Table of Contents
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AS/NZS 3200.2.34:1996 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-DIRECT
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PREFACE
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CONTENTS
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SECTION ONE: GENERAL
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1 Scope and object
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1.1 Scope
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1.2 Object
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1.3 Particular Standards
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2 Terminology and definitions
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4 General requirements for tests
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5 Classification
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6 Identification, marking and documents
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SECTION TWO: ENVIRONMENTAL CONDITIONS
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SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
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14 Requirements related to classification
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17 Separation
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19 Continuous leakage currents and patient auxiliary currents
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20 Dielectric strength
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SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
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21 Mechanical strength
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SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
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SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
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SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
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42 Excessive temperatures
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44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
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45 Pressure vessels and parts subject to pressure
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46 Human errors
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SECTION EIGHT: ACCURACY OF OPERATION DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
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51 Protection against hazardous output
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SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
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SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
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56 Components and general assembly
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57 Mains parts, components and layout
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Appendix D - Symbols on markings
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Annex AA - General guidance and rationale
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General
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Use with defibrillator
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Rationale for defibrillator test voltages
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Summary
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Specific requirement
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Guidance and rationale for particular subclauses:
Abstract
Specifies medical electrical equipment, including transducers, used for monitoring and recording the internal blood-pressure of patients. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-34:1994.
Scope
Addition:
This Particular Standard applies to DIRECT BLOOD-PRESSURE MONITORING EQUIPMENT as defined in 2.101, hereinafter referred to as EQUIPMENT.
This Particular Standard does not apply to catheter tubing, catheter needles, Luer locks, taps and taptables, etc.
This Particular Standard also does not apply to indirect blood-pressure monitoring equipment.
General Product Information
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Published
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Document Type
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Standard |
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Status
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Current |
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Publisher
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Standards Australia
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ProductNote
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Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn. |
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Pages
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ISBN
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Committee
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HE-003 |
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Supersedes
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