EN ISO 11608-4:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022, Corrected version 2024-12)

This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).
This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document does not specify requirements for software in programmable NIS-E.
NOTE       IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO 11608-4:2022, korrigierte Fassung 2024-12)

Dieses Dokument legt Anforderungen und Prüfverfahren für kanülenbasierte Injektionssysteme (NISs, en: needle-based injection systems) fest, die elektronische Bauteile (mit oder ohne Software) enthalten (NIS Es).
Die kanülenbasierten Injektionssysteme, die elektronische Bauteile enthalten, können zum einmaligen Gebrauch bestimmt oder wiederverwendbar sein und können mit oder ohne elektrische/leitfähige Verbindungen zu anderen Geräten betrieben werden. Das System ist dafür vorgesehen, ein Arzneimittel durch Eigenanwendung oder durch einen anderen Bediener (z. B. Pflegekraft oder Gesundheitsdienstleister) an einen Patienten abzugeben bzw. zu verabreichen.
Dieses Dokument ist anzuwenden für elektronische Zubehörteile, die zur physischen Verbindung mit einem NIS oder NIS E entsprechend der bestimmungsgemäßen Verwendung des NIS/NIS E vorgesehen sind.
Dieses Dokument ist außerdem anzuwenden für elektronische Zubehörteile, die bestimmungsgemäß elektrische/leitfähige Verbindungen zu einem NIS oder NIS E entsprechend der bestimmungsgemäßen Verwendung des NIS/NIS E aufweisen.
Dieses Dokument legt keine Anforderungen an die Software in programmierbaren NIS Es fest.
ANMERKUNG   IEC 60601 1:2005+AMD1:2012+AMD2:2020, Abschnitt 14, behandelt die Prozesse des Software-Lebenszyklus.
Dieses Dokument legt keine Anforderungen hinsichtlich der Cybersicherheit fest.

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d’essai - Partie 4: Systèmes d'injection à aiguille contenant de l'électronique (ISO 11608-4:2022, Version corrigée 2024-12)

Le présent document spécifie les exigences et les méthodes d'essai pour les systèmes d'injection à aiguille (NIS) contenant de l'électronique avec ou sans logiciel (NIS-E).
Le système d'injection à aiguille contenant de l'électronique peut être à usage unique ou réutilisable et peut fonctionner avec ou sans connexions électriques/conductrices à d'autres dispositifs. Le système est destiné à administrer des médicaments à un patient par auto-administration ou par administration par un autre opérateur (par exemple, un soignant ou un prestataire de soins de santé).
Le présent document s'applique aux accessoires électroniques destinés à être connectés physiquement à un NIS ou NIS-E conformément à l'utilisation prévue du NIS/NIS-E.
Le présent document s'applique également aux accessoires électroniques destinés à avoir des connexions électriques/conductrices à un NIS ou NIS-E conformément à l'utilisation prévue du NIS/NIS-E.
Le présent document ne spécifie pas les exigences relatives au logiciel des NIS-E programmables.
NOTE            L'IEC 60601-1:2005+AMD1:2012+AMD2:2020, Article 14 couvre les processus du cycle de vie du logiciel.
Le présent document ne spécifie pas d'exigences relatives à la cybersécurité.

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del: Peresa za injiciranje z elektronskimi elementi (ISO 11608-4:2022)

Ta dokument določa zahteve in preskusne metode za peresa za injiciranje (NIS) z elektronskimi elementi (NIS-E) s programsko opremo ali brez nje. Peresa za injiciranje z elektronskimi elementi so lahko namenjena enkratni ali večkratni uporabi in delujejo s pomočjo električnih/prevodnih povezav z drugimi napravami ali brez njih. Tak sistem je namenjen dovajanju zdravil bolniku, pri čemer si bolnik zdravilo injicira sam, ali pa to stori nekdo drug (npr. negovalec ali zdravstveni delavec). Ta dokument se uporablja za elektronske pripomočke, ki se fizično povežejo s peresom za injiciranje ali peresom za injiciranje z elektronskimi elementi v skladu s predvideno uporabo peresa za injiciranje/peresa za injiciranje z elektronskimi elementi. Ta dokument se uporablja tudi za elektronske pripomočke, ki so predvideni za vzpostavljanje električne/prevodne povezave s peresom za injiciranje ali peresom za injiciranje z elektronskimi elementi v skladu s predvideno uporabo peresa za injiciranje/peresa za injiciranje z elektronskimi elementi. Ta dokument ne določa zahtev za programsko opremo programirljivih peres za injiciranje z elektronskimi elementi.
OPOMBA: Procesi življenjskega cikla programske opreme so obravnavani v točki 14 standarda IEC 60601-1:2005+AMD1:2012+AMD2:2020. Ta dokument ne določa zahtev za kibernetsko varnost.

General Information

• Status: Published
• Publication Date: 03-May-2022
• Withdrawal Date: 29-Nov-2022
• 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: 04-May-2022
• Completion Date: 04-May-2022
• Ref Project: SIST EN ISO 11608-4:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)

Relations

• Replaces: EN ISO 11608-4:2007 - Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
• Effective Date: 11-May-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 11608-4:2008
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del:
Peresa za injiciranje z elektronskimi elementi (ISO 11608-4:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part
4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile
enthalten (ISO 11608-4:2022)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d’essai -
Partie 4: Systèmes d'injection à aiguille contenant de l'électronique (ISO 11608-4:2022)
Ta slovenski standard je istoveten z: EN ISO 11608-4:2022
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 11608-4
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-4:2007
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 4: Needle-based
injection systems containing electronics (ISO 11608-
4:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 4: Systèmes Verwendung - Anforderungen und Prüfverfahren - Teil
d'injection à aiguille contenant de l'électronique (ISO 4: Kanülenbasierte Injektionssysteme, die
11608-4:2022) elektronische Bauteile enthalten (ISO 11608-4:2022)
This European Standard was approved by CEN on 2 January 2022.

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, Turkey 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-4:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11608-4:2022) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and catheters" in collaboration with 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 November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
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 11608-4:2007.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11608-4:2022 has been approved by CEN as EN ISO 11608-4:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-4
Second edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 4:
Needle-based injection systems
containing electronics
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 4: Systèmes d'injection à aiguille contenant de l'électronique
Reference number
ISO 11608-4:2022(E)
ISO 11608-4:2022(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 11608-4:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 Abbreviated terms .11
5 General requirements .11
5.1 Conditions for application of NIS-E . 11
5.2 General design requirements . 12
5.3 Risk approach and usability engineering .12
6 General requirements for testing .13
6.1 Type tests .13
6.2 Number of samples .13
6.3 Ambient temperature, humidity, atmospheric pressure . 18
7 Identification and marking of NIS-E .18
8 Protection against electrical hazards .18
8.1 General . 18
8.2 Humidity preconditioning treatment. 18
8.3 Requirements and test methods . 19
8.3.1 General . 19
8.3.2 Applied parts . 19
8.3.3 Requirements related to power sources . 21
8.3.4 Limitation of current for accessible parts and applied parts .22
8.4 Separation of parts (Type X and Type Y) . 22
8.4.1 Means of protection (MOP) . 22
8.4.2 Separation of patient connection . 23
8.4.3 Maximum mains voltage . 24
8.4.4 Working voltage . 24
8.5 Patient leakage current and touch current (Type X and Type Y NIS-E) . 25
8.5.1 General . 25
8.5.2 Measurement of patient leakage current .29
8.5.3 Measurement of touch current . 32
8.6 Insulation (Type X and Type Y) . 33
8.6.1 General . 33
8.6.2 Distance through solid insulation or use of thin sheet material .33
8.6.3 Dielectric strength .34
8.7 Insulation other than wire insulation .34
8.7.1 Mechanical strength and resistance to heat.34
8.8 Creepage distances and air clearances (Type X and Type Y NIS-E) . 35
8.8.1 General . 35
8.9 Specific hazardous situations .36
8.9.1 General .36
8.9.2 Emissions, deformation of enclosure or exceeding maximum temperature .36
8.9.3 Exceeding leakage current or voltage limits .38
8.9.4 Specific mechanical hazards .38
8.10 Single fault conditions (Type X and Type Y) .
...