AS/NZS 3200.2.29:2000

1 - AS/NZS 3200.2.29:2000 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-RADIOTHERAPY SIMULATORS (IEC 60601-2-
4 - PREFACE
6 - CONTENTS
8 - INTRODUCTION
9 - SECTION ONE - GENERAL
9 - 1 Scope and object
9 - 1.1 Scope
9 - 1.2 Object
10 - 1.3 Particular Standards
10 - 1.3.101 Relationship to the General Standard.
10 - 1.3.102 Relationship to other standards and documents
11 - 1.5 Collateral Standards
11 - 1.5.101 IEC 60601-1-1
11 - 1.5.102 IEC 60601-1-2
11 - 1.5.103 IEC 60601-1-3
11 - 1.5.104 IEC 60601-1-4
11 - 2 Terminology and definitions
11 - 2.1.101 DELINEATED RADIATION BEAM
11 - 2.1.102 DELINEATED RADIATION FIELD
11 - 2.1.103 DELINEATOR(s)
11 - 2.1.104 RADIOTHERAPY SIMULATOR (hereinafter referred to as SIMULATOR)
12 - 5 Classification
12 - 6 Identification, marking and documents
12 - 6.3 Marking of controls and instruments
12 - 6.3.101 Provision of scales and indications for moving parts
13 - 6.7 Indicator lights and push-buttons
13 - 6.8 Accompanying documents
13 - 6.8.1 General
13 - 6.8.2 Instructions for use
14 - 6.8.3 Technical description
15 - SECTION TWO - ENVIRONMENTAL CONDITIONS
15 - 10 Environmental conditions
15 - 10.2.2 Power supply
15 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 - 16 ENCLOSURES and PROTECTIVE COVERS
15 - 18 Protective earthing, functional earthing and potential equalization
16 - 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
16 - 19.1 General requirements
16 - 19.3 Allowable values
17 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
17 - 22 Moving parts
17 - 22.4 Powered movements (see figures 101, 102 and 103)
17 - 22.4.1 GANTRY, RADIATION HEAD, X-RAY IMAGE RECEPTOR and PATIENT SUPPORT system
18 - 22.4.2 Operation of movements of EQUIPMENT parts from inside the SIMULATOR room
19 - 22.4.3 Operation of movements of EQUIPMENT parts from outside the SIMULATOR room
19 - 22.7
19 - 22.7.101 Motors emergency stop
20 - 27 Pneumatic and hydraulic power
20 - 27.101 Change of pressure
20 - 28 Suspended masses
20 - 28.101 Attachment of ACCESSORIES
20 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
20 - 29 X-RADIATION
20 - 29.1 General requirements
22 - 29.101 Adventitious IONIZING RADIATION
23 - 36 ELECTROMAGNETIC COMPATIBILITY
23 - 36.201 EMISSIONS
23 - 36.201.1 Radio-frequency (RF) emissions
23 - 36.202 IMMUNITY
23 - 36.202.2 Radiated radio-frequency electromagnetic fields
24 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
24 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
24 - 52 Abnormal operation and fault conditions
24 - 52.1 Replacement:
29 - Appendix L - References - Publications mentioned in this standard
30 - Annex AA - Terminology - Index of defined terms
33 - Annex BB - Bibliography
34 - APPENDIX ZZ - SUPPLEMENTARY REQUIREMENTS ADDED TO IEC 60601-2-29 FOR ITS APPLICATION IN AUSTRALIA AND NEW ZEALAND

Specifies requirements for the safe design and manufacture of radiotherapy simulators. A thorough knowledge, or a readily available copy of the parent Standard, AS/NZS 3200.1.0:1998, is necessary to deal with some of the technical issues raised. This Standard has been reproduced from IEC 60601.2.29:1999, but includes a ZZ Appendix of supplementary requirements for Australia and New Zealand.

Addition:This Particular Standard applies to RADIOTHERAPY SIMULATORS:– that use diagnostic X-RAY EQUIPMENT to simulate physically a RADIOTHERAPY RADIATION BEAM, so that the TREATMENT VOLUME to be subjected to IRRADIATION during RADIOTHERAPY can be localized, and the position and size of the RADIOTHERAPY RADIATION FIELD can be confirmed;– intended exclusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general diagnostic examinations;– used within the environmental and electrical supply conditions SPECIFIED in the technical description;– comprising the following parts:• a system for producing an X-RAY BEAM, which simulates the geometry of the RADIOTHERAPY RADIATION BEAM;• a system for producing images of the transmitted X-RAY BEAM, for example, either byRADIOGRAPHY or RADIOSCOPY;• an assembly to control the size and position of the RADIATION BEAM and to delineate the intended treatment area;• a mechanical structure that physically simulates the geometry and movements of the RADIOTHERAPY EQUIPMENT and supports the imaging system;• a PATIENT SUPPORT system.

First published as AS/NZS 3200.2.29:2000.