IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
08-04-2022
Superseded by
Language(s)
English - French
Published date
06-18-2015
Publisher
US$1,030.00
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IEC 60601-2-33:2010+A1:2013+A2:2015 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. It has also been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate. The contents of the corrigendum of March 2012 and February 2016 have been included in this copy. This consolidated version consists of the third edition (2010), its amendment 1 (2013) and its amendment 2 (2015). Therefore, no need to order amendments in addition to this publication.
| Committee |
TC 62/SC 62B
|
| DevelopmentNote |
Stability Date: 2017. (06/2015)
|
| DocumentType |
Standard
|
| Pages |
541
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| GOST IEC 60601-2-33 : 2011 | Identical |
| NBN EN 60601 2-33 : 2010 COR 2016 | Identical |
| NEN EN IEC 60601-2-33 : 2010 AMD 12 2016 | Identical |
| PN EN 60601-2-33 : 2011 AMD 12 2017 | Identical |
| DIN EN 60601-2-33 : 2017 | Identical |
| IS 13450 : Part 2 : Sec 33 : 2018 | Identical |
| BS EN 60601-2-33 : 2010 | Identical |
| EN 60601-2-33:2010/A12:2016 | Identical |
| CSA C22.2 No. 60601.2.33B : 2017 | Identical |
| NEN 10601-2-33 : 1995 AMD 11 1997 | Identical |
| CSA C22.2 No. 601.2.33 : 0 | Identical |
| UNE-EN 60601-2-33:2003 | Identical |
| BS 5724-2.33(1996) : AMD 9724 | Identical |
| GOST R IEC 60601-2-33 : 2013 | Identical |
| VDE 0750-2-33 : 2017 | Identical |
| CEI EN 62464-1 : 2007 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS |
| 09/30177654 DC : 0 | BS EN 62570 - MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - INSTRUCTIONS FOR MARKING ITEMS WITHIN THE CONTROLLED ACCESS AREA |
| I.S. EN 62570:2015 | STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
| AAMI ISO TIR 10974 : 2012 | ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE |
| NF EN 62464-2 : 2011 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES |
| BS EN ISO 14630:2012 | Non-active surgical implants. General requirements |
| EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| ASTM F 2978 : 2013 | Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging |
| I.S. EN 62464-2:2011 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES |
| BS EN 62464-1:2007 | Magnetic resonance equipment for medical imaging Determination of essential image quality parameters |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| I.S. EN ISO 14630:2012 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| NEMA MS 4:2010 | Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging (MRI) Devices |
| NEMA PS3.3 : 2017A | DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 3: INFORMATION OBJECT DEFINITIONS |
| NEMA MS 10:2010 | Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging (MRI) |
| PD IEC/TR 60601-4-1:2017 | Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| BS EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| UNI EN ISO 14630 : 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| BS EN 62464-2:2011 | Magnetic resonance equipment for medical imaging Classification criteria for pulse sequences |
| I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
| ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| IEC 62464-1:2007 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| IEC 62464-2:2010 | Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| IEC 62570:2014 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| UNE-EN ISO 14630:2013 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| PD ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
| 09/30212729 DC : 0 | BS EN 62464-2 - MEDICAL ELECTRICAL EQUIPMENT - MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - CLASSIFICATION CRITERIA FOR PULSE SEQUENCES |
| UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
| 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 |
| I.S. EN 62464-1:2007 | MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| EN 62464-1:2007 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| 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 |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| 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 |
| 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 |
| 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 |
| IEEE C95.6-2002 | IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz |
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