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

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)

Dieses Dokument legt die Anforderungen und Prüfverfahren für kanülenbasierte Injektionssysteme (en: needle-based injection systems, NISs) 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)

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)

General Information

Status
Published
Public Enquiry End Date
19-Apr-2020
Publication Date
15-Jun-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
20-May-2022
Due Date
25-Jul-2022
Completion Date
16-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 11608-4:2022
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
SIST EN ISO 11608-4:2022 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11608-4:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 11608-4:2022
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 11608-4:2022
EN ISO 11608-4:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 11608-4:2022
EN ISO 11608-4:2022 (E)
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.
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SIST EN ISO 11608-4:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 11608-4:2022
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 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 11608-4:2022
ISO 11608-4:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11608-4:2022
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) .............................................................................................................38

8.10.1 General .....................................................................................................................................................................................38

8.10.2 Failure of thermostats and temperature limiting devices .........................................................38

8.10.3 Leakage of liquid from batteries .......................................................................................................................39

8.10.4 Locking of moving parts ........................................................................................................................................... 39

8.10.5 Additional test criteria for motor-operated NIS-E ............................................................................39

iii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 11608-4:2022
ISO 11608-4:2022(E)

8.10.6 NIS-E intended for used in conjunction with oxygen rich environments .....................39

8.10.7 Power supply (Type Y) ...............................................................................................................................................39

8.11 Pre-conditioning for the influence of fluid leakage ............................................................................................40

9 Electromagnetic compatibility (EMC) ........................................................................................................................................41

9.1 General requirements ................................................................................................................................................................... 41

9.1.1 Risk approach process for NIS-E ....................................................................................................................... 41

9.1.2 Non-medical electrical equipment used with NIS-E ........................................................................ 41

9.1.3 General test conditions .............................................................................................................................................. 42

9.2 NIS-E identification, marking and documents ........................................................................................................ 47

9.2.1 Instruction for use in relation to EMC .......................................................................................................... 47

9.2.2 Documentation of the tests .................................................................................................................................... 47

9.3 Electromagnetic emissions requirements for NIS-E .........................................................................................48

9.3.1 Protection of radio services and other equipment ...........................................................................48

9.3.2 Protection of the public mains network .....................................................................................................48

9.3.3 Emissions requirements summary (Type X and Type Y) ...........................................................49

9.4 Electromagnetic immunity requirements for NIS-E ..........................................................................................49

9.4.1 General .....................................................................................................................................................................................49

9.4.2 Operating modes ............................................................................................................................................................. 51

9.4.3 Non-medical electrical equipment .................................................................................................................. 51

9.4.4 Immunity test levels ..................................................................................................................................................... 51

9.4.5 Immunity to proximity fields from RF wireless communications equipment .........56

9.4.6 Immunity to proximity magnetic fields in the frequency range 9 kHz to

13,56 MHz ..............................................................................................................................................................................58

10 Protection against mechanical hazards ..................................................................................................................................58

10.1 General ........................................................................................................................................................................................................58

10.2 Shock ............................................................................................................................................................................................................58

10.3 Vibration ...................................................................................................................................................................................................58

10.3.1 Sinusoidal vibration ......................................................................................................................................................58

10.3.2 Random vibration ...........................................................................................................................................................58

10.4 Impact of OBDS enclosures ....................................................................................................................................................... 59

10.5 Push ............................................................................................................................................................................................................... 59

11 Programmable NIS-E ....................................................................................................................................................................................59

Annex A (informative) Identification of immunity pass/fail criteria ............................................................................60

Annex B (informative) Rationale for using 240 V for testing some requirements ..........................................62

Bibliography .............................................................................................................................................................................................................................63

© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 11608-4:2022
ISO 11608-4:2022(E)
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 (see 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 (see 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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal

products and catheters, in collaboration with the European Committee for Standardization (CEN)

Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on

technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 11608-4:2006), which has been

technically revised.
The main changes are as follows:

— this document has been revised in its entirety to include requirements from the IEC 60601 series

that pertain to hand-held medical injectors.
A list of all parts in the ISO 11608 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 11608-4:2022
ISO 11608-4:2022(E)
Introduction

Needle-based injection systems, including on-body delivery systems (OBDSs), containing electronics

with or without software, are primarily intended to administer medicinal products to humans.

Performance requirements regarding essential electrotechnical aspects have been selected with the

intention not to restrict the Electronic Needle-based Injection System (NIS-E) design unnecessarily

when applying the document.

The first edition of this document was limited to pen-injectors with electromechanical drive. Pen-

injectors only equipped with electronics were covered in ISO 11608-1.

Materials used for construction are not specified in this document, 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 document is

applicable to NIS-E and specifies relevant aspects of IEC 60601-1:2005+AMD1:2012+AMD2:2020,

IEC 60601-1-2:2014+AMD1:2020 and IEC 60601-1-11:2015+AMD1:2020 for this particular device type.

This document does not specify non-electrotechnical requirements and test methods for NISs when

specified by ISO 11608-1.

Developers and manufacturers of NIS-Es are encouraged to investigate and determine whether there

are any other requirements relevant to the safety or marketability of their NIS-Es. For example, this

document should be used in conjunction with IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11. A risk-

based approach is expected to be applied during the design, development, and manufacture of the

product. Given the specific medicinal product intended use and environment, this might result in

product-specific requirements and test methods that differ from what is outlined in this document.

This document is intended to be used for type testing (testing of the development result) of NIS-E. It is

not intended to be used for batch release testing.

This document introduces the notion of Type X NIS-E and Type Y NIS-E. Type X NIS-E is a device type

without any physical cabled connection to other devices. Type Y NIS-E has such connections. The

electrical requirements in this document for Type X NIS-E is a subset of the requirements for Type Y

NIS-E.
© ISO 2022 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 11608-4:2022
INTERNATIONAL STANDARD ISO 11608-4:2022(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 4:
Needle-based injection systems containing electronics
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

CISPR 11, Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics –

Limits and methods of measurement

CISPR 32, Electromagnetic compatibility of multimedia equipment — Emission requirements

ISO 11608-1:2022, Needle-based injection systems for medical use — Requirements and test methods —

Part 1: Needle-based injection systems

ISO 7137, Aircraft — Environmental conditions and test procedures for airborne equipment

ISO 14971:2019, Medical devices — Application of risk management to medical devices

IEC 60086-4, Primary batteries — Part 4: Safety of lithium batteries

IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and

guidance
IEC 60529, Degrees of protection provided by enclosures (IP Code)

IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements

for basic safety and essential performance
© ISO 2022 – All rights reserved
---------------------- Page: 13 ----------------------
SIST EN ISO 11608-4:2022
ISO 11608-4:2022(E)
...

SLOVENSKI STANDARD
oSIST prEN ISO 11608-4:2020
01-april-2020

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del:

Peresa za injiciranje z elektronskimi elementi (ISO/DIS 11608-4:2020)

Needle-based injection systems for medical use - Requirements and test methods - Part

4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2020)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und

Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile

enthalten (ISO/DIS 11608-4:2020)

Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d’essai -

Partie 4: Systèmes d’injection à aiguille électroniques (ISO/DIS 11608-4:2020)
Ta slovenski standard je istoveten z: prEN ISO 11608-4
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 11608-4:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 11608-4:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 11608-4:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-4
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 4:
Needle-based injection systems containing electronics
Stylos-injecteurs à usage médical —

Partie 4: Exigences et méthodes d'essai pour stylos-injecteurs électroniques et électromécaniques

ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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 11608-4:2020(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 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 11608-4:2020
ISO/DIS 11608-4:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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

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Published in Switzerland
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oSIST prEN ISO 11608-4:2020
ISO/DIS 11608-4:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Symbols and abbreviated terms ........................................................................................................................................................... 9

5 General requirements ..................................................................................................................................................................................... 9

5.1 Conditions for application of NIS-E ....................................................................................................................................... 9

5.2 General design requirements ..................................................................................................................................................10

5.3 Risk approach and usability engineering ......................................................................................................................10

6 General requirements for testing ....................................................................................................................................................10

6.1 Type tests ..................................................................................................................................................................................................10

6.2 Number of samples ..........................................................................................................................................................................11

6.3 Ambient temperature, humidity, atmospheric pressure .................................................................................11

7 Identification and marking of NIS-E ..............................................................................................................................................11

8 Protection against electrical hazards ..........................................................................................................................................11

8.1 General ........................................................................................................................................................................................................11

8.2 Humidity preconditioning treatment ...............................................................................................................................11

8.3 Requirements and test methods ...........................................................................................................................................12

8.3.1 General...................................................................................................................................................................................12

8.3.2 Applied parts ....................................................................................................................................................................13

8.3.3 Requirements related to power sources (Type Y) ...........................................................................14

8.3.4 Limitation of current or energy for accessible parts and applied parts .......................15

8.4 Separation of parts ...........................................................................................................................................................................16

8.4.1 Means of protection (MOP)..................................................................................................................................16

8.4.2 Separation of patient connection ...................................................................................................................16

8.4.3 Maximum mains voltage ........................................................................................................................................17

8.4.4 Working voltage .............................................................................................................................................................17

8.5 Patient leakage current and touch current ..................................................................................................................17

8.5.1 General...................................................................................................................................................................................17

8.5.2 Measurement of patient leakage current.................................................................................................20

8.5.3 Measurement of touch current .........................................................................................................................22

8.6 Insulation ..................................................................................................................................................................................................23

8.6.1 General...................................................................................................................................................................................23

8.6.2 Distance through solid insulation or use of thin sheet material .................. ........................23

8.6.3 Dielectric strength .......................................................................................................................................................24

8.7 Insulation other than wire insulation ..............................................................................................................................24

8.7.1 Mechanical strength and resistance to heat ..........................................................................................24

8.8 Creepage distances and air clearances ............................................................................................................................25

8.8.1 General...................................................................................................................................................................................25

8.9 Specific hazardous situations ..................................................................................................................................................26

8.9.1 General...................................................................................................................................................................................26

8.9.2 Emissions, deformation of enclosure or exceeding maximum temperature ............26

8.9.3 Exceeding leakage current or voltage limits .........................................................................................28

8.9.4 Specific mechanical hazards ...............................................................................................................................28

8.10 Single fault conditions ...................................................................................................................................................................28

8.10.1 General...................................................................................................................................................................................28

8.10.2 Failure of thermostats and temperature limiting devices.........................................................28

8.10.3 Leakage of liquid from batteries .....................................................................................................................29

8.10.4 Locking of moving parts .........................................................................................................................................29

8.10.5 Additional test criteria for motor-operated NIS-E ...........................................................................29

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oSIST prEN ISO 11608-4:2020
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8.10.6 Failures of components in NIS-E used in conjunction with oxygen rich

environments ...................................................................................................................................................................29

8.10.7 Power supply ...................................................................... ..............................................................................................29

8.11 Pre-conditioning for the influence of fluid leakage ..............................................................................................30

9 Electromagnetic compatibility (EMC) .........................................................................................................................................30

9.1 General requirements ....................................................................................................................................................................30

9.1.1 Risk assessment process for NIS-E ...............................................................................................................30

9.1.2 Non-ME Equipment used with NIS-E ..........................................................................................................30

9.1.3 General test conditions ............................................................................................................................................31

9.2 NIS-E identification, marking and documents ..........................................................................................................34

9.2.1 Instruction for use for EMC .................................................................................................................................34

9.2.2 Documentation of the tests ..................................................................................................................................35

9.3 Electromagnetic emissions requirements for NIS-E ...........................................................................................36

9.3.1 Protection of radio services and other equipment ..........................................................................36

9.3.2 Protection of the public mains network ...................................................................................................36

9.3.3 Emissions requirements summary ...............................................................................................................37

9.4 Electromagnetic immunity requirements for NIS-E ............................................................................................37

9.4.1 General...................................................................................................................................................................................37

9.4.2 Operating modes ...........................................................................................................................................................39

9.4.3 Non-ME equipment ....................................................................................................................................................39

9.4.4 Immunity test levels...................................................................................................................................................39

9.4.5 Immunity to proximity fields from RF wireless communications equipment ........43

10 Protection against mechanical hazards.....................................................................................................................................45

10.1 General ........................................................................................................................................................................................................45

10.2 Free Fall ......................................................................................................................................................................................................45

10.3 Shock.............................................................................................................................................................................................................45

10.4 Vibration ....................................................................................................................................................................................................45

10.4.1 Sinusoidal vibration ...................................................................................................................................................45

10.4.2 Random vibration ........................................................................................................................................................45

10.5 Moulding stress relief .....................................................................................................................................................................45

10.6 Impact (only for OBDS) .................................................................................................................................................................46

10.7 Push ...............................................................................................................................................................................................................46

11 Programmable NIS-E .....................................................................................................................................................................................46

Annex A (informative) Identification of immunity pass/fail criteria ..............................................................................47

Annex B (informative) Rationale for using 250V for testing some requirements .............................................49

Bibliography .............................................................................................................................................................................................................................50

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oSIST prEN ISO 11608-4:2020
ISO/DIS 11608-4:2020(E)
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 (see 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 (see 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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal

products and catheters.

This second edition cancels and replaces the first edition (ISO 11608-4:2006), which has been

technically revised.
A list of all parts in the ISO 11608 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
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oSIST prEN ISO 11608-4:2020
ISO/DIS 11608-4:2020(E)
Introduction

Needle-based injection systems including on-body delivery systems (OBDSs) containing electronics

with or without software are primarily intended to administer medicinal products to humans. This

document 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 document

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 on

needle-based injection systems containing electronics (NIS-E) regardless of what the electronics are

used for, it was decided to have all types of NIS-Es covered by this document.

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 document serves

as a stand-alone document for NIS-E that specifies relevant aspects of the IEC 60601 series for this

particular device type. This document does not specify non-electrotechnical test methods, conditions,

or acceptance criteria for NISs when specified by other parts of ISO 11608.

Developers and manufacturers of NIS-Es are encouraged to investigate and determine whether there

are any other requirements relevant to the safety or marketability of their products. Their requirements

might supersede or complement those contained in this document.

Manufacturers are expected to follow a risk-based approach during the design, development and

manufacture of the product. Given the specific medicinal product intended use and environment, this

might result in product-specific requirements and test methods that differ from what is outlined in this

document.

Guidance on transition periods for implementing the requirements of this document is given in

ISO/TR 19244.
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oSIST prEN ISO 11608-4:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 11608-4:2020(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 4:
Needle-based injection systems containing electronics
1 Scope

This document specifies requirements and test methods for needle-based injection systems (NISs)

containing electronics with or without software.

The needle-based injection system containing electronics can be single use, reusable, and/or

rechargeable. It 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 which are intended to be physically connected to a NIS

or NIS-E during the NIS/NIS-E intended use.
NOTE This document includes relevant requirements derived from IEC 60601 series.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 11608-1, Needle-based injection systems for medical use -- Requirements and test methods -- Part 1:

Needle-based injection systems

ISO 14971:2019, Medical devices — Application of risk management to medical devices

IEC 60086-4, Primary batteries - Part 4: Safety of lithium batteries
IEC 60529, Degrees of protection provided by enclosures (IP Code)

I EC 6 06 01-1:20 05+A M D1: 2012 , Medical electrical equipment -- Part 1: General requirements for basic

safety and essential performance

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and

essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-11:2015, Medical electrical equipment — Part 1-11: General requirements for basic safety and

essential performance — Collateral standard: Requirements for medical electrical equipment and medical

electrical systems used in the home healthcare environment

IEC 60950-1, Information technology equipment – Safety – Part 1: General requirements

IEC 62133-1, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety

requirements for portable sealed secondary cells, and for batteries made from them, for use in portable

applications - Part 1: Nickel systems

1) To be published (revises ISO 11608-1:2012). Stage at time of publication: ISO/DIS 11608-1:2020.

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oSIST prEN ISO 11608-4:2020
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IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety

requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in

portable applications - Part 2: Lithium systems
ISO 62304, Medical Device Software — Software Life-cycle Processes

IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices

IEC 62368-1, Audio/video, information and communication technology equipment - Part 1: Safety

requirements

IEC 60721-3-7, Classification of environmental conditions - Part 3-7: Classification of groups of

environmental parameters and their severities - Portable and non-stationary use

ISO/IEC/IEEE 12207, Systems and software engineering — Software life cycle processes

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 11608-1 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
access cover

part of an enclosure or guard providing the possibility of access to electrical equipment parts for the

purpose of adjustment, inspection, replacement or repair
3.2
accessible part

part of electrical equipment other than an applied part that can be touched by means of the standard

test finger
Note 1 to entry: See also 8.3.2.
3.3
air clearance
shortest distance in air between two conductive parts
[SOURCE: IEC 60664-1:2007, 3.2. Modified: "path" changed to "distance"]
3.4
applied part

part of NIS-E that in normal use (3.30) necessarily comes into physical contact with the patient (3.35)

for NIS-E to perform its function

Note 1 to entry: See also 8.3 regarding the treatment of parts that do not fall within the definition of applied

parts but need to be treated as applied parts as a result of applying the risk assessment process.

Note 2 to entry: See also 3.37 for the definition of the associated term patient connection (3.37).

3.5
basic insulation
insulation providing basic protection against electric shock

Note 1 to entry: This definition does not include insulation used exclusively for functional purposes.

[SOURCE: IEC 60601-1:2012, ed 3.1, 3.9]
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oSIST prEN ISO 11608-4:2020
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3.6
basic safety

freedom from unacceptable risk directly caused by physical hazards when NIS-E is used under normal

condition and single fault condition (3.46)
3.7
class I

electrical equipment in which protection against electric shock does not rely on basic insulation (3.5)

only, but which includes an additional safety precaution in that means are provided for accessible parts

(3.2) of metal or internal parts of metal to be protectively earthed
3.8
class II

electrical equipment in which protection against electric shock does not rely on basic insulation only,

but in which additional safety precautions such as double insulation or reinforced insulation (3.42) are

provided, there being no provision for protective earthing or reliance upon installation conditions

3.9
creepage distance

shortest distance along the surface of a solid insulating material between two conductive parts

3.10
direct cardiac application

use of applied part (3.4) that can come in direct contact with the patient’s heart

3.11
double insulat
...

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