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BS EN 62570:2015

Current
Current

The latest, up-to-date edition.

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2015

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

Pertains to the practice of marking of items that might be used in the magnetic resonance (MR) environment.

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
CH/62/2
DevelopmentNote
Supersedes 09/30177654 DC. (07/2015)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
IEC 62570:2014 Identical
EN 62570:2015 Identical

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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