auto-disable feature .22
6.3 Test evaluations . 22
6.3.1 Dose accuracy .22
6.3.2 Inspection .23
7 Test report .24
8 Information supplied with the NFIS .24
8.1 Genera
...
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