FprEN ISO 11608-5
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/FDIS 11608-5:2021)
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/FDIS 11608-5:2021)
This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).
General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:
a) medicinal product preparation (e.g. reconstitution);
b) needle preparation;
c) needle hiding;
d) priming;
e) dose setting;
f) needle insertion;
g) injection depth control;
h) injection of the medicinal product;
i) recording of device functions;
NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto).
j) disabling the NIS-AUTO;
k) needle retraction;
l) needle shielding;
m) needle removal.
All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO/FDIS 11608-5:2021)
Dieses Dokument legt Anforderungen an und Prüfverfahren für kanülenbasierte Injektionssysteme mit automatisierten Funktionen (NIS AUTOs) fest, die Folgendes umfassen, jedoch nicht allein darauf beschränkt sind:
a) Arzneimittelzubereitung (z. B. Rekonstitution);
b) Vorbereitung der Kanüle;
c) Verdeckung (Sichtschutz) der Injektionskanüle;
d) Betriebsbereitmachen;
e) Einstellen der Dosis;
f) Einführen der Kanüle;
g) Steuerung der Injektionstiefe;
h) Injizieren des Arzneimittels;
i) Aufzeichnung;
j) Deaktivieren des NIS AUTO;
k) Einziehen der Kanüle;
l) Schutzschild der Kanüle;
m) Entfernen der Kanüle.
Dieses Dokument behandelt keine Fernkommunikationsfunktionen von NIS AUTOs.
Automatisierte Funktionen, die nicht in der obigen Liste aufgeführt sind, müssen nach den in diesem Dokument dargestellten Grundsätzen spezifiziert und geprüft werden.
Alle Verweisungen auf „Funktion“ in diesem Dokument sind laut Definition als automatisierte Funktion auszulegen (siehe 3.2). Dieses Dokument gilt nicht für diese Funktionen, wenn sie durch den Benutzer manuell ausgeführt werden.
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO/FDIS 11608-5:2021)
Le présent document spécifie les exigences et les méthodes d'essai applicables aux fonctions automatisées des dispositifs d'injection à aiguille (NIS) disposant de fonctions automatisées (NIS-AUTO).
Des exigences générales sont spécifiées pour l'ensemble des fonctions automatisées. En outre, des exigences spécifiques sont définies pour les fonctions automatisées suivantes:
a) la préparation des produits médicaux (par exemple, reconstitution);
b) la préparation de l'aiguille;
c) le masquage d'aiguille;
d) l'amorçage;
e) le réglage de la dose;
f) l'insertion de l'aiguille;
g) la vérification de la profondeur d'injection;
h) l'injection du produit médical;
i) l'enregistrement des fonctions du dispositif;
NOTE Le présent document ne couvre pas la communication à distance émanant du NIS-AUTO (qui concerne le transfert de communication avec ou sans fil du NIS-AUTO).
j) la désactivation du NIS-AUTO;
k) le retrait de l'aiguille;
l) la couverture d'aiguille;
m) le démontage de l'aiguille.
Toute référence faite à une «fonction» dans le cadre du présent document est, par définition, considérée comme une fonction automatisée (voir 3.2). Le présent document ne s'applique pas aux fonctions exécutées manuellement par l'utilisateur.
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del: Avtomatizirane funkcije (ISO/DIS 11608-5:2020)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2020
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del:
Avtomatizirane funkcije (ISO/DIS 11608-5:2020)
Needle-based injection systems for medical use - Requirements and test methods - Part
5: Automated functions (ISO/DIS 11608-5:2020)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO/DIS 11608-5:2020)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 5: Fonctions automatisées (ISO/DIS 11608-5:2020)
Ta slovenski standard je istoveten z: prEN ISO 11608-5
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-5
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2020-02-18 2020-05-12
Needle-based injection systems for medical use —
Requirements and test methods —
Part 5:
Automated functions
Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai —
Partie 5: Fonctions automatisées
ICS: 11.040.25
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
ISO/DIS 11608-5:2020(E)
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ISO/DIS 11608-5:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 4
4.1 General requirements . 4
4.2 Medicinal product preparation . 5
4.3 Needle preparation . 5
4.4 Needle hiding. 6
4.5 Priming . 6
4.6 Dose setting . 6
4.7 Needle insertion . 6
4.8 Injection depth control . 6
4.9 Dose delivery . 6
4.10 Device function information. 6
4.11 Needle retraction . 6
4.11.1 Completion of dose delivery . 6
4.11.2 Needle retraction distance . 7
4.11.3 Communication of completion . 7
4.12 Disabling the NIS-AUTO . 7
4.13 Needle shielding . 7
4.13.1 General. 7
4.13.2 Needle shielding before injection . 7
4.13.3 Needle shielding after injection . 7
4.14 Needle removal from the NIS-AUTO . 8
5 Test methods . 8
5.1 General . 8
5.2 Test conditions . 8
5.3 Actuation . 8
5.4 Medicinal product preparation . 8
5.5 Needle inspection . 8
5.6 Needle hiding. 9
5.7 Priming . 9
5.8 Needle extension .10
5.9 Injection time .10
5.10 Dose accuracy .10
5.11 Retracted position .10
5.12 Disabling the NIS-AUTO .10
5.13 Needle shielding .11
5.13.1 Needle shielding before and after injection .11
5.13.2 Needle shielding after free fall .11
6 Information to be supplied by the manufacturer .11
Annex A (informative) Rationale for requirements .12
Annex B (informative) Example of a test method for dose accuracy at intended injection depth .14
Annex C (informative) Needle extension and intended injection depth .16
Bibliography .21
ISO/DIS 11608-5:2020(E)
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This document was prepared by ISO/TC 84 Devices for administration of medicinal products and
catheters.
This second edition cancels and replaces the first edition (ISO 11608-5:2012), which has been
technically revised.
Information about the revision history of the ISO 11608 series can be found in ISO 11608-1:20##.
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