EN 60601-2-33:2010/A12:2016
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
18-11-2016
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME
SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
Annexes
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements of EU
Directives
Applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.
| Committee |
CLC/TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN 60601-2-33 : 2010 | Identical |
| UNE-EN 60601-2-33:2010/A12:2016 | Identical |
| NF EN 60601-2-33 : 2011 AMD 12 2017 | Identical |
| DIN EN 60601-2-33 : 2017 | Identical |
| I.S. EN 60601-2-33:2010 | Identical |
| NEN EN IEC 60601-2-33 : 2010 AMD 12 2016 | Identical |
| PN EN 60601-2-33 : 2011 AMD 12 2017 | Identical |
| UNE-EN 60601-2-33:2003 | Identical |
| IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV | Identical |
| NBN EN 60601 2-33 : 2010 COR 2016 | Identical |
| SN EN 60601-2-33:2010+A11:2011+A1:2015+A2:2015+AC:2016+A12:2016 | Identical |
| NEN 10601-2-33 : 1995 AMD 11 1997 | Similar to |
| BS EN 60601-2-33:2010+A12:2016 | Identical |
| BS 5724-2.33(1996) : AMD 9724 | Similar to |
| VDE 0750-2-33 : 2017 | Identical |
| EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| I.S. EN 62464-2:2011 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES |
| BS EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| BS EN 62464-2:2011 | Magnetic resonance equipment for medical imaging Classification criteria for pulse sequences |
| I.S. EN 62570:2015 | STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
| CEI EN 62570 : 2016 | STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
| CEI EN 62464-2 : 2012 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES |
| EN 62464-2:2011 | Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences |
| NEMA MS 8:2016 | Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| IEC 60364-7-710:2002 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations |
| CFR 29(PTS1900-1910) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| IEC 62464-1:2007 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 62570:2014 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| NEMA MS 4:2010 | Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging (MRI) Devices |
| EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| IEEE C95.6-2002 | IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz |
| EN ISO 7010 : 2012 AMD 7 2017 | GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016) |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
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