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CEI EN 62570 : 2016

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

01-01-2016

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

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

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-241. (08/2017)
DocumentType
Standard
Pages
24
PublisherName
Comitato Elettrotecnico Italiano
Status
Current

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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