I.S. EN 60601-1-3:2008
Superseded
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
Hardcopy, PDF
09-01-2021
01-01-2008
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
FOREWORD
INTRODUCTION
INTRODUCTION TO AMENDMENT 1
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification, marking and documents
6 RADIATION management
7 RADIATION QUALITY
8 Limitation of the extent of the X-RAY BEAM and
relationship between X-RAY FIELD and IMAGE
RECEPTION AREA
9 FOCAL SPOT TO SKIN DISTANCE
10 ATTENUATION of the X-RAY BEAM between
the PATIENT and the X-RAY IMAGE RECEPTOR
11 Protection against RESIDUAL RADIATION
12 Protection against LEAKAGE RADIATION
13 Protection against STRAY RADIATION
Annex A (informative) - General guidance and rationale
Annex B (normative) - Values of the series R'10 and R'20,
ISO 497
Annex C (informative) - Mapping between this Edition 2 of
IEC 60601-1-3 and Edition 1
Bibliography
Annex ZA (normative) - Normative references to
international publications with their corresponding
European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
Index of defined terms used in this collateral standard
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