SIST EN 60601-2-33:2010/A1:2015

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik

Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical

Medicinska električna oprema - 2-33. del: Posebne zahteve za varnost opreme za magnetno resonanco za medicinsko diagnostiko - Dopolnilo A1

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MR OPREME in MR SISTEMOV, v nadaljevanju ME OPREME. Ta standard ne zajema uporabo MR OPREME zunaj PREDVIDENE UPORABE. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru tako klavzula ali podklavzula veljata za ustrezno ME OPREMO in ME SISTEME.

General Information

• Status: Published
• Publication Date: 13-Aug-2015
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 14-Aug-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: EN 60601-2-33:2010/A1:2015 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Relations

• Replaced By: SIST EN IEC 60601-2-33:2024 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2022)
• Effective Date: 01-Nov-2024
• Amends: SIST EN 60601-2-33:2010 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
• Effective Date: 01-Sep-2015

Overview

EN 60601-2-33:2010/A1:2015 is the CENELEC-endorsed amendment to the European medical electrical equipment standard that defines particular requirements for the basic safety and essential performance of magnetic resonance (MR/MRI) equipment for medical diagnosis. Approved in April 2015 and published as an amendment to EN 60601-2-33:2010, this document aligns MR-specific requirements with the amendments introduced in IEC 60601-1:2005+A1:2012.

This amendment clarifies the scope and application of MR safety provisions and provides manufacturers and compliance teams with updated instructions for use, marking, and technical descriptions relevant to MR systems and MR equipment.

Key Topics

• Scope and exclusions: The amendment notes that specific requirements are not formulated for MR equipment used in interventional MR examinations.
• Harmonization with IEC 60601-1+A1: References to IEC 60601-1:2005 are updated to include Amendment 1:2012 to ensure consistency with general medical electrical equipment requirements.
• Marking and signage: Specifies applicable safety signs (ISO 7010-W005, W006 and ISO 7010-M003) and positioning for Controlled Access Areas; manufacturers must document signage needs in the risk management file and instructions for use.
• Instructions for use: Expanded requirements include acoustic-noise guidance (referencing NEMA MS 4:2010), pregnancy-related precautions (advising caution in first trimester and recommending RIS integration), and measures to limit patient core temperature rise (see Table 201.104 in the standard for applicable limit references).
• Environmental and mechanical provisions: Clarifies humidity preconditioning for equipment used in controlled environments and removes certain dynamic force test requirements that are not applicable to MR patient tables.
• Technical description requirements: Manufacturers must include compatibility technical specification sheets, recurrent basic safety testing guidance, and details on electromagnetic field information in the technical description.

Applications

This amendment is essential for:

• MR system and MR equipment manufacturers preparing CE marking documentation
• Regulatory and compliance teams ensuring conformity with EU directives (informative Annex ZZ relationship to Directive 93/42/EEC is referenced)
• Clinical engineers and hospital procurement teams assessing safety labeling, acoustic and EMF guidance
• Risk management and instructions-for-use authors who must address pregnancy, thermal and acoustic patient safety

Practical benefits: clearer signage and labeling expectations, harmonized collateral standard references, and enhanced instructions for use supporting safer MR operation and regulatory compliance.

Related Standards

• IEC 60601-1:2005 + A1:2012 (general requirements for medical electrical equipment)
• NEMA MS 4:2010 (acoustic noise measurement for diagnostic MRI devices)
• ISO 7010:2011 (graphical symbols - registered safety signs)

For implementation dates, CENELEC fixed the date of publication and national adoption; contact the CENELEC Management Centre or national committee for national-status updates and bibliographic references.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DYDUQRVWRSUHPH]D
PDJQHWQRUHVRQDQFR]DPHGLFLQVNRGLDJQRVWLNR'RSROQLOR$
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and
essential performance of magnetic resonance equipment for medical diagnosis
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
von Magnetresonanzgeräten für die medizinische Diagnostik
Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à résonance magnétique utilisés pour le
diagnostic médical
Ta slovenski standard je istoveten z: EN 60601-2-33:2010/A1:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-33:2010/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.55
English Version
Medical electrical equipment - Part 2-33: Particular requirements
for the basic safety and essential performance of magnetic
resonance equipment for medical diagnosis
(IEC 60601-2-33:2010/A1:2013)
Appareils électromédicaux - Partie 2-33: Exigences Medizinische elektrische Geräte - Teil 2-33: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit von
essentielles des appareils à résonance magnétique utilisés Magnetresonanzgeräten für die medizinische Diagnostik
pour le diagnostic médical (IEC 60601-2-33:2010/A1:2013)
(IEC 60601-2-33:2010/A1:2013)
This amendment A1 modifies the European Standard EN 60601-2-33:2010; it was approved by CENELEC on 2015-04-14. 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
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-33:2010/A1:2015 E

Foreword
The text of document 62B/884/CDV, future IEC 60601-2-33:2010/A1, prepared by SC 62B "Diagnostic
imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the
IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-33:2010/A1:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
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.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 60601-2-33:2010/A11:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-33:2010/A1:2013 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-33:2010, the following note has to be added for the standard
indicated:
ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012 (not modified).
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
Replacements in Annex ZA of EN 60601-2-33:2010:

Publication Year Title EN/HD Year
Replace the existing reference to IEC 60601-1:2005 by the following:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance
+A1 2012  +A1 2013
+A1/AC 2014
+A12 2014
Replace the existing reference to NEMA MS 4:2006 by the following:
NEMA MS 4 2010 Acoustic noise measurement procedure for - -
diagnostic Magnetic Resonance Imaging
(MRI) devices
IEC 60601-2-33 ®
Edition 3.0 2013-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 2-33: Particular requirements for the basic safety and essential performance

of magnetic resonance equipment for medical diagnosis

Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils à résonance magnétique utilisés pour le diagnostic

médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX G
ICS 11.040.55 ISBN 978-2-83220-751-2

– 2 – 60601-2-33 Amend.1 © IEC:2013
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the follo
...