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 11608-4:2020)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO/DIS 11608-4:2020)

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.
Die kanülenbasierten Injektionssysteme, die elektronische Bauteile enthalten, können zum einmaligen Gebrauch bestimmt, wiederverwendbar und/oder wiederaufladbar sein. Sie sind 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 gilt für elektronische Zubehörteile, die zur physischen Verbindung mit einem NIS oder NIS E während der bestimmungsgemäßen Verwendung des NIS/NIS E vorgesehen sind.
ANMERKUNG   Dieses Dokument enthält relevante Anforderungen, die der Normenreihe IEC 60601 entstammen.

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)

Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del: Peresa za injiciranje z elektronskimi elementi (ISO/DIS 11608-4:2020)

General Information

• Status: Not Published
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 11-Jun-2021
• Completion Date: 11-Jun-2021
• Ref Project: oSIST prEN ISO 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)

RELATIONS

• Revised: 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: 05-Dec-2018

Standards Content (sample)

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.

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oSIST prEN ISO 11608-4:2020
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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
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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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ISO copyright office
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ii © ISO 2020 – All rights reserved
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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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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
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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.
© ISO 2020 – All rights reserved v
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oSIST prEN ISO 11608-4:2020
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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.
vi © ISO 2020 – All rights reserved
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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.

© ISO 2020 – All rights reserved 1
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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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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
...