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

Current

Current

The latest, up-to-date edition.

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

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


Dates of withdrawal of national standards are available from NSAI.

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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
Supersedes

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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