SIST EN 60601-2-3:2015/A1:2016

Medizinische elektrische Geräte - Teil 2-3: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Kurzwellen-Therapiegeräten (IEC 60601-2-3:2012/A1:2016)

Appareils électromédicaux - Partie 2-3: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à ondes courtes (IEC 60601-2-3:2012/A1:2016)

Medicinska električna oprema - 2-3. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za opremo za kratkovalovno terapijo - Predlagani horizontalni standardi - Dopolnilo A1 (IEC 60601-2-3:2012/A1:2016)

General Information

• Status: Published
• Publication Date: 19-Oct-2016
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Oct-2016
• Due Date: 10-Dec-2016
• Completion Date: 20-Oct-2016
• Directive: Not Harmonized93/42/EEC - Medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-3:2015/A1:2016 - Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

Relations

• Referred By: SIST EN 1789:2007+A1:2010 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 09-Feb-2026
• Referred By: SIST EN 1789:2007+A2:2015 - Medical vehicles and their equipment - Road ambulances
• Effective Date: 09-Feb-2026
• Referred By: SIST EN 13718-1:2008 - Medical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances
• Effective Date: 09-Feb-2026
• Amends: SIST EN 60601-2-3:2015 - Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
• Effective Date: 10-Mar-2015

Overview

SIST EN 60601-2-3:2015/A1:2016 is a European standard that specifies particular requirements for the basic safety and essential performance of short-wave therapy equipment, as part of the broader IEC 60601 family. This amendment (A1:2016) enhances the 2015 edition and aligns it with updates and terminology harmonization found in IEC 60601-2-3:2012/A1:2016. The standard is vital for organizations involved in the design, manufacture, testing, and certification of medical electrical equipment, particularly devices used for short-wave therapy.

Compliance with SIST EN 60601-2-3:2015/A1:2016 is crucial for meeting European regulatory requirements, supporting the implementation of EU medical device directives, and ensuring patient and user safety in medical settings.

Key Topics

• Basic Safety Requirements: Details the essential safety criteria that short-wave therapy equipment must fulfill to minimize risks to patients and medical staff.
• Essential Performance: Defines the functional performance standards necessary to ensure the therapeutic effectiveness of the equipment under normal and fault conditions.
• Hazardous Situations and Fault Conditions: Updates terminology and subclause headings for clarity regarding the management and assessment of hazardous situations in medical electrical equipment (ME equipment).
• Reference to General Standard IEC 60601-1: Ensures alignment with IEC 60601-1 terminology and requirements, providing a consistent framework for safety and performance assessment.
• Regulatory Alignment: Supports compliance with the EU's Medical Device Directive 93/42/EEC, helping manufacturers ensure that their products meet European market requirements.

Applications

• Medical Device Manufacturers: Guidance for the design and development of short-wave therapy equipment, ensuring products satisfy both international and European safety and performance requirements.
• Test Laboratories and Certification Bodies: Reference for verifying that short-wave therapy equipment meets the specific safety and essential performance criteria outlined in the standard.
• Healthcare Facilities: Basis for procurement decisions and risk management when acquiring and using short-wave therapy equipment, ensuring high standards of patient and operator safety.
• Regulatory Authorities: Reference point for assessing the conformity of medical electrical equipment in accordance with EU directives and international best practices.

Related Standards

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment - the foundational standard referenced throughout.
• EN 60601-2-3:2015: The base European standard for short-wave therapy equipment, amended by this document.
• IEC 60601-2-3:2012: International version outlining safety performance for short-wave therapy devices.
• Medical Device Directive 93/42/EEC: The European regulatory framework supported by this standard for conformity assessment and CE marking of medical devices.
• ICS 11.040.60: Refers to the International Classification for Standards group relevant to therapy equipment.

By applying SIST EN 60601-2-3:2015/A1:2016, manufacturers and stakeholders can ensure that short-wave therapy equipment meets current European expectations for safety, performance, and market access. This standard is a key resource for anyone involved in the life cycle of medical electrical equipment used in therapeutic applications.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2016
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Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and
essential performance of short-wave therapy equipment - Proposed Horizontal Standard
(IEC 60601-2-3:2012/A1:2016)
Medizinische elektrische Geräte - Teil 2-3: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Kurzwellen-Therapiegeräten
(IEC 60601-2-3:2012/A1:2016)
Appareils électromédicaux - Partie 2-3: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de thérapie à ondes courtes (IEC 60601-2
-3:2012/A1:2016)
Ta slovenski standard je istoveten z: EN 60601-2-3:2015/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 60601-2-3:2015/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2016
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-3: Particular requirements
for the basic safety and essential performance of short-wave
therapy equipment
(IEC 60601-2-3:2012/A1:2016)
Appareils électromédicaux - Partie 2-3: Exigences Medizinische elektrische Geräte - Teil 2-3: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de thérapie à ondes courtes wesentlichen Leistungsmerkmale von Kurzwellen-
(IEC 60601-2-3:2012/A1:2016) Therapiegeräten
(IEC 60601-2-3:2012/A1:2016)
This amendment A1 modifies the European Standard EN 60601-2-3:2015; 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 60601-2-3:2015/A1:2016 E

European foreword
The text of document 62D/1330/FDIS, future IEC 60601-2-3:2012/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 C
...