MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008)

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Hardcopy , PDF

Language(s)

English

Published date

01-01-2013

Publisher

British Standards Institution

INTRODUCTION
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
Index of defined terms used in this collateral standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

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.

Committee	CH/62/2
DevelopmentNote	Supersedes 90/55349 DC. (11/2005) Supersedes BS 5724-1.3(1995) & 06/30107360 DC. (09/2008) Supersedes 12/30271192 DC. (07/2013) 2008 version along with its corrigendum remains current. (06/2014) 2008 Edition Re-issued in December 2016 & incorporates AMD 11 2016. 2008 + A1 2013 Edition remains active & will be withdrawn on 01/11/2019. (12/2016)
DocumentType	Standard
Pages	56
PublisherName	British Standards Institution
Status	Current
Supersedes	12/30271192 DC : 0 06/30107360 DC : 0 BS 5724-1.3(1995) : 1995

Standards	Relationship
DIN EN 60601-1-3 : 2014	Identical
EN 60601-1-3 : 2008 AMD 11 2016	Identical
I.S. EN 60601-1-3:2008	Identical
SN EN 60601-1-3 : 1994	Identical
IEC 60601-1-3:2008+AMD1:2013 CSV	Identical
UNE-EN 60601-1-3:2008	Identical

BS 7725-3.2(1997) : 1997	EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - CHEMICAL METHODS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
BS EN 61223-3-3:1997	Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiograp hy
BS 7725-3.3(1997) : 1997	EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - CHEMICAL METHODS - IMAGING PERFORMANCE ON X-RAY EQUIPMENT FOR DIGITAL SUBTRACTION ANGIOGRAPHY (DSA)

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 60601-2-28 : 3.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
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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BS EN 60601-1-3 : 2008

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