AS/NZS 3200.2.4:1993

1 - AS/NZS 3200.2.4:1993 MEDICAL ELECTRICAL EQUIPMENT-APPROVAL AND TEST SPECIFICATION - PARTICULAR REQUIREMENT FOR SAFETY-CARDIAC...
4 - PREFACE
6 - CONTENTS
8 - SECTION ONE - GENERAL
8 - 1. Scope and object
8 - 2. Terminology and definitions
10 - 3. General requirements
10 - 4. General requirements for tests
10 - 5. Classification
10 - 6. Identification, marking and documents
13 - 7. Power input
13 - SECTION TWO - SAFETY REQUIREMENTS
13 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 - 13. General
13 - 14. Requirements related to classification
14 - 17. Insulation and PROTECTIVE IMPEDANCES
15 - 18. Earthing and potential equalization
15 - 19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
16 - 20. Dielectric strength
19 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
19 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
19 - SECTION SIX - PROTECTION AGAINST THE HAZARDS OF EXPLOSIONS IN MEDICALLY USED ROOMS
19 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES, FIRE AND OTHER HAZARDS, SUCH AS HUMAN ERRORS
19 - 42. Excessive temperatures
19 - 43. Fire prevention
19 - 44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
20 - 45. Pressure vessels and parts subject to pressure
20 - 46. Human errors
21 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST INCORRECT OUTPUT
21 - 50. Accuracy of operating data
22 - 51. Protection against incorrect output
23 - SECTION NINE - FAULT CONDITIONS CAUSING OVERHEATING AND/OR MECHANICAL DAMAGE; ENVIRONMENTAL TESTS
23 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
23 - 56. Components and general assembly
25 - 57. MAINS PARTS, components and layout
25 - SECTION 101 - ADDITIONAL REQUIREMENTS RELATING TO SAFETY
25 - 101. Charging time
25 - 102. INTERNAL ELECTRICAL POWER SOURCE
26 - 103. Endurance
27 - 104. SYNCHRONIZER
27 - 105. Recovery of the CARDIAC MONITOR after defibrillation
28 - 106. Disturbance to the CARDIAC MONITOR from charging or internal discharging
36 - APPENDIX B TESTING DURING MANUFACTURE AND/OR INSTALLATION
37 - APPENDIX AA - RATIONALE
45 - APPENDIX ZZ - AMENDMENTS TO IEC 601-2-4 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND

Specifies requirements for the safety of cardiac defibrillators and cardiac defibrillators-monitors. This Standard is to be read in conjunction with AS 3200.1.0-1990, and is technically equivalent to IEC 601-2-4:1983.

This clause of the General Standard applies except as follows:ScopeAddition:This Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS and CARDIAC DEFIBRILLATOR-MONITORS as defined in Sub-clauses 2.1.101 and 2.1.102, hereinafter referred to as EQUIPMENT, incorporating a capacitive energy storage device.This Standard does not apply to a CARDIAC MONITOR which is not part of aDEFIBRILLATOR-MONITOR.In combined EQUIPMENT in which the ECG monitoring signal cannot be derived via the DEFIBRILLATOR ELECTRODES, this Standard applies to the DEFIBRILLATOR part only.Environmental conditionsItem b) Operation1) EnvironmentAmendment:a) Ambient temperature between 0C and +40C. b) Relative humidity between 30% and 95%, without condensation.

First published in Australia as AS 3201.4-1973.
Revised and redesignated AS 3204-1981.
Jointly revised and redesignated as Joint Standard AS/NZS 3200.2.4:1993.