EN ISO 11608-5:2023

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)

Dieses Dokument legt Anforderungen an und Prüfverfahren für automatisierte Funktionen in kanülenbasierten Injektionssystemen mit automatisierten Funktionen (NIS AUTOs) fest.
Für alle automatisierten Funktionen werden allgemeine Anforderungen bereitgestellt. Darüber hinaus werden spezifische allgemeine Anforderungen für die folgenden automatisierten Funktionen bereitgestellt:
a)   Arzneimittelzubereitung (z. B. Rekonstitution);
b)   Vorbereitung der Kanüle;
c)   Kanülenverdeckung;
d)   Betriebsbereitmachen;
e)   Einstellen der Dosis;
f)   Einführen der Kanüle;
g)   Steuerung der Injektionstiefe;
h)   Injizieren des Arzneimittels;
i)   Aufzeichnung der Gerätefunktionen;
ANMERKUNG   Dieses Dokument behandelt keine Fernkommunikationsfunktionen von NIS AUTOs (bezieht sich auf die drahtgebundene und drahtlose Kommunikationsübertragung von dem NIS AUTO).
j)   Deaktivieren des NIS AUTO;
k)   Einziehen der Kanüle;
l)   Abschirmung der Kanüle;
m)   Entfernen der Kanüle.
Alle Verweisungen auf „Funktion“ in diesem Dokument werden laut Definition als automatisierte Funktion ausgelegt (siehe 3.2). Dieses Dokument ist nicht anwendbar für Funktionen, die vom Benutzer manuell ausgeführt werden.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO 11608-5:2022)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del: Avtomatizirane funkcije (ISO 11608-5:2022)

Ta del standarda ISO 11608 določa zahteve in preskusne metode za avtomatizirane funkcije peres za injiciranje (navedene v standardu kot NIS-AUTO), ki so namenjene dajanju zdravil ljudem. Ta dokument ne obravnava oddaljene komunikacije iz NIS-AUTO.

General Information

• Status: Published
• Publication Date: 21-Mar-2023
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 22-Mar-2023
• Due Date: 30-Nov-2024
• Completion Date: 22-Mar-2023
• Ref Project: SIST EN ISO 11608-5:2023 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

Relations

• Replaces: EN ISO 11608-5:2012 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2023
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del:
Avtomatizirane funkcije (ISO 11608-5:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part
5: Automated functions (ISO 11608-5:2022)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 5: Fonctions automatisées (ISO 11608-5:2022)
Ta slovenski standard je istoveten z: EN ISO 11608-5:2023
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.

EN ISO 11608-5
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2023
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-5:2012
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 5: Automated
functions (ISO 11608-5:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 5: Fonctions Verwendung - Anforderungen und Prüfverfahren - Teil
automatisées (ISO 11608-5:2022) 5: Automatisierte Funktionen (ISO 11608-5:2022)
This European Standard was approved by CEN on 10 March 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 11608-5:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 11608-5:2022 has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 11608-5:2023 by Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
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 September 2023, and conflicting national standards
shall be withdrawn at the latest by September 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 11608-5:2012.
Any feedback and questions on this document should be directed to the users’ national standards body.
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 11608-5:2022 has been approved by CEN as EN ISO 11608-5:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-5
Second edition
2022-04
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
Reference number
ISO 11608-5:2022(E)
ISO 11608-5:2022(E)
© ISO 2022
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11608-5:2022(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 . 6
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 . 7
4.10 Recording of device functions . 7
4.11 Needle retraction . 7
4.11.1 Completion of dose delivery . 7
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 . 8
4.13.1 General . 8
4.13.2 Needle shielding before injection . 8
4.13.3 Needle shielding after injection . 8
4.14 Needle removal from the NIS-AUTO . 8
5 Test methods . 8
5.1 General . 8
5.2 Test conditions . 9
5.3 Actuation . 9
5.4 Medicinal product preparation . 9
5.5 Needle inspection . 9
5.6 Needle hiding . 9
5.7 Priming . 10
5.8 Needle extension . 10
5.9 Injection time . 10
5.10 Dose accuracy . 11
5.11 Retracted position . 11
5.12 Disabling the NIS-AUTO. 11
5.13 Needle shielding . 11
5.13.1 Needle shielding before and after injection . 11
5.13.2 Needle shielding after free fall.
...