AS/NZS 3200.2.7:1999
Approval and test specification - Medical electrical equipment - Particular requirements for safety - High voltage generators of diagnostic X-ray generators
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.
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AS/NZS 3200.2.7:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-HIGH VOLTAGE GENERATORS OF DIAGNOSTIC ...
PREFACE
CONTENTS
SECTION 1: GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular standards
1.3.101 Related International Standards
2 Terminology and definitions
2.101 Qualifying conditions for defined terms
2.101.1 Operating conditions for nominal X-RAY TUBE VOLTAGE
2.101.2 PERCENTAGE RIPPLE in CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS
2.101.3 RADIATION QUANTITY for NOMINAL SHORTEST IRRADIATION TIME
2.101.4 IRRADIATION TIME
3 General requirements
5 Classification
6 Identification, marking and documents
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
6.7 Indicator lights and push-buttons
6.8 ACCOMPANYING DOCUMENTS
6.8.2 INSTRUCTIONS FOR USE
6.8.3 Technical description
6.8.101 Reference to ACCOMPANYING DOCUMENTS
6.8.102 Statement of compliance
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions
10.2.2 Power supply
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy
16 ENCLOSURES and PROTECTIVE COVERS
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
19.3 Allowable values
20 Dielectric strength
20.3 Values of test voltages
20.4 Tests
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29 X-RADIATION
29.1 X-RADIATION generated by diagnostic X-RAY GENERATORS containing HIGH-VOLTAGE GENERATORS
29.1.101 General requirements
29.1.102 Indication of operational states
29.1.103 Limitation of RADIATION output
29.1.104 Safety measures against excessive RADIATION output
29.1.105 Connection of external INTERLOCKS
29.1.106 Adequate range of LOADING FACTORS
36 Electromagnetic compatibility
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
50.1 General
50.101 Indication of electric and RADIATION output
50.101.1 General
50.101.2 Shortened indication
50.101.3 Indication of varying LOADING FACTORS
50.102 Reproducibility, linearity and constancy
50.102.1 Reproducibility of the RADIATION output in INTERMITTENT MODE without AUTOMATIC EXPOSURE CONTROL activated
50.102.2 Linearity and constancy in INTERMITTENT MODE
50.103 Accuracy of LOADING FACTORS
50.103.1 Accuracy of X-RAY TUBE VOLTAGE
50.103.2 Accuracy of X-RAY TUBE CURRENT
50.103.3 Accuracy of LOADING TIME
50.103.4 Accuracy of CURRENT TIME PRODUCT
50.104 Test conditions
50.104.1 X-RAY TUBE VOLTAGE
50.104.2 X-RAY TUBE CURRENT
50.104.3 IRRADIATION TIME
50.104.4 CURRENT TIME PRODUCT
50.105 Conditions for measuring AIR KERMA
50.105.1 Measuring arrangements
50.105.2 ATTENUATION and RADIATION QUALITY for measurement of AIR KERMA
50.105.3 Tests for verifying reproducibility
50.105.4 Tests for verifying linearity
51 Protection against hazardous output
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
56.7 Batteries
56.7.101 Charging mode INTERLOCK
57 MAINS PARTS, components and layout
57.10 CREEPAGE DISTANCES and AIR CLEARANCES
APPENDIX ZZ - VARIATIONS TO IEC 60601-2-7 APPLICABLE IN AUSTRALIA AND NEW ZEALAND
Annex AA - Terminology — Index of defined terms
Annex BB - Values of the series R'10 and R'20, ISO 497
Annex CC - Choosing LOADING FACTORS for tests
Previous versions
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AS/NZS 3200.2.7:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-HIGH VOLTAGE GENERATORS OF DIAGNOSTIC ...
PREFACE
CONTENTS
SECTION 1: GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular standards
1.3.101 Related International Standards
2 Terminology and definitions
2.101 Qualifying conditions for defined terms
2.101.1 Operating conditions for nominal X-RAY TUBE VOLTAGE
2.101.2 PERCENTAGE RIPPLE in CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS
2.101.3 RADIATION QUANTITY for NOMINAL SHORTEST IRRADIATION TIME
2.101.4 IRRADIATION TIME
3 General requirements
5 Classification
6 Identification, marking and documents
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
6.7 Indicator lights and push-buttons
6.8 ACCOMPANYING DOCUMENTS
6.8.2 INSTRUCTIONS FOR USE
6.8.3 Technical description
6.8.101 Reference to ACCOMPANYING DOCUMENTS
6.8.102 Statement of compliance
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions
10.2.2 Power supply
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy
16 ENCLOSURES and PROTECTIVE COVERS
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
19.3 Allowable values
20 Dielectric strength
20.3 Values of test voltages
20.4 Tests
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29 X-RADIATION
29.1 X-RADIATION generated by diagnostic X-RAY GENERATORS containing HIGH-VOLTAGE GENERATORS
29.1.101 General requirements
29.1.102 Indication of operational states
29.1.103 Limitation of RADIATION output
29.1.104 Safety measures against excessive RADIATION output
29.1.105 Connection of external INTERLOCKS
29.1.106 Adequate range of LOADING FACTORS
36 Electromagnetic compatibility
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
50.1 General
50.101 Indication of electric and RADIATION output
50.101.1 General
50.101.2 Shortened indication
50.101.3 Indication of varying LOADING FACTORS
50.102 Reproducibility, linearity and constancy
50.102.1 Reproducibility of the RADIATION output in INTERMITTENT MODE without AUTOMATIC EXPOSURE CONTROL activated
50.102.2 Linearity and constancy in INTERMITTENT MODE
50.103 Accuracy of LOADING FACTORS
50.103.1 Accuracy of X-RAY TUBE VOLTAGE
50.103.2 Accuracy of X-RAY TUBE CURRENT
50.103.3 Accuracy of LOADING TIME
50.103.4 Accuracy of CURRENT TIME PRODUCT
50.104 Test conditions
50.104.1 X-RAY TUBE VOLTAGE
50.104.2 X-RAY TUBE CURRENT
50.104.3 IRRADIATION TIME
50.104.4 CURRENT TIME PRODUCT
50.105 Conditions for measuring AIR KERMA
50.105.1 Measuring arrangements
50.105.2 ATTENUATION and RADIATION QUALITY for measurement of AIR KERMA
50.105.3 Tests for verifying reproducibility
50.105.4 Tests for verifying linearity
51 Protection against hazardous output
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
56.7 Batteries
56.7.101 Charging mode INTERLOCK
57 MAINS PARTS, components and layout
57.10 CREEPAGE DISTANCES and AIR CLEARANCES
APPENDIX ZZ - VARIATIONS TO IEC 60601-2-7 APPLICABLE IN AUSTRALIA AND NEW ZEALAND
Annex AA - Terminology — Index of defined terms
Annex BB - Values of the series R'10 and R'20, ISO 497
Annex CC - Choosing LOADING FACTORS for tests
Previous versions
AS/NZS 3200.2.7:1999
Online Library subscription pricing
The cost of your subscription will depend on which standards you want to access, and how many people in your organisation need to be able to access the Online Library subscription at the same time (concurrent users). During your subscription period, we are also able to make any necessary changes and ensure you are aware of any pricing changes that result. For a quote, contact our Online Library team by emailing onlinelibrary@standards.govt.nz.