SIST EN IEC 61557-16:2025

Electrical safety in low voltage distribution systems up to 1 000 V AC and 1 500 V DC - Equipment for testing, measuring or monitoring of protective measures - Part 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment (IEC 61557-16:2023)

IEC 61557-16:2023 specifies the requirements applicable to the performance for test and measurement equipment in order to determine the effectiveness of the protective measures for electrical equipment and/or medical electrical equipment described in IEC 62353.
This International Standard is to be used in conjunction with IEC 61557-1:2019.
IEC 61557-16:2023 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) splitting of uncertainty requirements for medical and non-medical electrical equipment in 4.2.1;
b) addition of a definition of ranges with defined uncertainty in 4.2.1 to 4.2.7;
c) addition of an optional measuring device (MD) for non-medical devices in 4.2.1;
d) addition of a limitation of the maximum intrinsic uncertainty for medical applications at leakage current in 4.2.1;
e) change of 4.2.3 from test sockets to sockets for service purposes;
f) addition of a warning in the operating instructions;
g) integration of former 6.3 into 6.2;
h) update of Table 1;
i) alignment of the structure with that of the whole IEC 61557 series.

Elektrische Sicherheit in Niederspannungsnetzen bis AC 1 000 V und DC 1 500 V - Geräte zum Prüfen, Messen oder Überwachen von Schutzmaßnahmen - Teil 16: Geräte zur Prüfung der Wirksamkeit der Schutzmaßnahmen von elektrischen Geräten und/oder medizinisch elektrischen Geräten(IEC 61557-16:2023)

Sécurité électrique dans les réseaux de distribution basse tension de 1 000 V c.a. et 1 500 V c.c. - Dispositifs de contrôle, de mesure ou de surveillance de mesures de protection - Partie 16: Équipement pour les essais de bon fonctionnement des mesures de protection de l'équipement électrique et/ou de l'équipement médical électrique (IEC 61557-16:2023)

L'IEC 61557-16:2023 spécifie les exigences de performance applicables pour les dispositifs de contrôle et de mesure afin de déterminer le bon fonctionnement des mesures de protection des appareils électriques et/ou des appareils électromédicaux décrits dans l’IEC 62353.
L'IEC 61557-16:2023 annule et remplace la première édition parue en 2014. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente:
a) séparation des exigences d’incertitude pour les appareils électromédicaux et électriques non médicaux en 4.2.1;
b) ajout d’une définition de plages avec une incertitude définie de 4.2.1 à 4.2.7;
c) ajout d’un dispositif de mesure (DM) facultatif pour les appareils non médicaux en 4.2.1;
d) ajout d’une limitation de l’incertitude intrinsèque maximale pour les applications médicales au niveau du courant de fuite en 4.2.1;
e) changement en 4.2.3 de "prises de courant d’essai" en "prises de courant pour des besoins de service";
f) ajout d’un avertissement dans les instructions de fonctionnement;
g) intégration de l’ancien 6.3 en 6.2;
h) mise à jour du Tableau 1;
i) alignement de la structure sur celle de l’ensemble de la série IEC 61557.

Električna varnost v nizkonapetostnih razdelilnih sistemih za izmenične napetosti do 1 kV in enosmerne napetosti do 1,5 kV - Oprema za preskušanje, merjenje ali nadzorovanje zaščitnih ukrepov - 16. del: Oprema za preskušanje učinkovitosti zaščitnih ukrepov električne opreme oziroma medicinske električne opreme (IEC 61557-16:2023)

General Information

• Status: Published
• Public Enquiry End Date: 30-Jul-2022
• Publication Date: 14-Jan-2025
• ICS: 17.220.20 - Measurement of electrical and magnetic quantities
• ICS: 29.080.01 - Electrical insulation in general
• ICS: 29.240.01 - Power transmission and distribution networks in general
• Technical Committee: MOV - Measuring equipment for electromagnetic quantities
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 17-Dec-2024
• Due Date: 21-Feb-2025
• Completion Date: 15-Jan-2025
• Directive: 2014/35/EU - Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
• Mandate: M/511 - Mandate to CEN, CENELEC and ETSI relating to harmonised standards in the field of the Low Voltage Directive
• Ref Project: EN IEC 61557-16:2024 - Electrical safety in low voltage distribution systems up to 1 000 V AC and 1 500 V DC - Equipment for testing, measuring or monitoring of protective measures - Part 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment

Relations

• Revised: SIST EN 61557-16:2015 - Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment (IEC 61557-16:2014)
• Effective Date: 06-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2025
Električna varnost v nizkonapetostnih razdelilnih sistemih za izmenične napetosti
do 1 kV in enosmerne napetosti do 1,5 kV - Oprema za preskušanje, merjenje ali
nadzorovanje zaščitnih ukrepov - 16. del: Oprema za preskušanje učinkovitosti
zaščitnih ukrepov električne opreme oziroma medicinske električne opreme (IEC
61557-16:2023)
Electrical safety in low voltage distribution systems up to 1 000 V AC and 1 500 V DC -
Equipment for testing, measuring or monitoring of protective measures - Part 16:
Equipment for testing the effectiveness of the protective measures of electrical
equipment and/or medical electrical equipment (IEC 61557-16:2023)
Elektrische Sicherheit in Niederspannungsnetzen bis AC 1 000 V und DC 1 500 V -
Geräte zum Prüfen, Messen oder Überwachen von Schutzmaßnahmen - Teil 16: Geräte
zur Prüfung der Wirksamkeit der Schutzmaßnahmen von elektrischen Geräten und/oder
medizinisch elektrischen Geräten(IEC 61557-16:2023)
Sécurité électrique dans les réseaux de distribution basse tension de 1 000 V c.a. et 1
500 V c.c. - Dispositifs de contrôle, de mesure ou de surveillance de mesures de
protection - Partie 16: Équipement pour les essais de bon fonctionnement des mesures
de protection de l'équipement électrique et/ou de l'équipement médical électrique (IEC
61557-16:2023)
Ta slovenski standard je istoveten z: EN IEC 61557-16:2024
ICS:
17.220.20 Merjenje električnih in Measurement of electrical
magnetnih veličin and magnetic quantities
29.080.01 Električna izolacija na Electrical insulation in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61557-16

NORME EUROPÉENNE
EUROPÄISCHE NORM December 2024
ICS 17.220.20; 29.080.01 Supersedes EN 61557-16:2015
English Version
Electrical safety in low voltage distribution systems up to 1 000 V
AC and 1 500 V DC - Equipment for testing, measuring or
monitoring of protective measures - Part 16: Equipment for
testing the effectiveness of the protective measures of electrical
equipment and/or medical electrical equipment
(IEC 61557-16:2023)
Sécurité électrique dans les réseaux de distribution basse Elektrische Sicherheit in Niederspannungsnetzen bis AC 1
tension au plus égale à 1 000 V en courant alternatif et 1 000 V und DC 1 500 V - Geräte zum Prüfen, Messen oder
500 V en courant continu - Dispositifs de contrôle, de Überwachen von Schutzmaßnahmen - Teil 16: Geräte zur
mesure ou de surveillance de mesures de protection - Prüfung der Wirksamkeit der Schutzmaßnahmen von
Partie 16: Équipement pour les essais de bon elektrischen Geräten und/oder medizinisch elektrischen
fonctionnement des mesures de protection des appareils Geräten
électriques et/ou des appareils électromédicaux (IEC 61557-16:2023)
(IEC 61557-16:2023)
This European Standard was approved by CENELEC on 2024-10-16. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61557-16:2024 E

European foreword
The text of document 85/876/FDIS, future edition 2 of IEC 61557-16, prepared by TC 85 "Measuring
equipment for electrical and electromagnetic quantities" was submitted to the IEC-CENELEC parallel
vote and approved by CENELEC as EN IEC 61557-16:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-12-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-12-31
document have to be withdrawn
This document supersedes EN 61557-16:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN IEC 61557-1:2021.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61557-16:2023 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60990 NOTE Approved as EN 60990
IEC 61000-4-8 NOTE Approved as EN 61000-4-8
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60529 - Degrees of protection provided by EN 60529 -
enclosures (IP Code)
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - +AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 61010-1 2010 Safety requirements for electrical EN 61010-1 2010
equipment for measurement, control, and
laboratory use - Part 1: General
requirements
+ A1 (mod) 2016 + A1 2019
- - + AC 2019
IEC 61010-031 - Safety requirements for electrical EN IEC 61010-031 -
equipment for measurement, control, and
laboratory use - Part 031: Safety
requirements for hand-held and hand-
manipulated probe assemblies for
electrical test and measurement
IEC 61010-2-030 - Safety requirements for electrical EN IEC 61010-2- -
equipment for measurement, control, and 030
laboratory use - Part 2-030: Particular
requirements for equipment having testing
or measuring circuits
Publication Year Title EN/HD Year
IEC 61010-2-032 - Safety requirements for electrical EN 61010-2-032 -
equipment for measurement, control, and
laboratory use - Part 2-032: Particular
requirements for hand-held and hand-
manipulated current sensors for electrical
test and measurement
IEC 61010-2-034 - Safety requirements for electrical EN 61010-2-034 -
equipment for measurement, control, and
laboratory use - Part 2-034: Particular
requirements for measurement equipment
for insulation resistance and test
equipment for electric strength
IEC 61557-1 2019 Electrical safety in low voltage distribution EN IEC 61557-1 2021
systems up to 1 000 V AC and 1 500 V DC
- Equipment for testing, measuring or
monitoring of protective measures - Part 1:
General requirements
IEC 61557-2 - Electrical safety in low voltage distribution EN IEC 61557-2 -
systems up to 1 000 V AC and 1 500 V DC
- Equipment for testing, measuring or
monitoring of protective measures - Part 2:
Insulation resistance
IEC 61557-4 - Electrical safety in low voltage distribution EN IEC 61557-4 -
systems up to 1 000 V AC and 1 500 V DC
- Equipment for testing, measuring or
monitoring of protective measures - Part 4:
Resistance of earth connection and
equipotential bonding
IEC 61557-10 - Electrical safety in low voltage distribution EN IEC 61557-10 -
systems up to 1 000 V AC and 1 500 V DC
- Equipment for testing, measuring or
monitoring of protective measures - Part
10: Combined measuring equipment
IEC 61557-13 - Electrical safety in low voltage distribution EN IEC 61557-13 -
systems up to 1 000 V AC and 1 500 V DC
- Equipment for testing, measuring or
monitoring of protective measures - Part
13: Hand-held and hand-manipulated
current clamps and sensors for
measurement of leakage currents in
electrical distribution systems
IEC 62353 2014 Medical electrical equipment - Recurrent EN 62353 2014
test and test after repair of medical
electrical equipment
IEC 61557-16 ®
Edition 2.0 2023-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electrical safety in low voltage distribution systems up to 1 000 V AC and

1 500 V DC – Equipment for testing, measuring or monitoring of protective

measures –
Part 16: Equipment for testing the effectiveness of the protective measures of

electrical equipment and/or medical electrical equipment

Sécurité électrique dans les réseaux de distribution basse tension au plus

égale à 1 000 V en courant alternatif et 1 500 V en courant continu – Dispositifs

de contrôle, de mesure ou de surveillance de mesures de protection –

Partie 16: Équipement pour les essais de bon fonctionnement des mesures de

protection des appareils électriques et/ou des appareils électromédicaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.220.20, 29.080.01 ISBN 978-2-8322-7251-0

– 2 – IEC 61557-16:2023 © IEC 2023
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements . 9
4.1 General requirements . 9
4.2 Measuring functions . 9
4.2.1 Minimum measuring function requirements . 9
4.2.2 Measurement of the resistance of the protective bonding or the
protective earth resistance . 10
4.2.3 Measurement of insulation resistance . 10
4.2.4 Measurement of protective conductor current or equipment leakage
current with the alternative method . 11
4.2.5 Measurement of touch current, patient leakage current and applied part
leakage current with the alternative method . 11
4.2.6 Measurement of protective conductor current and equipment leakage
current with the direct or differential (residual) method . 12
4.2.7 Measurement of touch current, patient leakage current and applied part
leakage current with the direct or differential (residual) method . 13
4.3 Construction requirements . 13
4.3.1 Overvoltage capability . 13
4.3.2 Terminals . 13
4.3.3 Sockets for service purpose . 14
4.3.4 Degree of protection . 14
4.3.5 Class of protection . 14
4.3.6 Overvoltage and measurement categories . 14
4.3.7 Accessories . 14
5 Markings and operating instructions . 15
...