SIST EN 60601-2-33:2010/A1:2015
(Amendment)Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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
- 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
- Not Harmonized93/42/EEC - Medical devicesOJ Ref: C 389 OJ Date: 17-Nov-2017 Conflicting Date: 14-Apr-2018
Relations
- Effective Date
- 01-Nov-2024
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 01-Sep-2015
Overview
SIST EN 60601-2-33:2010/A1:2015 is a European amendment to the international standard that specifies particular requirements for the basic safety and essential performance of magnetic resonance (MR) equipment used for medical diagnosis. Issued by the Slovenian Institute for Standardization (SIST), this standard is identical to EN 60601-2-33:2010/A1:2015 and directly aligns with IEC 60601-2-33:2010/A1:2013.
Focused on MR equipment and MR systems for their intended diagnostic use in healthcare, the standard ensures these sophisticated devices meet strict criteria for patient and operator safety, electromagnetic compatibility, and performance reliability. This amendment harmonizes the main standard with technical corrections, updated safety references, and the latest requirements for marking and documentation, further supporting regulatory compliance within the European market.
Key Topics
- Basic Safety Requirements
- Defines processes and checks to prevent harm to patients and medical personnel.
- Updated to reference IEC 60601-1:2005+A1:2012 for general safety requirements.
- Essential Performance
- Addresses the performance aspects critical to the intended safety and function of MR equipment.
- Risk management guidance recommends identifying and documenting essential performance in line with manufacturer risk management files.
- Labeling, Documentation, and Instructions for Use
- Specifies the use of relevant safety signs (ISO 7010 W005, W006, M003) at controlled access areas.
- Provides detailed user instructions concerning physiological effects, acoustic noise, and specific populations such as pregnant patients.
- Requires updated technical documentation and compatibility specification sheets.
- Environmental Considerations
- Allows for omission of humidity preconditioning in controlled environments as specified by the manufacturer.
- Patient and Operator Safety
- Addresses exposure to electromagnetic fields, including recommendations for warning systems during pregnancy and protective measures against acoustic noise.
- Highlights limits for patient core temperature and tissue safety during MR procedures.
- Scope Limits
- Excludes interventional uses of MR equipment and focuses strictly on intended diagnostic functions.
Applications
The standard applies to manufacturers, suppliers, and healthcare facilities involved in the production, selection, and operation of medical magnetic resonance imaging (MRI) equipment. Key applications include:
- Design and Manufacturing: Ensures that MR devices are developed with comprehensive safety features and performance checks, reducing risk in clinical environments.
- Regulatory Compliance: Enables manufacturers to demonstrate conformity with EU directives and international market requirements, accelerating product approvals.
- Procurement and Installation: Assists hospitals, clinics, and imaging centers in evaluating MR systems for safety, labeling, and documentation compliance.
- Clinical Operation and Maintenance: Provides essential guidelines for safe operation, regular safety testing, and correct response to hazards such as acoustic noise or electromagnetic emissions.
- User Awareness: Enhances patient and staff safety through clear marking of danger zones and transparent communication about physiological risks.
Related Standards
To fully implement SIST EN 60601-2-33:2010/A1:2015, familiarity with the following standards is recommended:
- IEC 60601-1:2005+A1:2012 (EN 60601-1:2006+A1:2013): General requirements for basic safety and essential performance of medical electrical equipment.
- NEMA MS 4:2010: Acoustic noise measurement procedures for MRI devices.
- ISO 7010:2011 (EN ISO 7010:2012): Graphical symbols - Safety signs for marking danger and warning areas relevant to MR environments.
- Collateral Standards in the IEC 60601-1 Series: Particularly those referenced directly for electronic and EMC safety.
By adhering to SIST EN 60601-2-33:2010/A1:2015, organizations contribute to the highest levels of MR system safety, operational excellence, and regulatory integrity in medical imaging.
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Frequently Asked Questions
SIST EN 60601-2-33:2010/A1:2015 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis". This standard covers: 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.
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.
SIST EN 60601-2-33:2010/A1:2015 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60601-2-33:2010/A1:2015 has the following relationships with other standards: It is inter standard links to SIST EN IEC 60601-2-33:2024, SIST EN 60601-1:2007/A1:2014, SIST EN 60601-1:2007, SIST EN 60601-2-33:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60601-2-33:2010/A1:2015 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.
SIST EN 60601-2-33:2010/A1:2015 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
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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
...