I.S. EN 60601-1-3:2008
Superseded
View Superseded by
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
01-01-2008
01-09-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
| 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 |
112
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DIN EN 60601-1-3 : 2014 | Identical |
| BS EN 60601-1-3 : 2008 | Identical |
| EN 60601-1-3 : 2008 AMD 11 2016 | Identical |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Identical |
| EN 60601-1-3:2008 | Equivalent |
| IEC 60601-1-3:2008 | Equivalent |
| UNE-EN 60601-1-3:2008 | Identical |
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