ISO/TS 10974:2012
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
30-11-2018
Superseded by
Language(s)
English
Published date
23-04-2012
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ISO/TS 10974:2012 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who might undergo a magnetic resonance scan in 1,5T, cylindrical bore, whole body MR scanners for imaging the hydrogen nucleus.
The tests that are specified in ISO/TS 10974:2012 are type tests intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner.
ISO/TS 10974:2012 contains test methods that are applicable to a broad class of AIMDs for the purpose of evaluating device operation against several hazards.
| DocumentType |
Technical Specification
|
| Pages |
200
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| AAMI ISO TIR 10974 : 2012 | Identical |
| PD ISO/TS 10974:2012 | Identical |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| ANSI/AAMI CI86:2017 | COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING |
| EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| PREN 50527-2-2 : DRAFT 2017 | PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS) |
| BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
| I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| EN 50527-2-2:2018 | Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs) |
| BS EN 62570:2015 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| 13/30233325 DC : 0 | BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| 17/30359914 DC : 0 | BS EN 50527-2-2 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS) |
| I.S. EN 62570:2015 | STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
| I.S. EN 50527-2-2:2018 | PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS) |
| ANSI/AAMI/ISO 14708-3:2017 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| ANSI/AAMI/ISO 14708-1:2014 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| IEC 62570:2014 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
| PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
| CEI EN 62570 : 2016 | STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY 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 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| 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 |
| IEEE C95.3-2002 | IEEE Recommended Practice for Measurements and Computations of Radio Frequency Electromagnetic Fields With Respect to Human Exposure to Such Fields, 100 kHz-300 GHz |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| ISO 5841-3:2013 | Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
| ISO 27186:2010 | Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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