Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

Available format(s)

Hardcopy , PDF

Language(s)

English - French

Published date

29-04-2020

Publisher

National Standards Authority of Ireland

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FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility – Requirements and tests
203 Radiation protection in diagnostic X-ray equipment
Annexes
Annex AA (informative) Particular guidance and rationale
Annex BB (normative) Distribution maps of STRAY RADIATION
Annex CC (informative) Mapping between this Edition 2 of IEC 60601-2-43 and Edition 1
Bibliography
Index of defined terms used in this particular standard

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT.

Committee	SC 62B
DocumentType	Standard
ISBN	978-2-8322-4318-3
Pages	154
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO IEC/TR 60788,IEC TR 60788:2004,21 CFR Part 1020
PublisherName	National Standards Authority of Ireland
Status	Current
SupersededBy	I.S. EN IEC 60601-2-43:2023
Supersedes	I.S. EN 60601-2-43:2010

Standards	Relationship
EN 60601-2-43:2010/A2:2020	Identical
IEC 60601-2-43:2010/AMD2:2019	Identical
IEC 60601-2-43:2010/AMD1:2017	Identical

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I.S. EN 60601-2-43:2010/A2:2020

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