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09/30170496 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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
Available format(s)

Hardcopy , PDF

Superseded date

31-05-2011

Language(s)

English

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 60601-2-28 : 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 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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