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STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT

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Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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.

DevelopmentNote	For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType	Standard
Pages	46
PublisherName	National Standards Authority of Ireland
Status	Current

Standards	Relationship
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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I.S. EN 62570:2015

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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