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BS 5724-2-45(2001) : 2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
Superseded date

05-31-2011

Published date

11-23-2012

SECTION 1: GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
5 Classification
6 Identification, marking and documents
    6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
    6.7 Indicator lights and push-buttons
    6.8 ACCOMPANYING DOCUMENTS
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy
16 ENCLOSURES and PROTECTIVE COVERS
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
    19.3 Allowable values
20 Dielectric strength
    20.3 Values of test voltages
    20.4 Tests
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
24 Stability in normal use
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
29 X-RADIATION
    29.1 X-RADIATION generated by mammographic X-RAY EQUIPMENT
36 Electromagnetic compatibility
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
           FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
           OTHER SAFETY HAZARDS
42 Excessive temperatures
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
           HAZARDOUS OUTPUT
50 Accuracy of operating data
    50.1 General
    50.101 Indication of electric and RADIATION output
    50.102 Reproducibility, linearity and constancy
    50.103 Accuracy of LOADING FACTORS
    50.104 Test conditions
    50.105 Conditions for measuring AIR KERMA
51 Protection against hazardous output
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
           ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
    56.7 Batteries
57 MAINS PARTS, components and layout
    57.10 CREEPAGE DISTANCES and AIR CLEARANCES
Annex AA (normative) Terminology - Index of defined terms
Annex BB (informative) Rationale for allowing full IRRADIATION
         of mammograms
Annex CC (normative) Values of the series R'10 and R'20, ISO 497
Bibliography

Includes safety requirements for X-ray equipment designed for mammography, together with mammographic stereotactic devices.

Committee
CH/71
DocumentType
Standard
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
EN 60601-2-45:2011/A1:2015 Identical

IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
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 60417-2:1998 Graphical symbols for use on equipment - Part 2: Symbol originals
IEC 61223-3-2:2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
ISO 497:1973 Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
IEC 60664-1:2007 Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests

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