prEN ISO 11608-4

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)

2016-10-11 GVN: WI deleted following cancellation of equivalent ISO project

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO/DIS 11608-4:2016)

Dieser Teil von ISO 11608 legt Bezugsanforderungen und Prüfverfahren für kanülenbasierte Injektionssysteme (en: needle-based injection systems, NIS), die elektronische Bauteile (mit oder ohne Software) enthalten, fest, die zur Verwendung mit Kanülen und austauschbaren oder nicht austauschbaren Behältern vorgesehen sind. Die elektronischen kanülenbasierten Injektionssysteme (en: electronic needle based injection systems, ENIS) können zum einmaligen Gebrauch bestimmt, wiederverwendbar und/oder wiederaufladbar sein. Sie sind dafür vorgesehen, die Arzneigabe durch Eigenanwendung oder mit Unterstützung an einen Endverbraucher abzugeben.
Dieser Teil von ISO 11608 ist nicht anwendbar für Geräte, die Arzneimittel abgeben können, während sie an eine externe Stromversorgung angeschlossen sind.
Dieser Teil von ISO 11608 ist nicht anwendbar für elektrische Zusatzgeräte wie z. B. Ladegeräte für das Gerät.
Dieser Teil von ISO 11608 ist nicht anwendbar für kanülenlose Injektoren (wie in ISO 21649 behandelt).

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 4: Systèmes d'injection à aiguille électroniques (ISO/DIS 11608-4:2016)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del: Peresa za injiciranje z elektronskimi elementi (ISO/DIS 11608-4:2016)

General Information

• Status: Not Published
• Publication Date: 13-Sep-2017
• Withdrawal Date: 13-Mar-2018
• 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: 4098 - Decision to abandon - Enquiry
• Completion Date: 07-Oct-2016
• Ref Project: oSIST prEN ISO 11608-4:2016 - Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)

Relations

• Revises: 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: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2016
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del:
Peresa za injiciranje z elektronskimi elementi (ISO/DIS 11608-4:2016)
Needle-based injection systems for medical use - Requirements and test methods - Part
4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile
enthalten (ISO/DIS 11608-4:2016)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 4: Systèmes d'injection à aiguille électroniques (ISO/DIS 11608-4:2016)
Ta slovenski standard je istoveten z: prEN ISO 11608-4
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 11608-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2016-02-11 2016-05-10
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 électroniques
ICS: 11.040.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11608-4:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

ISO/DIS 11608-4:2015(E)
ISO/DIS 11608-4:2016
Contents
Foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Symbols and abbreviated terms . 24
5 General requirements . 24
6 General requirements for testing . 24
7 Classification of ENIS . 25
8 Identification, marking and documentation . 25
9 Protection against electrical hazards . 34
10 Protection against mechanical hazards . 80
11 Protection against unwanted and excessive radiation hazards . 80
12 Protections against excessive temperatures and other hazards . 81
13 Accuracy of controls and instruments and protection against hazardous outputs . 82
14 Hazardous situations and fault conditions . 83
15 Programmable medical electrical systems . 87
16 Construction of ME equipment . 87
17 ME systems . 91
18 Requirements for Electromagnetic Compatibility (EMC) . 92
19 Test report . 94
© ISO 2015, Published in Switzerland
Annex A (informative) Rationale for statistical sampling . 95
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2015 – All rights reserved © ISO #### – All rights reserved 3

ISO/DIS 11608-4:2016
Contents
Foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Symbols and abbreviated terms . 24
5 General requirements . 24
6 General requirements for testing . 24
7 Classification of ENIS . 25
8 Identification, marking and documentation . 25
9 Protection against electrical hazards . 34
10 Protection against mechanical hazards . 80
11 Protection against unwanted and excessive radiation hazards . 80
12 Protections against excessive temperatures and other hazards . 81
13 Accuracy of controls and instruments and protection against hazardous outputs . 82
14 Hazardous situations and fault conditions . 83
15 Programmable medical electrical systems . 87
16 Construction of ME equipment . 87
17 ME systems . 91
18 Requirements for Electromagnetic Compatibility (EMC) . 92
19 Test report . 94
Annex A (informative) Rationale for statistical sampling . 95

© ISO #### – All rights reserved 3

ISO/DIS 11608-4:2016
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 all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 84 Devices for administration of medicinal
products and intravascular catheters.
ISO 11608 consists of the following parts, under the general title Needle-based injection systems for
medical use — Requirements and test methods:
 Part 1: Needle-based injection systems
 Part 2: Needles
 Part 3: Finished containers
 Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
 Part 5: Automated functions
 Part 6: On-body delivery system
 Part 7: Requirements for accessibility for persons with visual impairment

4 © ISO #### – All rights reserved

ISO/DIS 11608-4:2016
Introduction
This part of ISO 11608 covers Needle-based injection systems containing electronics (with or without
software). These injectors are primarily intended to administer medicinal products to humans. This
part of ISO 11608 provides performance requirements regarding essential aspects of the design so that
variations of such injectors are not unnecessarily restricted.
For historical reasons (ISO 11608-1 was published before ISO 11608-4), the first edition of this part of
ISO 11608 was limited to pen-injectors with electromechanical drive systems. Pen-injectors only
equipped with electronics were covered in ISO 11608-1. Given the set of additional tests that need to be
performed regarding needle-based injection systems containing electronics (ENIS) regardless of what
the electronics are used for, it was decided to have all types of electronics covered by this standard.
Materials to be used for construction are not specified, as their selection will depend on the design, the
intended use and the process of manufacture used by individual manufacturers.
There are other international and national standards and guidance publications and, in some countries,
national regulations that are applicable to medical devices and pharmaceuticals. This part of the
standard serves as a stand-alone document for ENIS that specifies relevant aspects of the IEC 60601
series fo
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