AS/NZS 3200.2.34:1996
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Direct blood-pressure monitoring equipment
Specifies medical electrical equipment, including transducers, used for monitoring and recording the internal blood-pressure of patients. This standard is identical to and reproduced from IEC 60601-2-34:1994.
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AS/NZS 3200.2.34:1996 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—DIRECT
PREFACE
CONTENTS
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
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous leakage currents and patient auxiliary currents
20 Dielectric strength
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE 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
45 Pressure vessels and parts subject to pressure
46 Human errors
SECTION EIGHT: ACCURACY OF OPERATION DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 Mains parts, components and layout
Appendix D - Symbols on markings
Annex AA - General guidance and rationale
General
Use with defibrillator
Rationale for defibrillator test voltages
Summary
Specific requirement
Guidance and rationale for particular subclauses:
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AS/NZS 3200.2.34:1996 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—DIRECT
PREFACE
CONTENTS
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
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous leakage currents and patient auxiliary currents
20 Dielectric strength
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE 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
45 Pressure vessels and parts subject to pressure
46 Human errors
SECTION EIGHT: ACCURACY OF OPERATION DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 Mains parts, components and layout
Appendix D - Symbols on markings
Annex AA - General guidance and rationale
General
Use with defibrillator
Rationale for defibrillator test voltages
Summary
Specific requirement
Guidance and rationale for particular subclauses:
AS/NZS 3200.2.34:1996
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.