Table of Contents

SECTION 1 - GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
2 Terminology and definitions
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
SECTION 2 - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
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
22 Moving parts
27 Pneumatic and hydraulic power
SECTION 5 - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
29 X-RADIATION
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
50.101 Accuracy of radiation output
50.102 Accuracy of recorded examination data
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
57 MAINS PARTS, components and layout
57.10 CREEPAGE DISTANCES and AIR CLEARANCES
Annex AA (normative) - Terminology - Index of defined
terms
Annex BB (informative) - Choosing LOADING FACTORS for
tests
Bibliography

Abstract

Adopts IEC 60601-2-44, Ed. 2.1(2002) to specify requirements for X-ray equipment for computed tomography (CT Scanners). Includes safety requirements for the X-ray generator and those where high voltage generators are integrated with an X-ray tube assembly.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
Pages
ISBN
Committee	HE-008
Supersedes	DR 04558 AS/NZS 3200.2.44:2000