09/30170496 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
31-05-2011
English
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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Superseded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 |
| 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 |
| ISO 9236-3:1999 | Photography Sensitometry of screen/film systems for medical radiography Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography |
| IEC 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| ISO 12052:2017 | Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management |
| IEC 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| ISO 4090:2001 | Photography Medical radiographic cassettes/screens/films and hard-copy imaging films Dimensions and specifications |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-32:1994 | Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| 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 |
| PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
| 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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