AS/NZS 3200.2.28:1994

1 - AS/NZS 3200.2.28:1994 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-X-RAY SO
4 - PREFACE
6 - CONTENTS
8 - SECTION ONE - GENERAL
8 - 1 Scope and object
8 - 1.1 Scope
8 - 1.2 Object
8 - 1.3 Particular Standards
9 - 2 Terminology and definitions
9 - 4 General requirements for tests
10 - 5 Classification
10 - 6 Identification, marking and documents
15 - 7 Power input
15 - SECTION TWO - ENVIRONMENTAL CONDITIONS
15 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 - 16 Enclosures and protective covers
16 - 18 Protective earthing, functional earthing and potential equalization
16 - 19 Continuous leakage currents and patient currents
16 - 20 Dielectric strength
17 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
17 - 25 Expelled parts
17 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
17 - 29 X-Radiation
17 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
18 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
18 - 42 Excessive temperatures
19 - 45 Pressure vessels and parts subject to pressure
20 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
20 - 50 Accuracy of operating data
20 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
20 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
21 - Appendix L - References – Publications mentioned in this Standard
22 - Annex AA - Index of defined terms

Applies to X-ray source assemblies and X-ray tube assemblies for medical diagno sis and to components thereof, specified for use in medical X-ray equipment including equi pment for computed tomography incorporating a specified high voltage generator complying with AS/NZS 3200.2.7:1994 or AS/NZS 3200.2.15:1994. This Standard is to be read in c onjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-28:1 993.

This Standard applies to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES formedical diagnosis, and to components thereof, specified for use in medical X-RAY EQUIPMENT including equipment for COMPUTED TOMOGRAPHY, that incorporates a specified HIGH-VOLTAGE GENERATOR complying with IEC 601-2-7 or IEC 601-2-15.

First published as a Joint Standard AS/NZS 3200.2.28:1994.