SIST EN 60601-2-33:2010/A11:2012
(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
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 točka ali podtočka izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. V nasprotnem primeru tako točka ali podtočka veljata za ustrezno ME OPREMO in ME SISTEME.
General Information
- Status
- Published
- Publication Date
- 22-Nov-2011
- Technical Committee
- IEMO - Electrical equipment in medical practice
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 14-Nov-2011
- Due Date
- 19-Jan-2012
- Completion Date
- 23-Nov-2011
Relations
- Effective Date
- 01-Nov-2024
- Effective Date
- 11-Oct-2011
Overview
EN 60601-2-33:2010/A11:2011 is a CENELEC amendment to the EN 60601-2-33 standard covering medical electrical equipment - particular requirements for the basic safety and essential performance of magnetic resonance (MR) equipment for medical diagnosis. Approved 2011-10-01, this amendment replaces Annex ZZ of the 2010 edition and clarifies the standard’s coverage of essential requirements of the EC Medical Devices Directive (93/42/EEC). The document was prepared by CLC/TC 62 and published in English, French and German.
Key Topics
This amendment and the underlying EN 60601-2-33 standard focus on particular requirements needed to ensure safe, reliable MRI systems. Key technical areas addressed include:
- Basic safety and essential performance criteria for magnetic resonance equipment
- Integration with the EN 60601 family approach to medical electrical equipment safety
- Conformity evidence to relevant EC Directive essential requirements (Annex I of 93/42/EEC)
- Informative guidance on national implementation and patent considerations
Important regulatory detail in Annex ZZ (as replaced by A11):
- The standard claims coverage of most relevant essential requirements of EC Directive 93/42/EEC except for: Essential Requirement 6a; 7.4; 7.5 paragraphs 2 & 3; and 13.6(q). Compliance with the standard therefore supports, but does not by itself guarantee, full conformity to the Directive where those exceptions apply.
Applications
Who uses EN 60601-2-33/A11 and how:
- Manufacturers of MRI scanners and subsystems - to design equipment that meets recognized European safety and performance expectations
- Regulatory affairs and conformity assessment bodies - to prepare technical documentation for CE marking and to assess compliance with the Medical Devices Directive
- Test laboratories and notified bodies - for type testing and certification work on MR equipment
- Clinical engineers and procurement teams - to evaluate safety claims, performance and compliance of MRI systems during selection and acceptance
Practical uses include product design decisions, risk management, test planning, compiling the technical file, and supporting declarations of conformity.
Related standards
- EN 60601 family (general requirements for medical electrical equipment and systems)
- EC Directive 93/42/EEC (Medical Devices Directive) - Annex I essential requirements referenced in Annex ZZ
Keywords: EN 60601-2-33 A11, MRI safety standard, magnetic resonance equipment, medical electrical equipment, CENELEC, Annex ZZ, EC Directive 93/42/EEC, basic safety, essential performance.
Frequently Asked Questions
SIST EN 60601-2-33:2010/A11:2012 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/A11:2012 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/A11:2012 has the following relationships with other standards: It is inter standard links to SIST EN IEC 60601-2-33:2024, 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/A11:2012 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. 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
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DYDUQRVWRSUHPH]D
PDJQHWQRUHVRQDQFR]DPHGLFLQVNRGLDJQRVWLNR
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/A11:2011
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/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
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
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-33: Exigences particulières pour Teil 2-33: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit von Magnetresonanzgeräten
essentielles des appareils à résonance für die medizinische Diagnostik
magnétique utilisés pour le diagnostic
médical
This amendment A11 modifies the European Standard EN 60601-2-33:2010; it was approved by CENELEC on
2011-10-01. 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
...
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