BS 5724-2-45(2001) : 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
05-31-2011
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 60601-2-32:1994 | 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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