SIST EN 60601-2-3:2015/A1:2016
(Amendment)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)
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)
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
Relations
Overview
EN 60601-2-3:2015/A1:2016 is the CENELEC adoption of IEC 60601-2-3:2012/A1:2016 and defines the particular requirements for the basic safety and essential performance of short-wave therapy medical electrical equipment. Published as an amendment (A1) to EN 60601-2-3:2015, the document harmonizes the European standard with the international amendment and clarifies references to the general IEC 60601-1 requirements. It supports conformity assessment under applicable EU directives and was approved for national adoption by CENELEC members.
Key identifiers: ICS 11.040.60 (Therapy equipment). The amendment updates normative references and editorial provisions without altering the core technical scope of the base publication.
Key Topics
- Scope and purpose: Reinforces that the standard applies to short-wave therapy devices and supplements the general requirements of IEC 60601-1 for medical electrical equipment.
- Normative reference alignment: Replaces references to "IEC 60601-1:2005" with the consolidated reference "IEC 60601-1" throughout the document to reflect current edition handling.
- Terminology and clauses: Updates clause headings and defined-term indexes (for example, the title for hazardous situations) to improve clarity on fault conditions specific to ME EQUIPMENT.
- Administrative and editorial changes: Includes foreword and introduction edits, and instructions for national implementation and withdrawal timelines under CENELEC rules.
These topics are presented to maintain consistency with international practice while ensuring the particular safety and performance needs of short-wave therapy systems are clearly framed.
Applications
The amendment and its parent standard are directly applicable to stakeholders involved with short-wave therapy devices, including:
- Manufacturers seeking to design and document compliance for short-wave therapy equipment.
- Test laboratories and conformity assessment bodies evaluating basic safety and essential performance.
- Clinical engineering teams and healthcare providers selecting or maintaining therapy devices.
- Regulatory and quality professionals preparing technical files or declarations of conformity.
Practical benefits include:
- Clearer normative links to general medical electrical safety requirements (IEC 60601-1).
- Improved consistency for documentation used in CE marking and national adoption.
- Guidance that helps demonstrate patient safety and device performance in clinical settings.
Related Standards
- IEC 60601-1 (General standard for basic safety and essential performance of medical electrical equipment)
- EN 60601-2-x series (other particular standards for specific therapeutic or diagnostic devices)
Notes: EN 60601-2-3:2015/A1:2016 is an amendment, not a full revision. Users should consult the base EN 60601-2-3:2015 text together with this amendment and check Annex ZZ for the relationship with EU directives (for example, medical device legislation references). For authoritative use, obtain the official CENELEC publication and national implementation texts.
Frequently Asked Questions
SIST EN 60601-2-3:2015/A1:2016 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "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)". This standard covers: 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)
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)
SIST EN 60601-2-3:2015/A1:2016 is classified under the following ICS (International Classification for Standards) categories: 11.040.60 - Therapy equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60601-2-3:2015/A1:2016 has the following relationships with other standards: It is inter standard links to SIST EN 60601-2-3:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60601-2-3:2015/A1:2016 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
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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
...
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