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

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

Medicinska električna oprema - 2-10. del: Posebne zahteve za osnovno varnost in bistvene lastnosti živčnih in mišičnih stimulatorjev - Dopolnilo A1 (IEC 60601-2-10:2012/A1:2016)

General Information

• Status: Published
• Publication Date: 15-Dec-2016
• Withdrawal Date: 15-Dec-2019
• 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: 16-Dec-2016
• Completion Date: 16-Dec-2016
• 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/A1:2017 - 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/A1:2016)

Relations

• Amends: 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
• Effective Date: 10-Mar-2015

Overview

EN 60601-2-10:2015/A1:2016 (equivalent to IEC 60601-2-10:2012/A1:2016) is a European amendment that sets the particular requirements for basic safety and essential performance of nerve and muscle stimulators - a subset of medical electrical equipment used in therapy and diagnostics. Published by CENELEC and adopted nationally, the amendment updates references, terminology and specific collateral requirements to align the particular standard with the current IEC 60601 series and EU regulatory framework.

Key topics and requirements

• Scope and objective: Establishes particular safety and performance criteria that complement the general IEC 60601-1 requirements for medical electrical equipment used to stimulate nerves and muscles.
• Basic safety and essential performance: Requirements address risks specific to stimulators (design, outputs, protection measures) and ensure the device performs as intended without causing unacceptable risk.
• Usability: Clause title updated to Usability of ME EQUIPMENT, emphasizing human factors that reduce use-related hazards for operators and patients.
• Hazardous situations and fault conditions: Defines how to identify and mitigate hazardous situations and faults specific to nerve and muscle stimulators.
• Electromagnetic compatibility (EMC): Amendment renames the collateral clause to Electromagnetic disturbances – requirements and tests (aligning with IEC 60601-1-2). It explicitly addresses patient‑coupled cables, their emissions/tests (e.g., patient‑coupled cable tests) and termination of patient‑coupled parts.
• Normative references: Updates references to the core standards (now cited as IEC 60601-1 and IEC 60601-1-2) and aligns Annex ZA for EU directives and harmonization.
• Regulatory alignment: Supports essential requirements of EU medical device directives (notably referenced informative Annex ZZ for 93/42/EEC in the base standard).

Applications and users

Who uses this standard:

• Medical device manufacturers designing nerve and muscle stimulators
• Compliance and regulatory affairs teams preparing technical files and CE marking evidence
• Test laboratories and conformity assessment bodies performing safety, EMC and usability testing
• Clinical engineers and procurement teams assessing device safety and performance specifications Practical uses:
• Product design guidance and risk management for stimulators
• Defining test plans for safety, EMC and usability
• Demonstrating conformity with EU and IEC medical electrical equipment requirements

Related standards

• IEC 60601-1 - General requirements for basic safety and essential performance (referenced norm)
• IEC 60601-1-2 / EN 60601-1-2 - Electromagnetic disturbances - requirements and tests (EMC)
• EN 60601-2-10:2015 (base particular standard) and its Annex ZA for regulatory mapping

Keywords: EN 60601-2-10, IEC 60601-2-10 A1 2016, nerve and muscle stimulators standard, medical electrical equipment, essential performance, safety, EMC, patient-coupled cables, IEC 60601-1.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2017
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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/A1:2016)
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
Ta slovenski standard je istoveten z: EN 60601-2-10:2015/A1:2016
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/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2016
ICS 11.040.60
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/A1:2016)
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/A1:2016) Stimulation von Nerven und Muskeln
(IEC 60601-2-10:2012/A1:2016)
This amendment A1 modifies the European Standard EN 60601-2-10:2015; it was approved by CENELEC on 2016-06-03. 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, 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
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-10:2015/A1:2016 E

European foreword
The text of document 62D/1332/FDIS, future IEC 60601-2-10:2012/A1, prepared by SC 62D
"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/A1:2016.
The following dates are fixed:
(dop) 2017-06-16
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2019-12-16
• latest date by which the national standards conflicting with
the 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 [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 93/42/EEC, see informative Annex ZZ, included in
EN 60601-2-10:2015.
Endorsement notice
The text of the International Standard IEC 60601-2-10:2012/A1:2016 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 r
...