SIST EN 60601-2-6:2015/A1:2016

Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment - Proposed Horizontal Standard (IEC 60601-2-6:2012/A1:2016)

Medizinische elektrische Geräte - Teil 2-6: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Mikrowellen-Therapiegeräten (IEC 60601-2-6:2012/A1:2016)

Appareils électromédicaux - Partie 2-6: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à micro-ondes (IEC 60601-2-6:2012/A1:2016)

Medicinska električna oprema - 2-6. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za mikrovalovno terapijo - Predlagani horizontalni standard - Dopolnilo A1 (IEC 60601-2-6:2012/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: 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: EN 60601-2-6:2015/A1:2016 - Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

Relations

• Amends: SIST EN 60601-2-6:2015 - Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
• Effective Date: 10-Mar-2015

Overview

EN 60601-2-6:2015/A1:2016 (aligned with IEC 60601-2-6:2012/A1:2016) is a European amendment that specifies the particular requirements for the basic safety and essential performance of microwave therapy equipment. It updates the EN/IEC 60601-2-6 series to align references and terminology with the general medical electrical equipment standard (IEC 60601-1) and clarifies safety, performance, and electromagnetic disturbance requirements for microwave therapeutic devices.

Key administrative notes in the amendment:

• Approved by CENELEC (June 2016) and published December 2016.
• Contains editorial and normative changes (clause titles, references to IEC 60601-1).
• Supports conformity assessment under EU medical device requirements (informative Annex ZZ for relationship with Directive 93/42/EEC).

Key Topics

This amendment addresses technical and normative topics including:

• Basic safety and essential performance criteria specific to microwave therapy equipment.
• Indication relevant to safety: clarification of how parameters and controls that affect safety should be indicated to users.
• Hazardous situations and fault conditions: renaming and emphasis on hazardous situations for medical electrical (ME) equipment.
• Electromagnetic disturbances / EMC: requirements and test methods for electromagnetic compatibility (formerly listed as “Electromagnetic compatibility – Requirements and tests” and updated to “Electromagnetic disturbances – requirements and tests”).
• Test conditions and setup: clarification and renumbering of general test conditions and test setup clauses.
• Terminology alignment: harmonization of defined terms and cross-references with IEC 60601-1.

Applications

EN 60601-2-6:2015/A1:2016 is applied where safety and performance of microwave therapy devices must be demonstrated:

• Device design and development - to define safety features, user controls, and performance limits.
• Type and conformity testing - for laboratory test specifications related to electromagnetic disturbances and functional safety.
• Risk management and clinical evaluation - to identify hazardous situations and fault conditions specific to microwave therapy.
• Regulatory compliance and CE marking - used by manufacturers and notified bodies to support conformity assessment in Europe.
• Procurement and maintenance - to set acceptance criteria and periodic test requirements for clinical users and biomedical engineering teams.

Who Uses This Standard

• Medical electrical equipment manufacturers (R&D, compliance)
• Test laboratories and certification bodies
• Notified bodies and regulators
• Clinical engineers and hospital procurement teams
• Product safety and regulatory affairs professionals

Related Standards

• IEC 60601-1 (general requirements for basic safety and essential performance)
• IEC 60601-1-2 (electromagnetic compatibility / electromagnetic disturbances)
• EU medical device directives (informative Annex ZZ references relationship with 93/42/EEC)

Keywords: EN 60601-2-6:2015/A1:2016, IEC 60601-2-6, microwave therapy equipment, medical electrical equipment safety, essential performance, electromagnetic disturbances, EMC testing, CENELEC.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2016
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Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and
essential performance of microwave therapy equipment - Proposed Horizontal Standard
(IEC 60601-2-6:2012/A1:2016)
Medizinische elektrische Geräte - Teil 2-6: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Mikrowellen-Therapiegeräten
(IEC 60601-2-6:2012/A1:2016)
Appareils électromédicaux - Partie 2-6: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de thérapie à micro-ondes (IEC 60601-2-
6:2012/A1:2016)
Ta slovenski standard je istoveten z: EN 60601-2-6:2015/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 60601-2-6:2015/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2016
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-6: Particular requirements
for the basic safety and essential performance of microwave
therapy equipment
(IEC 60601-2-6:2012/A1:2016)
Appareils électromédicaux - Partie 2-6: Exigences Medizinische elektrische Geräte - Teil 2-6: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de thérapie à micro-ondes wesentlichen Leistungsmerkmale von Mikrowellen-
(IEC 60601-2-6:2012/A1:2016) Therapiegeräten
(IEC 60601-2-6:2012/A1:2016)
This amendment A1 modifies the European Standard EN 60601-2-6:2015; 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 60601-2-6:2015/A1:2016 E

European foreword
The text of document 62D/1331/FDIS, future IEC 60601-2-6:2012/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 60601-2-6:2015/A1:2016.
The following dates are fixed:
(dop) 2017-03-30
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2019-09-30
• latest date by which the national standards conflicting with
the document have to be withdrawn

Attention is drawn to t
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