Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

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Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French

Published date

02-26-2014

Publisher

International Electrotechnical Committee

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 (Nonmandatory Information) - RATIONALE

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	TC 62/SC 62B
DevelopmentNote	Stability Date: 2017. (12/2017)
DocumentType	Standard
Pages	34
PublisherName	International Electrotechnical Committee
Status	Current

Standards	Relationship
JIS T 62570:2018	Identical
NF EN 62570 : 2015	Identical
NBN EN 62570 : 2015	Identical
NEN EN IEC 62570 : 2015	Identical
PN EN 62570 : 2015	Identical
ASTM F 2503 : 2013 : REDLINE	Identical
BS EN 62570:2015	Identical
CEI EN 62570 : 2016	Identical
EN 62570:2015	Identical
DIN EN 62570:2016-09	Identical
SN EN 62570:2015	Identical
UNE-EN 62570:2015	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
EN ISO 80601-2-55:2018	Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
ISO 80601-2-55:2018	Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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
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
I.S. EN ISO 80601-2-55:2018	MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018)
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
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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IEC 62570:2014

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Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

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