SIST EN ISO 11608-4:2022

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

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

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

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

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

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

General Information

• Status: Published
• Public Enquiry End Date: 19-Apr-2020
• Publication Date: 15-Jun-2022
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 20-May-2022
• Due Date: 25-Jul-2022
• Completion Date: 16-Jun-2022
• Ref Project: EN ISO 11608-4:2022 - Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022, Corrected version 2024-12)

Relations

• Replaces: SIST EN ISO 11608-4:2008 - Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
• Effective Date: 01-Jul-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 11608-4:2008
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del:
Peresa za injiciranje z elektronskimi elementi (ISO 11608-4:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part
4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile
enthalten (ISO 11608-4:2022)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d’essai -
Partie 4: Systèmes d'injection à aiguille contenant de l'électronique (ISO 11608-4:2022)
Ta slovenski standard je istoveten z: EN ISO 11608-4:2022
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11608-4
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-4:2007
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 4: Needle-based
injection systems containing electronics (ISO 11608-
4:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 4: Systèmes Verwendung - Anforderungen und Prüfverfahren - Teil
d'injection à aiguille contenant de l'électronique (ISO 4: Kanülenbasierte Injektionssysteme, die
11608-4:2022) elektronische Bauteile enthalten (ISO 11608-4:2022)
This European Standard was approved by CEN on 2 January 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-4:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11608-4:2022) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and catheters" in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11608-4:2007.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11608-4:2022 has been approved by CEN as EN ISO 11608-4:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-4
Second edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 4:
Needle-based injection systems
containing electronics
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 4: Systèmes d'injection à aiguille contenant de l'électronique
Reference number
ISO 11608-4:2022(E)
ISO 11608-4:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11608-4:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 Abbreviated terms .11
5 General requirements .11
5.1 Conditions for application of NIS-E . 11
5.2 General design requirements . 12
5.3 Risk approach and usability engineering .12
6 General requirements for testing .13
6.1 Type tests .13
6.2 Number of samples .13
6.3 Ambient temperature, humidity, atmospheric pressure . 18
7 Identification and marking of NIS-E .18
8 Protection against electrical hazards .18
8.1 General . 18
8.2 Humidity preconditioning treatment. 18
8.3 Requirements and test methods . 19
8.3.1 General . 19
8.3.2 Applied parts . 19
8.3.3 Requirements related to power sources . 21
8.3.4 Limitation of current for accessible parts and applied parts .22
8.4 Separation of parts (Type X and Type Y) . 22
8.4.1 Means of protection (MOP) . 22
8.4.2 Separation of patient connection . 23
8.4.3 Maximum mains voltage . 24
8.4.4 Working voltage . 24
8.5 Patient leakage current and touch current (Type X and Type Y NIS-E) . 25
8.5.1 General . 25
8.5.2 Measurement of patient leakage current .29
8.5.3 Measurement of touch current . 32
8.6 Insulation (Type X and Type Y) . 33
8.6.1 General . 33
8.6.2 Distance through solid insulation or use of thin sheet material .33
8.6.3 Dielectric strength .34
8.7 Insulation other than wire insulation .34
8.7.1 Mechanical strength and resistance to heat.34
8.8 Creepage distances and air clearances (Type X and Type Y NIS-E) . 35
8.8.1 General . 35
8.9 Specific hazardous situations .36
8.9.1 General .36
8.9.2 Emissions, deformation of enclosure or exceeding maximum temperature .36
8.9.3 Exceeding leakage current or voltage limits .38
8.9.4 Specific mechanical hazards .38
8.10 Single fault conditions (Type X and Type Y) .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 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
iv
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.
v
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.
vi
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 11608-4:2022(E)
IEC 60601-1-2:2014+AMD1: 2020, 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+AMD1: 2020, 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 60721-3-7:1995+AMD1: 1996, Classification of environmental conditions — Part 3-7: Classification of
groups of environmental parameters and their severities — Portable and non-stationary use
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
IEC 62304, Medical device software — Software life cycle processes
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 60695-11-10:2013, Fire hazard testing — Part 11-10: Test flames — 50 W horizontal and vertical flame
test methods
IEC 60950-1:2005+AMD1: 2009+ AMD2: 2013, Information technology equipment — Safety — Part 1:
General requirements
IEC 60747-5-5, Semiconductor devices — Part 5-5: Optoelectronic devices — Photocouplers
IEC 61000-3-2, Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current
emissions (equipment input current ≤16 A per phase)
IEC 61000-3-3, Electromagnetic compatibility (EMC) - Part 3-3: Limits — Limitation of voltage changes,
voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16
A per phase and not subject to conditional connection
IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4, Electromagnetic compatibility (EMC) — Part 4-4: Testing and measurement techniques -
Electrical fast transient/burst immunity test
IEC 61000-4-5, Electromagnetic compatibility (EMC) — Part 4-5: Testing and measurement techniques —
Surge immunity test
IEC 61000-4-6, Electromagnetic compatibility (EMC) — Part 4-6: Testing and measurement techniques —
Immunity to conducted disturbances, induced by radio-frequency fields
IEC 61000-4-8, Electromagnetic compatibility (EMC) — Part 4-8: Testing and measurement techniques —
Power frequency magnetic field immunity test
IEC 61000-4-11, Electromagnetic compatibility (EMC) — Part 4-11: Testing and measurement techniques
— Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current
up to 16 A per phase
IEC 61000-4-39, Electromagnetic compatibility (EMC) — Part 4-39: Testing and measurement techniques
— Radiated fields in close proximity—– Immunity test
IEC 60085, Electrical insulation — Thermal evaluation and designation
ISO 11608-4:2022(E)
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 terminology 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
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.1]
3.2
accessible part
part of electrical equipment other than an applied part that can be touched by means of the small test
finger
Note 1 to entry: See also 8.3.2.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.2, modified — "test finger" changed to "small
test finger", Note 1 to entry added.]
3.3
air clearance
shortest distance in air between two conductive parts
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.5, modified — "shortest path" changed to
"shortest distance".]
3.4
applied part
part of electronic needle-based injection system (3.13) that, in normal use (3.28) ,necessarily comes
into physical contact with the patient (3.32) for electronic needle-based injection system to perform its
function
Note 1 to entry: See also 8.3.2.1 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 approach process.
Note 2 to entry: See also definition of the associated term patient connection (3.33).
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.8, modified — "ME equipment and ME system"
changed to "electronic needle-based injection system", Note 1 to entry deleted, Note 2 changed to Note 1
to entry and amended, Note 3 changed to note 2 to entry and amended.]
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 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.9, modified — Note 1 to entry changed.]
ISO 11608-4:2022(E)
3.6
basic safety
freedom from unacceptable risk directly caused by physical hazards when electronic needle-based
injection system (3.13) is used under normal condition and single fault condition (3.42)
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.10, modified — "ME equipment" changed to
"electronic needle-based injection system".]
3.7
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 (3.38) are
provided, there being no provision for protective earthing or reliance upon installation conditions
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.14]
3.8
creepage distance
shortest distance along the surface of a solid insulating material between two conductive parts
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.19]
3.9
direct cardiac application
use of applied part (3.4) that can come in direct contact with the patient’s heart
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.22]
3.10
double insulation
insulation comprising both basic insulation (3.5) and supplementary insulation (3.44)
Note 1 to entry: Double insulation provides two means of protection (3.24).
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.23]
3.11
duty cycle
maximum activation (on) time followed by minimum deactivation (off) time
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.24, modified — “necessary for the safe
operation of the ME equipment" deleted.]
3.12
enclosure
exterior surface of electrical equipment or parts thereof
Note 1 to entry: For the purpose of testing to this document, metal foil, with specified dimensions, applied in
contact with parts of the exterior surface made of material with low conductivity or made of insulating material
is considered a part of the enclosure.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.26, modified — References to figures in Note 1
to entry deleted.]
3.13
NIS-E
electronic needle-based injection system
injection system containing electronics (with or without software) intended for parenteral
administration by injection of medicinal products using a needle or soft cannula and pre-filled or
operator-filled, replaceable or non-replaceable containers
ISO 11608-4:2022(E)
3.14
essential performance
performance of a clinical function, other than that related to basic safety (3.6), where loss or degradation
beyond the limits specified by the manufacturer results in an unacceptable risk
Note 1 to entry: Essential performance is most easily understood by considering whether its absence or
degradation would result in an unacceptable risk.
Note 2 to entry: ISO 11608-1 instead uses the term "primary function", which at a minimum, includes the dose
delivery function, achieved through assessment of dose accuracy.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.27, modified — Note 2 to entry added.]
3.15
F-type applied part
applied part (3.4) in which the patient (3.32) connections are isolated from other parts of the electronic
needle-based injection system (3.13) to such a degree that no current higher than the allowable patient
leakage current (3.34) flows if an unintended voltage originating from an external source is connected
to the patient (3.32), and thereby applied between the patient connection (3.33) and earth
Note 1 to entry: Also referred to as: F-type isolated (floating) applied part
Note 2 to entry: F-type applied parts are either type BF (Body Floating) applied parts or type CF (Cardiac
Floating) applied parts.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.29, modified — "ME equipment" changed to
"electronic needle-based injection system".]
3.16
functional connection
connection, electrical or otherwise, including those intended to transfer signals, data, power, or
substances
Note 1 to entry: Connection to a fixed supply mains (3.45) socket-outlet, whether single or multiple, is not
considered to result in a functional connection.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.33]
3.17
insulation co-ordination
mutual correlation of insulation characteristics of electrical equipment taking into account the expected
micro-environment and other influencing stresses
Note 1 to entry: This includes insulation types, creepage distances (3.8), air clearances (3.3), distance through
insulation, coatings, encapsulation, environmental aspects, etc.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.43]
3.18
intended use
intended purpose
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted
with, user profile, use environment, and operating principle are typical elements of the intended use (3.18).
Note 2 to entry: Intended use should not be confused with normal use. While both include the concept of use as
intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not
only the medical purpose, but maintenance, transport, etc. as well (IEC 60601 1:2005+AMD1: 2012+ AMD2: 2020,
3.44).
[SOURCE: ISO 14971:2019, 3.6, modified — Note 2 to entry added]
ISO 11608-4:2022(E)
3.19
leakage current
current that is not functional
Note 1 to entry: The following leakage currents are defined: touch current (3.48) and patient leakage current
(3.34).
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.47, modified — "Earth leakage current"
deleted from Note 1 to entry.]
3.20
mains part
part of electrical equipment forming a circuit that is intended to be connected to the supply mains (3.45)
Note 1 to entry: The mains part includes all conductive parts that are not separated from the supply mains (3.45)
by at least one means of protection (3.24).
Note 2 to entry: The protective earth conductor is not regarded as a part of the mains part.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.49, modified — Note 2 to entry changed.]
3.21
maximum mains voltage
voltage used for test purposes related to the voltage of the supply mains (3.45) and connected to certain
medical electrical equipment (3.25) parts
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.56, modified — Note to entry deleted.]
3.22
means of operator protection
MOOP
means of protection (3.24) for reducing the risk due to electric shock to persons other than the patient
(3.32)
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.58]
3.23
means of patient protection
MOPP
means of protection (3.24) for reducing the risk due to electric shock to the patient (3.32)
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.59]
3.24
means of protection
MOP
means for reducing the risk due to electric shock in accordance with specific requirements
Note 1 to entry: The specific requirements shall be in accordance with IEC 60601-1:2005+AMD1: 2012+ AMD2:
2020.
Note 2 to entry: Means of protection include insulation, air clearances (3.3), creepage distances (3.8), impedances,
and protective earth connections.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.60, modified — Note 1 to entry changed to
Note 2 to entry, new Note 1 to entry added.]
ISO 11608-4:2022(E)
3.25
medical electrical equipment
electrical equipment having an applied part (3.4) or transferring energy to or from the patient (3.32) or
detecting such energy transfer to or from the patient (3.32)
Note 1 to entry: Medical electrical equipment includes those accessories as defined by the manufacturer that are
necessary to enable the normal use (3.28) of the medical electrical equipment.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.63, modified — Notes 2 to 5 to entry deleted.]
3.26
medical electrical system
combination, as specified by its manufacturer, of items or equipment, at least one of which is medical
electrical equipment (3.25) intended to be inter-connected by functional connection (3.16) or by use of a
multiple socket-outlet
Note 1 to entry: Equipment, when mentioned in this document, should be taken to include medical electrical
equipment (3.25).
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.64, modified — "intended" added to the
definition.]
3.27
normal condition
condition in which all means provided for protection against hazards are intact
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.70]
3.28
normal use
operation including routine inspection and adjustments by any operator (3.29), and stand-by, according
to the instructions for use
Note 1 to entry: Normal use should not be confused with intended use (3.18). While both include the concept
of use as intended by the manufacturer, intended use (3.18) focuses on the medical purpose while normal use
incorporates not only the medical purpose, but maintenance, transport, etc. as well.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.71]
3.29
operator
per
...