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SN EN 60601-1-3 : 1994
Withdrawn
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 3. COLLATERAL STANDARD: GENERAL REQUIREMENTS FOR RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
28-02-2011
12-01-2013
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1.203.3 Superseded IEC Standards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
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