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 specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). This second edition cancels and replaces the first edition, published in 1987 and its Amendment 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012.

Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Stimulation von Nerven und Muskeln

Appareils électromédicaux - Partie 2-10: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs de nerfs et de muscles

La CEI 60601-2-10:2012 spécifie des exigences pour la sécurité de base et les performances essentielles des stimulateurs de nerfs et de muscles, utilisés dans la pratique de la médecine physique. Ceci comprend les neurostimulateurs électriques transcutanés (TENS) et les stimulateurs de muscles électriques (EMS). Cette deuxième édition annule et remplace la première édition parue en 1987 et son amendement 1 (2001). Elle constitue une révision technique et est alignée sur la CEI 60601-1:2005+A1:2012.

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

Ta mednarodni standard navaja zahteve za varnost živčnih in mišičnih STIMULATORJEV, opredeljenih v podpoglavju 201.3.204, za uporabo v fizični medicini (v nadaljevanju: ELEKTROMEDICINSKA OPREMA). To vključuje transkutane električne živčne STIMULATORJE (TENS) in električne mišične STIMULATORJE (EMS).
OPOMBA Mišični STIMULATOR se lahko imenuje tudi nevromišični STIMULATOR.
Izključena je naslednja ELEKTROMEDICINSKA OPREMA:
– ELEKTROMEDICINSKA OPREMA, namenjena vsaditvi ali priključitvi na vsajene elektrode;
– ELEKTROMEDICINSKA OPREMA, namenjena za stimulacijo možganov (tj. ELEKTROMEDICINSKA OPREMA za elektrokonvulzivno terapijo);
– ELEKTROMEDICINSKA OPREMA, namenjena nevrološkim raziskavam;
– zunanji srčni spodbujevalniki (glejte standard IEC 60601-2-31);
– ELEKTROMEDICINSKA OPREMA za diagnozo na podlagi povprečnih evociranih potencialov (glejte standard IEC 60601-2-40);
– ELEKTROMEDICINSKA OPREMA, namenjena elektromiografiji (glejte standard IEC 60601-2-40);
– ELEKTROMEDICINSKA OPREMA, namenjena defibrilaciji srca (glejte standard IEC 60601-2-4);

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 21-May-2018
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: 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)

Relations

• Replaces: EN 60601-2-10:2000 - Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-2-10:2000/A1:2001 - Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
• Effective Date: 28-Jan-2023
• Amended By: 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
• Effective Date: 23-Jan-2023
• Amended By: EN 60601-2-10:2015/A1:2016 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
• Effective Date: 10-Mar-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60601-2-10:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLåLYþQLKLQPLãLþQLKVWLPXODWRUMHY,(&
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)
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)
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)
Ta slovenski standard je istoveten z: EN 60601-2-10:2015
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

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.60 Supersedes EN 60601-2-10:2000
English Version
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)
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) Stimulation von Nerven und Muskeln
(IEC 60601-2-10:2012)
This European Standard was approved by CENELEC on 2012-07-09. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-10:2015 E
Foreword
The text of document 62D/1003/FDIS, future edition 2 of IEC 60601-2-10, prepared by IEC/SC 62 D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-10:2015.

The following dates are fixed:
• latest date by which the document has (dop) 2015-11-22
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-22
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-10:2000.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 60601-2-10:2012 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, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When 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.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Addition:
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+corrigendum Mar 2010
+AC 2014
+A11 2011
+A1 2012  +A1 2013
+A12 2014
Replacement:
IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: EN 60601-1-2 2007
(mod) General requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
+corrigendum Mar. 2010
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the
European Commission and the European Free Trade Association, and within its scope the
Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of
14 June 1993 concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling
within the scope of this standard.

IEC 60601-2-10 ®
Edition 2.0 2012-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 11.040.60 ISBN 978-2-83220-193-0

– 2 – 60601-2-10  IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions. 8
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents . 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 11
201.11 Protection against excessive temperatures and other HAZARDS . 11
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 11
201.13 HAZARDOUS SITUATIONS and fault conditions . 13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 13
201.15 Construction of ME EQUIPMENT . 13
201.16 ME SYSTEMS . 13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 13
202 Electromagnetic compatibility – Requirements and tests . 14
Annexes . 15
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 16
Annex AA (informative) Particular guidance and rationale . 17
Index of defined terms used in this particular standard. 20

Figure 202.101 – Testing layout . 15

Table 201.101 – Pulse frequency versus applied current limits . 13
Table 201.C.101 – Marking on the outside of STIMULATORS or their parts . 16

60601-2-10  IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
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