AS/NZS 3200.2.28:1994
Approval and test specification - Medical electrical equipment - Particular requirements for safety - X-ray source assemblies and X-ray tube assemblies for medical diagnosis
Applies to X-ray source assemblies and X-ray tube assemblies for medical diagnosis and to components thereof, specified for use in medical X-ray equipment including equipment for computed tomography incorporating a specified high voltage generator complying with IEC 601-2-7 or IEC 601-2-15. It is supplementary to AS 3200.1-1990/NZS 6150:1990 Approval and test specification - Medical electrical equipment, Part 1: General requirements for safety. This standard is identical to and reproduced from IEC 60601-2-28:1993.
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AS/NZS 3200.2.28:1994 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—X-RAY SO
PREFACE
CONTENTS
SECTION ONE - GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 Enclosures and protective covers
18 Protective earthing, functional earthing and potential equalization
19 Continuous leakage currents and patient currents
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
25 Expelled parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29 X-Radiation
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
45 Pressure vessels and parts subject to pressure
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
Appendix L - References – Publications mentioned in this Standard
Annex AA - Index of defined terms
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AS/NZS 3200.2.28:1994 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—X-RAY SO
PREFACE
CONTENTS
SECTION ONE - GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 Enclosures and protective covers
18 Protective earthing, functional earthing and potential equalization
19 Continuous leakage currents and patient currents
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
25 Expelled parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29 X-Radiation
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
45 Pressure vessels and parts subject to pressure
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
Appendix L - References – Publications mentioned in this Standard
Annex AA - Index of defined terms
AS/NZS 3200.2.28:1994
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.