09/30170496 DC : 0
Superseded
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BS EN 60601-2-45 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
Hardcopy , PDF
English
31-05-2011
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terminology and definitions
201.4 General requirements
201.5 General requirements for testing of
ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and
ME SYSTEMS
201.7 ME EQUIPMENT identification, marking
and documents
201.8 Protection against electrical HAZARDS from
ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of
ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
X-RADIATION HAZARDS
201.11 Protection against excessive temperatures and
other HAZARDS
201.12 Accuracy of controls and instruments and
protection against hazardous outputs
201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
202 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests
202.101 Immunity testing of ESSENTIAL PERFORMANCE
203 Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential performance -
Collateral Standard: Radiation protection in diagnostic
X-ray equipment
203.4 General requirements
203.5 ME EQUIPMENT identification, marking and documents
203.6 X-RADIATION management
203.7 RADIATION QUALITY
203.8 Limitation and indication of the extent of the X-RAY
BEAM and relationship between X-RAY FIELD and
IMAGE RECEPTION AREA
203.10 Attenuation of the X-RAY BEAM between the
PATIENT and the X-RAY IMAGE RECEPTOR
203.11 Protection against RESIDUAL RADIATION
203.13 Protection against STRAY RADIATION
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
BS EN 60601-2-45
| Committee |
CH/62/2
|
| DocumentType |
Draft
|
| Pages |
50
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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