AS/NZS 3200.2.201:1996

1 - AS/NZS 3200.2.201:1996 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-DENTO-M
4 - PREFACE
5 - CONTENT
6 - SECTION 1 GENERAL
6 - 1 SCOPE AND OBJECT
6 - 1.1 Scope
6 - 1.2 Object
6 - 1.3 Particular Standards
6 - 1.4 Environmental conditions
6 - 1.101 Application
6 - 1.101.1 Compliance with AS 3100 and AS 3200.1.0 (NZS 6150)
6 - 1.101.2 Special requirements
7 - 2 TERMINOLOGY AND DEFINITIONS
7 - 2.101.1 Coefficient of variation
7 - 2.101.2 Collimators
7 - 2.101.3 Documents
7 - 2.101.4 Exposure
7 - 2.101.5 Filtration
8 - 2.101.6 Protective shielding
8 - 2.101.7 Radiation
8 - 2.101.8 Shall and should
8 - 2.101.9 Shielding
9 - 2.101.10 X-ray equipment
9 - 3 GENERAL REQUIREMENTS
9 - 4 GENERAL REQUIREMENTS FOR TESTS
9 - 5 CLASSIFICATION
9 - 6 IDENTIFICATION, MARKING AND DOCUMENTS
9 - 6.101.1 Documentation, markings and signage on equipment
9 - 6.101.2 Marking
10 - 6.102 Protective devices
10 - 6.103 X-ray tube assemblies
10 - 6.104 Light beam collimator
10 - 7 POWER INPUT
10 - 7.101 Compliance testing
11 - SECTION 2 ENVIRONMENTAL CONDITIONS
11 - SECTION 3 PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
11 - 13.101 HIGH VOLTAGE EQUIPMENT
11 - 13.101.1 High voltage supply
11 - 13.101.2 Termination of high voltage conductors
11 - 13.101.3 High voltage isolation
11 - 13.101.4 Circuit protection
11 - 13.101.5 Undue stress on circuits or insulation
11 - 13.101.6 Supply switch
11 - 13.101.7 Transformers
12 - SECTION 4 PROTECTION AGAINST MECHANICAL HAZARDS
12 - 28.101 SUSPENDED MASSES
12 - 28.101.1 Inspection ports
12 - 28.101.2 Locking devices
12 - 28.101.3 Protection of patient, moving parts
13 - SECTION 5 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
13 - 29.101 INDICATION OF EXPOSURE FACTORS FOR RADIOGRAPHY
13 - 29.101.1 Tube current
13 - 29.101.2 Exposure factors
13 - 29.101.3 Supply indicator
13 - 29.101.4 Beam on indication
13 - 29.101.5 Exposure switch as a remote device
13 - 29.101.6 Remote control
13 - 29.102 AUTOMATIC EXPOSURE FACTORS
14 - 29.103 TIMERS
14 - 29.103.1 The accuracy of the timer
14 - 29.103.2 Single exposure
14 - 29.104 RELIABILITY OF X-RAY OUTPUT PERFORMANCE
14 - 29.104.1 Output performance
15 - 29.104.2 Accuracy of output controls and instruments
15 - 29.105 RADIATION PROTECTION
15 - 29.105.1 Primary limitation of the X-ray beam
15 - 29.105.2 Radiation leakage of X-ray tube assemblies
15 - 29.105.3 Parameters for measuring tube assembly radiation leakage
16 - 29.105.4 Stability of tube head
16 - 29.106 BEAM QUALITY
16 - 29.107 POTENTIAL DIFFERENCE AND FIELD LIMITATIONS OF DENTOMAXILLOFACIAL X-RAY EQUIPMENT
17 - 29.107.1 Extra-oral X-ray sources with intra-oral image receptors
17 - 29.107.2 X-ray equipment used for panoramic tomography
17 - 29.107.3 X-ray equipment for cephalometric radiography
19 - SECTION 6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
19 - SECTION 7 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
19 - SECTION 8 ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
19 - SECTION 9 ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS
20 - SECTION 10 CONSTRUCTIONAL REQUIREMENTS
20 - 59.101 DESIGN AND CONSTRUCTION
20 - 59.101.1 General
20 - 59.101.2 Mechanical requirements
20 - 59.101.3 Hydraulic and pneumatic power
20 - 59.101.4 Stops
20 - 59.101.5 X-ray tube housing
21 - 59.102 MECHANICAL STABILITY (OTHER THAN FIXED EQUIPMENT)
22 - APPENDIX AA - TEST TO BE APPLIED FOR TYPE APPROVAL
23 - APPENDIX LL - AUSTRALIAN / NEW ZEALAND DOCUMENTS REFERENCED IN THIS STANDARD

Specifies safety requirements for X-ray equipment used with intra-oral image receptors, for panoramic tomography and for dedicated cephalometric X-ray equipment. This Standard is to be read in conjunction with AS 3200.1.0-1990.

This specification sets out the particular safety requirements for dento-maxillofacial X-ray equipment.The specification applies to -(a) X-ray equipment intended for use with intra-oral image receptors; (b) X-ray equipment for panoramic tomography; and (c) dedicated cephalometric X-ray equipment.ApplicationCompliance with AS 3100 and AS 3200.1.0 (NZS 6150). This specification shall be read in conjunction with AS 3100 and AS 3200.1.0 (NZS 6150), and the appropriate provisions of these Standards shall apply to the construction of dento-maxillofacial diagnostic X-ray equipment and to the installation and safeguarding of parts which normally carry current.Special requirements of this Standard X-ray equipment covered by this specification shall be deemed to comply with this specification only if it complies with all the requirements of this specification and passes the tests specified herein.Requirements of other Standards Electrical accessories and components incorporated in dento-maxillofacial X-ray equipment which are depended upon for safety shall also comply with the relevant requirements of individual Approval and Test Specifications unless these requirements are varied herein.Where other Australian or Australian/ New Zealand Standards are issued, which deal with specific requirements for the safety of radiological staff, the patient and the public, the more stringent Standards shall apply.Requirements for hazardous locations X-ray equipment suitable for use in areas where flammable medical agents are used including hospitals, medical rooms in industrial premises, dental surgeries, and the like, shall comply with the relevant requirements of AS 1169.Equipment manufactured for any of the purposes detailed in this Standard shall also comply with the regulations and requirements of all relevant state and national regulatory bodies.Practitioners wishing to make use of the equipment specified in this Standard must acquaint themselves with and follow the requirements of their national codes of practice and the requirements of all other relevant regulatory bodies.

First published as part of AS/NZS 3200.2.201:1996.