AS/NZS 3200.2.17:1994

1 - AS/NZS 3200.2.17:1994 APPROVAL AND TEST SPECIFICATIONS-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY...
4 - PREFACE
5 - CONTENTS
7 - INTRODUCTION
7 - SECTION ONE - GENERAL
7 - 1 Scope and object
9 - 2 Terminology and definitions
9 - 3 General requirements
9 - 4 General requirements for tests
9 - 5 Classification
10 - 6 Identification, marking and documents
13 - 7 Power input
13 - SECTION TWO - ENVIRONMENTAL CONDITIONS
13 - 8 Basic safety categories
14 - 9 Removable protective means
14 - 10 Environmental conditions
14 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
14 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
14 - 29 X-radiation
14 - 30 Alpha, beta, gamma, neutron radiation and other particle radiation
22 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
22 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
22 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
22 - 50 Accuracy of operating data
23 - 51 Protection against hazardous output
24 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
24 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
25 - APPENDIX AA - TERMINOLOGY

Applies to remote-controlled automatically driven electro-medical equipment for gamma-ray therapy of human subjects using afterloading. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-17:1989.

This clause of the General Standard applies except as follows: 1.1 Scope Addition:This Particular Standard specifies requirements for the safety of remote-controlled automatically-driven EQUIPMENT for gamma-ray therapy of human subjects usingAFTERLOADING.This Standard specifies requirements for AFTERLOADING EQUIPMENT- which contains and uses only gamma-ray SEALED RADIOACTIVE SOURCES,- which automatically drives the gamma-ray SEALED RADIOACTIVE SOURCE(S) from a STORAGE CONTAINER to a treatment position inside the SOURCE APPLICATOR(S),- which is designed for connection to a PATIENT, and- with which movements of the RADIOACTIVE SOURCE(S) are carried out automatically by the EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either programmable electronic systems (computer or microprocessors) or non-programmable systems (see also note to Sub-clause 3.2).This Standard is not intended to apply to EQUIPMENT with neutron RADIOACTIVE SOURCES.

First published as Joint Standard AS/NZS 3200.2.17:1994.