AS/NZS 3200.2.201:1996
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Dento-maxillofacial X-ray equipment
Specifies safety requirements for X-ray equipment used with intra-oral image receptors, for panoramic tomography and for dedicated cephalometric X-ray equipment.
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AS/NZS 3200.2.201:1996 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—DENTO-M
PREFACE
CONTENT
SECTION 1 GENERAL
1 SCOPE AND OBJECT
1.1 Scope
1.2 Object
1.3 Particular Standards
1.4 Environmental conditions
1.101 Application
1.101.1 Compliance with AS 3100 and AS 3200.1.0 (NZS 6150)
1.101.2 Special requirements
2 TERMINOLOGY AND DEFINITIONS
2.101.1 Coefficient of variation
2.101.2 Collimators
2.101.3 Documents
2.101.4 Exposure
2.101.5 Filtration
2.101.6 Protective shielding
2.101.7 Radiation
2.101.8 Shall and should
2.101.9 Shielding
2.101.10 X-ray equipment
3 GENERAL REQUIREMENTS
4 GENERAL REQUIREMENTS FOR TESTS
5 CLASSIFICATION
6 IDENTIFICATION, MARKING AND DOCUMENTS
6.101.1 Documentation, markings and signage on equipment
6.101.2 Marking
6.102 Protective devices
6.103 X-ray tube assemblies
6.104 Light beam collimator
7 POWER INPUT
7.101 Compliance testing
SECTION 2 ENVIRONMENTAL CONDITIONS
SECTION 3 PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
13.101 HIGH VOLTAGE EQUIPMENT
13.101.1 High voltage supply
13.101.2 Termination of high voltage conductors
13.101.3 High voltage isolation
13.101.4 Circuit protection
13.101.5 Undue stress on circuits or insulation
13.101.6 Supply switch
13.101.7 Transformers
SECTION 4 PROTECTION AGAINST MECHANICAL HAZARDS
28.101 SUSPENDED MASSES
28.101.1 Inspection ports
28.101.2 Locking devices
28.101.3 Protection of patient, moving parts
SECTION 5 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29.101 INDICATION OF EXPOSURE FACTORS FOR RADIOGRAPHY
29.101.1 Tube current
29.101.2 Exposure factors
29.101.3 Supply indicator
29.101.4 Beam on indication
29.101.5 Exposure switch as a remote device
29.101.6 Remote control
29.102 AUTOMATIC EXPOSURE FACTORS
29.103 TIMERS
29.103.1 The accuracy of the timer
29.103.2 Single exposure
29.104 RELIABILITY OF X-RAY OUTPUT PERFORMANCE
29.104.1 Output performance
29.104.2 Accuracy of output controls and instruments
29.105 RADIATION PROTECTION
29.105.1 Primary limitation of the X-ray beam
29.105.2 Radiation leakage of X-ray tube assemblies
29.105.3 Parameters for measuring tube assembly radiation leakage
29.105.4 Stability of tube head
29.106 BEAM QUALITY
29.107 POTENTIAL DIFFERENCE AND FIELD LIMITATIONS OF DENTOMAXILLOFACIAL X-RAY EQUIPMENT
29.107.1 Extra-oral X-ray sources with intra-oral image receptors
29.107.2 X-ray equipment used for panoramic tomography
29.107.3 X-ray equipment for cephalometric radiography
SECTION 6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
SECTION 8 ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
SECTION 9 ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS
SECTION 10 CONSTRUCTIONAL REQUIREMENTS
59.101 DESIGN AND CONSTRUCTION
59.101.1 General
59.101.2 Mechanical requirements
59.101.3 Hydraulic and pneumatic power
59.101.4 Stops
59.101.5 X-ray tube housing
59.102 MECHANICAL STABILITY (OTHER THAN FIXED EQUIPMENT)
APPENDIX AA - TEST TO BE APPLIED FOR TYPE APPROVAL
APPENDIX LL - AUSTRALIAN / NEW ZEALAND DOCUMENTS REFERENCED IN THIS STANDARD
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AS/NZS 3200.2.201:1996 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—DENTO-M
PREFACE
CONTENT
SECTION 1 GENERAL
1 SCOPE AND OBJECT
1.1 Scope
1.2 Object
1.3 Particular Standards
1.4 Environmental conditions
1.101 Application
1.101.1 Compliance with AS 3100 and AS 3200.1.0 (NZS 6150)
1.101.2 Special requirements
2 TERMINOLOGY AND DEFINITIONS
2.101.1 Coefficient of variation
2.101.2 Collimators
2.101.3 Documents
2.101.4 Exposure
2.101.5 Filtration
2.101.6 Protective shielding
2.101.7 Radiation
2.101.8 Shall and should
2.101.9 Shielding
2.101.10 X-ray equipment
3 GENERAL REQUIREMENTS
4 GENERAL REQUIREMENTS FOR TESTS
5 CLASSIFICATION
6 IDENTIFICATION, MARKING AND DOCUMENTS
6.101.1 Documentation, markings and signage on equipment
6.101.2 Marking
6.102 Protective devices
6.103 X-ray tube assemblies
6.104 Light beam collimator
7 POWER INPUT
7.101 Compliance testing
SECTION 2 ENVIRONMENTAL CONDITIONS
SECTION 3 PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
13.101 HIGH VOLTAGE EQUIPMENT
13.101.1 High voltage supply
13.101.2 Termination of high voltage conductors
13.101.3 High voltage isolation
13.101.4 Circuit protection
13.101.5 Undue stress on circuits or insulation
13.101.6 Supply switch
13.101.7 Transformers
SECTION 4 PROTECTION AGAINST MECHANICAL HAZARDS
28.101 SUSPENDED MASSES
28.101.1 Inspection ports
28.101.2 Locking devices
28.101.3 Protection of patient, moving parts
SECTION 5 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29.101 INDICATION OF EXPOSURE FACTORS FOR RADIOGRAPHY
29.101.1 Tube current
29.101.2 Exposure factors
29.101.3 Supply indicator
29.101.4 Beam on indication
29.101.5 Exposure switch as a remote device
29.101.6 Remote control
29.102 AUTOMATIC EXPOSURE FACTORS
29.103 TIMERS
29.103.1 The accuracy of the timer
29.103.2 Single exposure
29.104 RELIABILITY OF X-RAY OUTPUT PERFORMANCE
29.104.1 Output performance
29.104.2 Accuracy of output controls and instruments
29.105 RADIATION PROTECTION
29.105.1 Primary limitation of the X-ray beam
29.105.2 Radiation leakage of X-ray tube assemblies
29.105.3 Parameters for measuring tube assembly radiation leakage
29.105.4 Stability of tube head
29.106 BEAM QUALITY
29.107 POTENTIAL DIFFERENCE AND FIELD LIMITATIONS OF DENTOMAXILLOFACIAL X-RAY EQUIPMENT
29.107.1 Extra-oral X-ray sources with intra-oral image receptors
29.107.2 X-ray equipment used for panoramic tomography
29.107.3 X-ray equipment for cephalometric radiography
SECTION 6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
SECTION 8 ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
SECTION 9 ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS
SECTION 10 CONSTRUCTIONAL REQUIREMENTS
59.101 DESIGN AND CONSTRUCTION
59.101.1 General
59.101.2 Mechanical requirements
59.101.3 Hydraulic and pneumatic power
59.101.4 Stops
59.101.5 X-ray tube housing
59.102 MECHANICAL STABILITY (OTHER THAN FIXED EQUIPMENT)
APPENDIX AA - TEST TO BE APPLIED FOR TYPE APPROVAL
APPENDIX LL - AUSTRALIAN / NEW ZEALAND DOCUMENTS REFERENCED IN THIS STANDARD
AS/NZS 3200.2.201:1996
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.