AS/NZS 3200.2.8:1994

1 - AS/NZS 3200.2.8:1994 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - THERAPEUTIC X-RAY GENERATORS
4 - PREFACE
5 - CONTENTS
8 - SECTION ONE - GENERAL
8 - 1 Scope and object
9 - 2 Terminology and definitions
10 - 3 General requirements
10 - 4 General requirements for tests
10 - 5 Classification
11 - 6 Identification, marking and documents
15 - 7 Power input
15 - SECTION TWO - ENVIRONMENTAL CONDITIONS
15 - 8 Basic safety categories
15 - 9 Removable protective means
15 - 10 Special environmental conditions
15 - 11 Special measures with respect to safety
15 - 12 Single fault conditions
15 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 - 13 General
15 - 14 Requirements related to classification
15 - 15 Limitation of voltage and/or current
16 - 16 Enclosures and protective covers
16 - 17 Insulation and protective impedances
16 - 18 Protective earthing, functional earthing and potential equalization
16 - 19 Continuous leakage currents and patient auxiliary currents
17 - 20 Dielectric strength
18 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
18 - 21 Mechanical strength
18 - 22 Moving parts
18 - 23 Surfaces, corners and edges
18 - 24 Stability and transportability
19 - 25 Expelled parts
19 - 26 Vibration and noise
19 - 27 Pneumatic and hydraulic power
19 - 28 Suspended masses
19 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
19 - 29 X-radiation
27 - 30 Alpha, beta, gamma, neutron radiation and other particle radiation
27 - 31 Microwave radiation
27 - 32 Light radiation (including visible radiation and lasers)
27 - 33 Infra-red radiation
27 - 34 Ultra-violet radiation
27 - 35 Acoustical energy (including ultrasonics)
27 - 36 Electromagnetic compatibility
28 - SECTION SIX-PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
28 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
28 - 42 Excessive temperatures
28 - 43 Fire prevention
28 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
28 - 45 Pressure vessels and parts subject to pressure
28 - 46 Human errors
28 - 47 Electrostatic charges
29 - 48 Biocompatibility
29 - 49 Interruption of the power supply
29 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
35 - 51 Protection against hazardous output
35 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS
35 - 52 Abnormal operation and fault conditions
35 - 53 Environmental tests
36 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
36 - 54 General
36 - 55 Enclosures and covers
36 - 56 Components and general assembly
36 - 57 Mains parts, components and layout
36 - 58 Protective earth terminals
36 - 59 Construction and layout
37 - ANNEX AA2 - ALPHABETICAL INDEX OF TERMS
40 - ANNEX BB - List of standards mentioned in this Particular Standard

Applies to therapeutic X-ray generators that operate within nominal X-ray tube voltages from 10 kV to 400 kV inclusive when connected to alternating current supply mains. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-8:1987.

Addition:This Particular Standard applies to therapeutic X-RAY GENERATORS that operate with NOMINAL X-RAY TUBE VOLTAGES from 10 kV to 400 kV inclusive when connected to alternating current SUPPLY MAINS.

First published as Joint Standard AS/NZS 3200.2.8:1994.