EN 62570:2015
Current
The latest, up-to-date edition.
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
22-05-2015
FOREWORD
1 Scope
2 Referenced Documents
3 Terminology
4 Significance and Use
5 Requirements for assessment of potential hazards
caused by interactions of an item and the MR Environment
6 Methods of Marking
7 Information Included in MR Marking
8 Keywords
APPENDIX X1 - RATIONALE
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
IEC 62570:2014 applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking. The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons. MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice. IEC 62570 is integrating the unmodified text of ASTM F2503-13. It has been developed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Medical equipment in medical practice, in collaboration with ASTM.
| Committee |
CLC/TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Standards | Relationship |
| IEC 62570:2014 | Identical |
| NF EN 62570 : 2015 | Identical |
| NBN EN 62570 : 2015 | Identical |
| NEN EN IEC 62570 : 2015 | Identical |
| I.S. EN 62570:2015 | Identical |
| PN EN 62570 : 2015 | Identical |
| SN EN 62570:2015 | Identical |
| BS EN 62570:2015 | Identical |
| CEI EN 62570 : 2016 | Identical |
| DIN EN 62570:2016-09 | Identical |
| UNE-EN 62570:2015 | Identical |
| PNE-FprEN 62570 | Identical |
| I.S. 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 |
| BS 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 |
| EN 60601-2-33:2010/A12:2016 | 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+AMD1:2013+AMD2:2015 CSV | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| EN 60601-2-33:2010/A12:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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