I.S. EN 60601-1-3:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
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09-01-2021
01-01-2008
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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
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
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| Status |
Superseded
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| 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 |
| SN EN 60601-1-3 : 1994 | Identical |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Identical |
| UNE-EN 60601-1-3:2008 | Identical |
| IEC 60601-2-7:1998 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
| IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| ISO 7004:2002 | Photography Industrial radiographic films Determination of ISO speed, ISO average gradient and ISO gradients G2 and G4 when exposed to X- and gamma-radiation |
| IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| EN 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| IEC 62220-1:2003 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| IEC 60601-2-32:1994 | Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment |
| IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
| EN 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
| IEC 60627:2013 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| ISO 497:1973 | Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers |
| IEC 60601-2-29:2008 | Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
| IEC 60601-2-45:2011+AMD1:2015 CSV | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
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