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