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ASTM F 2052 : 2015 : REDLINE

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Available format(s)

PDF

Superseded date

21-01-2022

Language(s)

English

Published date

15-09-2015

CONTAINED IN VOL. 13.01, 2015 Defines the measurement of the magnetically induced displacement force produced by static magnetic field gradients on medical devices and the comparison of that force to the weight of the medical device.

1.1This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients on medical devices and the comparison of that force to the weight of the medical device.

1.2This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced torque, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system.

1.3This test method is intended for devices that can be suspended from a string. Devices which cannot be suspended from a string are not covered by this test method. The weight of the string from which the device is suspended during the test must be less than 1 % of the weight of the tested device.

1.4This test method shall be carried out in a horizontal bore MR system with a static magnetic filed oriented horizontally and parallel to the MR system bore.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Committee
F 04
DocumentType
Redline
Pages
10
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

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ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
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 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
DIN EN ISO 5840-1 E : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
UNE-EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
PD ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
CEI EN 62570 : 2016 STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT
I.S. EN 45502-2-3:2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
UNE-EN ISO 5366:2017 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
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
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ISO 5840-1:2015 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
ISO 14630:2012 Non-active surgical implants General requirements
DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
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
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 14971:2007 Medical devices Application of risk management to medical devices

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