AS/NZS 3200.2.25:1993

1 - AS/NZS 3200.2.25:1993 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-ELECTROC
4 - PREFACE
7 - SECTION ONE - GENERAL
7 - 1 Scope and object
7 - 1.1 Scope
7 - 1.2 Object
7 - 1.3 Particular Standards
8 - 2 Terminology and definitions
9 - 4 General requirements for tests
10 - 5 Classification
10 - 6 Identification, marking and documents
11 - SECTION TWO - ENVIRONMENTAL CONDITIONS
11 - 10 Environmental conditions
11 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
11 - 17 Separation
12 - 19 Continuous leakage currents and patient auxiliary currents
13 - 20 Dielectric strength
13 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
13 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
13 - 34 Ultraviolet radiation
13 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
13 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
14 - 42 Excessive temperatures
14 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
14 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
14 - 51 Protection against hazardous output
17 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
17 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
18 - 57 Mains parts, components and layout
24 - APPENDIX DD - Symbols on marking
25 - APPENDIX ZZ - VARIATIONS TO IEC 601-2-25 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
27 - Annex AA - General guidance and rationale
27 - Use with defibrillator
27 - Rationale for defibrillator test voltages
28 - Summary
28 - Specific requirement
29 - Guidance and rationale for particular subclauses

Specifies the particular safety requirements for electrocardiographs intended for the production of detachable electrocardiographs for diagnostic purposes. It also applies to vector-cardiographs and equipment for stress testing. This Standard is to be read in conjunction with AS 3200.1.0-1990, and is technically equivalent to IEC 601-2-25:1993.

This clause of the General Standard applies except as follows: 1.1* Scope Addition:This Particular International Standard specifies the particular safety requirements for ELECTROCARDIOGRAPHS as defined in 2.102, intended for the production of detachable ELECTROCARDIOGRAMS for diagnostic purposes. It also applies to vector-cardiographs and EQUIPMENT for stress testing.This Particular Standard covers minimum safety requirements.Special requirements concerning use in ambulances, phono-cardiographs, cardiographic monitors, polygraphs, telemetering, special tests (for example, His bundle electrocardiographs), etc. are not covered by this Particular Standard.EQUIPMENT with microelectrodes used directly in the fibres of the heart muscle is also excluded.

First published as AS 3201.3-1971.
Second edition 1974.
Revised and redesignated AS 3203-1981.
Jointly revised and redesignated as Joint Standard AS/NZS 3200.2.25:1993.