SIST EN 60601-2-10:2015/A2:2024

Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012/AMD2:2023)

Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Stimulation von Nerven und Muskeln (IEC 60601-2-10:2012/AMD2:2023)

Appareils électromédicaux - Partie 2-10: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs de nerfs et de muscles (IEC 60601-2-10:2012/AMD2:2023)

Medicinska električna oprema - 2-10. del: Posebne zahteve za osnovno varnost in bistvene lastnosti živčnih in mišičnih stimulatorjev - Dopolnilo A2 (IEC 60601-2-10:2012/AMD2:2023)

General Information

• Status: Published
• Publication Date: 03-Oct-2024
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Sep-2024
• Due Date: 30-Nov-2024
• Completion Date: 04-Oct-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: EN 60601-2-10:2015/A2:2024 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Relations

• Amends: SIST EN 60601-2-10:2015 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012)
• Effective Date: 27-Apr-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-10. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti živčnih in mišičnih stimulatorjev - Dopolnilo A2 (IEC 60601-2-
10:2012/AMD2:2023)
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and
essential performance of nerve and muscle stimulators (IEC 60601-2-
10:2012/AMD2:2023)
Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Stimulation von
Nerven und Muskeln (IEC 60601-2-10:2012/AMD2:2023)
Appareils électromédicaux - Partie 2-10: Exigences particulières pour la sécurité de base
et les performances essentielles des stimulateurs de nerfs et de muscles (IEC 60601-2-
10:2012/AMD2:2023)
Ta slovenski standard je istoveten z: EN 60601-2-10:2015/A2:2024
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-10:2015/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
ICS 11.040.60
English Version
Amendment 2 - Medical electrical equipment - Part 2-10:
Particular requirements for the basic safety and essential
performance of nerve and muscle stimulators
(IEC 60601-2-10:2012/AMD2:2023)
Appareils électromédicaux - Partie 2-10: Exigences Medizinische elektrische Geräte - Teil 2-10: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des stimulateurs de nerfs et de muscles wesentlichen Leistungsmerkmale von Geräten zur
(IEC 60601-2-10:2012/AMD2:2023) Stimulation von Nerven und Muskeln
(IEC 60601-2-10:2012/AMD2:2023)
This amendment A2 modifies the European Standard EN 60601-2-10:2015; it was approved by CENELEC on 2024-07-31. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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 60601-2-10:2015/A2:2024 E

European foreword
The text of document 62D/2004/FDIS, future edition 2 of IEC 60601-2-10/AMD2, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-07-31
document have to be withdrawn
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.
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 60601-2-10:2012/AMD2:2023 was approved by CENELEC
as a European Standard without any modification.
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.
Replace:
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020 + A1 2021
Add:
Publication Year Title EN/HD Year
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 60601-2-10 ®
Edition 2.0 2023-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –

Part 2-10: Particular requirements for the basic safety and essential performance

of nerve and muscle stimulators

Appareils électromédicaux –
Partie 2-10: Exigences particulières pour la sécurité de base et les performances

essentielles des stimulateurs de nerfs et de muscles

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-6342-6

– 2 – IEC 60601-2-10:2012/AMD2:2023
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-10: Particular requirements for the basic safety and
essential performance of nerve and muscle stimulators

AMENDMENT 2
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The
...