AS/NZS 3200.2.7:1999

1 - AS/NZS 3200.2.7:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-HIGH VOLTAGE GENERATORS OF DIAGNOSTIC ...
4 - PREFACE
5 - CONTENTS
7 - SECTION 1: GENERAL
7 - 1 Scope and object
7 - 1.1 Scope
7 - 1.2 Object
8 - 1.3 Particular standards
9 - 1.3.101 Related International Standards
9 - 2 Terminology and definitions
10 - 2.101 Qualifying conditions for defined terms
10 - 2.101.1 Operating conditions for nominal X-RAY TUBE VOLTAGE
10 - 2.101.2 PERCENTAGE RIPPLE in CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS
10 - 2.101.3 RADIATION QUANTITY for NOMINAL SHORTEST IRRADIATION TIME
10 - 2.101.4 IRRADIATION TIME
11 - 3 General requirements
11 - 5 Classification
11 - 6 Identification, marking and documents
11 - 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
12 - 6.7 Indicator lights and push-buttons
13 - 6.8 ACCOMPANYING DOCUMENTS
13 - 6.8.2 INSTRUCTIONS FOR USE
14 - 6.8.3 Technical description
14 - 6.8.101 Reference to ACCOMPANYING DOCUMENTS
14 - 6.8.102 Statement of compliance
15 - SECTION 2: ENVIRONMENTAL CONDITIONS
15 - 10 Environmental conditions
15 - 10.2.2 Power supply
17 - SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 - 15 Limitation of voltage and/or energy
17 - 16 ENCLOSURES and PROTECTIVE COVERS
17 - 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
17 - 19.3 Allowable values
18 - 20 Dielectric strength
18 - 20.3 Values of test voltages
19 - 20.4 Tests
20 - SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
20 - SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
20 - 29 X-RADIATION
20 - 29.1 X-RADIATION generated by diagnostic X-RAY GENERATORS containing HIGH-VOLTAGE GENERATORS
20 - 29.1.101 General requirements
20 - 29.1.102 Indication of operational states
21 - 29.1.103 Limitation of RADIATION output
22 - 29.1.104 Safety measures against excessive RADIATION output
23 - 29.1.105 Connection of external INTERLOCKS
23 - 29.1.106 Adequate range of LOADING FACTORS
24 - 36 Electromagnetic compatibility
24 - SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
24 - SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
24 - 42 Excessive temperatures
25 - SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
25 - 50 Accuracy of operating data
25 - 50.1 General
25 - 50.101 Indication of electric and RADIATION output
25 - 50.101.1 General
26 - 50.101.2 Shortened indication
26 - 50.101.3 Indication of varying LOADING FACTORS
26 - 50.102 Reproducibility, linearity and constancy
27 - 50.102.1 Reproducibility of the RADIATION output in INTERMITTENT MODE without AUTOMATIC EXPOSURE CONTROL activated
27 - 50.102.2 Linearity and constancy in INTERMITTENT MODE
30 - 50.103 Accuracy of LOADING FACTORS
30 - 50.103.1 Accuracy of X-RAY TUBE VOLTAGE
30 - 50.103.2 Accuracy of X-RAY TUBE CURRENT
30 - 50.103.3 Accuracy of LOADING TIME
30 - 50.103.4 Accuracy of CURRENT TIME PRODUCT
30 - 50.104 Test conditions
31 - 50.104.1 X-RAY TUBE VOLTAGE
31 - 50.104.2 X-RAY TUBE CURRENT
31 - 50.104.3 IRRADIATION TIME
32 - 50.104.4 CURRENT TIME PRODUCT
32 - 50.105 Conditions for measuring AIR KERMA
32 - 50.105.1 Measuring arrangements
32 - 50.105.2 ATTENUATION and RADIATION QUALITY for measurement of AIR KERMA
33 - 50.105.3 Tests for verifying reproducibility
33 - 50.105.4 Tests for verifying linearity
34 - 51 Protection against hazardous output
34 - SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
34 - SECTION 10: CONSTRUCTIONAL REQUIREMENTS
34 - 56 Components and general assembly
34 - 56.7 Batteries
34 - 56.7.101 Charging mode INTERLOCK
35 - 57 MAINS PARTS, components and layout
35 - 57.10 CREEPAGE DISTANCES and AIR CLEARANCES
38 - APPENDIX ZZ - VARIATIONS TO IEC 60601-2-7 APPLICABLE IN AUSTRALIA AND NEW ZEALAND
40 - Annex AA - Terminology - Index of defined terms
43 - Annex BB - Values of the series R'10 and R'20, ISO 497
44 - Annex CC - Choosing LOADING FACTORS for tests

Specifies particular requirements for the safety of high voltage X-ray generators. It is based on but not equivalent to and reproduced from IEC 60601-2-7:1998 with additional requirements for Australia and New Zealand provided in an appendix. This Standard refers to its Parent Standard, AS/NZS 3200.1.0:1998. An available copy of AS/NZS 3200.1.0 is essential to the meaningful interpretation of this part.

Addition:This Particular Standard applies to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY GENERATORS that operate between 10 kV and 400 kV and in which the electric energy for LOADING an X-RAY TUBE is derived from alternating current SUPPLY MAINS without an essential element of energy storage within the equipment.Note. - An essential element of energy storage is considered not to exist if the energy for LOADING at the LOADING FACTORS defining the NOMINAL ELECTRIC POWER is delivered from the SUPPLY MAINS during LOADING.This Particular Standard applies to:- dental HIGH-VOLTAGE GENERATORS;- sub-assemblies of HIGH-VOLTAGE GENERATORS;- HIGH-VOLTAGE GENERATORS that are integrated with an X-RAY TUBE ASSEMBLY;- HIGH-VOLTAGE GENERATORS of radiotherapy treatment simulators.In this Particular Standard, references to equipment "specified for dental applications" apply only to equipment with NOMINAL X-RAY TUBE VOLTAGES not exceeding 125 kV. For equipment operating above 125 kV the other requirements of this Particular Standard apply without regard to whether dental applications are specified.Where necessary, requirements for X-RAY GENERATORS are given but only where these concern the functioning of the associated HIGH-VOLTAGE GENERATOR.This Particular Standard excludes- equipment for RECONSTRUCTIVE TOMOGRAPHY;- equipment that is battery operated.Rationale. - Requirements to be observed for the equipment excluded from the scope have not been sufficiently investigated. In order not to delay the issue of this Particular Standard such equipment is excluded for the time being.Consideration of those requirements may later allow them to be given as an addendum to this Particular Standard; otherwise they will be dealt with in stand-alone Particular Standards of Part 2 of Publication 601.

First published as AS/NZS 3200.2.7:1994.
Second edition 1999.