• SN EN 60601-1-3 : 1994

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 3. COLLATERAL STANDARD: GENERAL REQUIREMENTS FOR RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT

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    Withdrawn date:  28-02-2011

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    Published date:  12-01-2013

    Publisher:  Swiss Standards

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    Table of Contents - (Show below) - (Hide below)

    Cooperating organizations
    National foreword
    Foreword
    Introduction
    SECTION 1: GENERAL
    1. Scope, object and relationship to other
             standards
    1.201 Scope
    1.202 Object
    1.203 Relationship to other standards
    1.203.1 IEC 601-1
    1.203.2 Particular Standards
    1.203.3 Superseded IEC Standards
    1.203.4 Normative references
    1.203.5 Other related IEC Standards
    2. Terminology and definitions
    2.201 Defined terms
    2.202 Qualifying conditions for defined terms
    2.202.1 Boundary and dimensions of the X-RAY FIELD
    2.202.2 Operating Conditions for NOMINAL X-RAY TUBE
             VOLTAGE
    2.202.3 Effective IMAGE RECEPTION AREA
    2.202.4 The IMAGE RECEPTOR PLANE in X-RAY IMAGE
             INTENSIFIER
             TUBES
    2.202.5 Modes of operation with CONTINUED DISPLAY
    2.203 Composition of reference materials
    2.204 Degrees of requirement and miscellaneous terms
    2.205 RADIATION QUANTITIES and units
    4. General requirements for tests
    4.201 Compliance
    4.201.1 Statement of compliance
    6. Identification, marking and documents
    6.1 Marking on the outside of EQUIPMENT or
             EQUIPMENT
             parts
    6.1.201 Marking requirements in subclauses
    6.1.202 General requirements
    6.8 ACCOMPANYING DOCUMENTS
    6.8.201 Reference in subclauses
    6.8.202 General requirements
    SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
               EXCESSIVE RADIATION
    29. X-RADIATION
    29.201 RADIATION QUALITY
    29.201.1 Limitation of operating voltage range in dental
             applications
    29.201.2 HALF-VALUE LAYERS in X-RAY EQUIPMENT
    29.201.3 FILTRATION in X-RAY TUBE ASSEMBLIES
    29.201.4 FILTRATION in X-RAY SOURCE ASSEMBLIES
    29.201.5 TOTAL FILTRATION in X-RAY EQUIPMENT
    29.201.6 Indication of FILTER properties
    29.201.7 Test for FILTRATION by irremovable materials
    29.201.8 Test for ADDED FILTERS and materials
    29.201.9 Test for HALF-VALUE LAYER
    29.202 Limitation and indication of the extent of the
             X-RAY BEAM
    29.202.1 Enclosure of X-RAY TUBES
    29.202.2 Limiting DIAPHRAGM in X-RAY TUBE ASSEMBLIES
    29.202.3 Confinement of EXTRA-FOCAL RADIATION
    29.202.4 Methods of beam limitation in X-RAY EQUIPMENT
    29.202.5 Indication on the EQUIPMENT
    29.202.6 Indication in the INSTRUCTIONS FOR USE
    29.202.7 Indication by LIGHT FIELD-INDICATOR
    28.202.8 Accuracy of marked and written indications
    29.202.9 Accuracy of indication with a LIGHT
             FIELD-INDICATOR
    29.203 Relationship between X-RAY FIELD and IMAGE
             RECEPTION AREA
    29.203.1 Positioning of the REFERENCE AXIS
    29.203.2 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE
    29.203.3 Interception of the X-RAY BEAM in RADIOSCOPY
    29.203.4 Correspondence between X-RAY FIELD and IMAGE
             RECEPTION AREA
    29.204 LEAKAGE RADIATION
    29.204.1 Mounting of X-RAY SOURCE ASSEMBLIES
    29.204.2 Statement of reference LOADING conditions
    29.204.3 LEAKAGE RADIATION in the LOADING STATE
    29.204.4 LEAKAGE RADIATION during LOADING for voltage
             adjustment
    29.204.5 LEAKAGE RADIATION when not in the LOADING STATE
    29.205 FOCAL SPOT TO SKIN DISTANCE
    29.205 X-RAY EQUIPMENT for RADIOGRAPHY
    29.205.3 Information in the ACCOMPANYING DOCUMENTS
    29.206 ATTENUATION of the X-RAY BEAM
    29.206.1 ATTENUATION by items in the X-RAY BEAM
    29.206.2 Information in the ACCOMPANYING DOCUMENTS
    29.206.3 Test for ATTENUATION EQUIVALENT
    29.207 PRIMARY PROTECTIVE SHIELDING
    29.207.1 Requirements
    29.207.2 Test for ATTENUATION of RESIDUAL RADIATION
    29.207.3 Test for ATTENUATION EQUIVALENT
    29.208 Protection against STRAY RADIATION
    29.208.1 Protection by distance
    29.208.2 Control from a PROTECTED AREA
    29.208.3 Designated SIGNIFICANT ZONES OF OCCUPANCY
    29.208.4 SIGNIFICANT ZONES OF OCCUPANCY with limited
             STRAY RADIATION
    29.208.5 Handgrips and control devices
    29.208.6 Test for STRAY RADIATION
    Annexes
    AAA - Recommendations for the provision of information
          concerning STRAY RADIATION
    BBB - Index of defined terms
    CCC - Normative references to ACCOMPANYING DOCUMENTS,
          INSTRUCTIONS FOR USE and ASSEMBLING INSTRUCTIONS
    ZA (normative) Other international publications quoted
                   in this standard with the references of
                   the relevant European publications
    ZB (informative) Other international publications quoted
                     in this standard with the references of
                     the relevant European publications
    Tables
    201. Subclauses containing requirements for marking
    202. Subclauses requiring statements in ACCOMPANYING
           DOCUMENTS
    203. Voltage restrictions in dental X-RAY EQUIPMENT
    204. HALF-VALUE LAYERS in X-RAY EQUIPMENT
    205. Minimum FOCAL SPOT TO SKIN DISTANCES
    206. ATTENUATION EQUIVALENT of items in the X-RAY BEAM
    207. Parameters for testing ATTENUATION EQUIVALENT
    208a. Application categories
    208b. Requirements for PRIMARY PROTECTIVE SHIELDING
    209. STRAY RADIATION IN SIGNIFICANT ZONES OF OCCUPANCY
    Figures
    201. Zone of EXTRA-FOCAL RADIATION
    202. Discrepancies in visual indication of the X-RAY
           FIELD
    203. Discrepancies in covering the IMAGE RECEPTION
           AREA
    204. Testing for STRAY RADIATION (undertable tube with
           X-RAY BEAM horizontal)
    205. Testing for STRAY RADIATION (undertable tube with
           X-RAY BEAM vertical)
    206. Testing for STRAY RADIATION (overtable tube with
           X-RAY BEAM horizontal)
    207. Testing for STRAY RADIATION (overtable tube with
           X-RAY BEAM vertical)
    208. Example of presentation of data on STRAY
           RADIATION

    Abstract - (Show below) - (Hide below)

    ALSO NUMBERED AS BS 5724: SECTION 1.3: 1995 Establishes general requirements for protection against ionizing radiation in medical diagnostic x-ray equipment. Also gives tables, diagrams, annexes, and terminology and definitions.

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    Document Type Standard
    Publisher Swiss Standards
    Status Withdrawn
    Superseded By
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