AS/NZS 3200.2.25:1993
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Electrocardiographs
Specifies the particular safety requirements for electrocardiographs intended for the production of detachable electrocardiograms for diagnostic purposes. It also applies to vectorcardiographs. It is supplementary to AS 3200.1-1990/NZS6150:1990 Approval and test specification - Medical electrical equipment, Part 1: General requirements for safety, and is technically equivalent to IEC 60601-2-25:1993.
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AS/NZS 3200.2.25:1993 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—ELECTROC
PREFACE
SECTION ONE - GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 Separation
19 Continuous leakage currents and patient auxiliary currents
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
34 Ultraviolet radiation
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
57 Mains parts, components and layout
APPENDIX DD - Symbols on marking
APPENDIX ZZ - VARIATIONS TO IEC 601-2-25 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
Annex AA - General guidance and rationale
Use with defibrillator
Rationale for defibrillator test voltages
Summary
Specific requirement
Guidance and rationale for particular subclauses
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AS/NZS 3200.2.25:1993 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—ELECTROC
PREFACE
SECTION ONE - GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 Separation
19 Continuous leakage currents and patient auxiliary currents
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
34 Ultraviolet radiation
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
57 Mains parts, components and layout
APPENDIX DD - Symbols on marking
APPENDIX ZZ - VARIATIONS TO IEC 601-2-25 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
Annex AA - General guidance and rationale
Use with defibrillator
Rationale for defibrillator test voltages
Summary
Specific requirement
Guidance and rationale for particular subclauses
AS/NZS 3200.2.25:1993
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.