Table of Contents

1 -  AS/NZS 3200.2.34:1996 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-DIRECT
4 -  PREFACE
5 -  CONTENTS
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
9 -  5 Classification
9 -  6 Identification, marking and documents
10 -  SECTION TWO: ENVIRONMENTAL CONDITIONS
10 -  SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
11 -  14 Requirements related to classification
11 -  17 Separation
12 -  19 Continuous leakage currents and patient auxiliary currents
13 -  20 Dielectric strength
13 -  SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
13 -  21 Mechanical strength
13 -  SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
14 -  SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
14 -  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
15 -  45 Pressure vessels and parts subject to pressure
16 -  46 Human errors
16 -  SECTION EIGHT: ACCURACY OF OPERATION DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
16 -  51 Protection against hazardous output
17 -  SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
17 -  SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
17 -  56 Components and general assembly
17 -  57 Mains parts, components and layout
23 -  Appendix D - Symbols on markings
24 -  Annex AA - General guidance and rationale
24 -  General
25 -  Use with defibrillator
25 -  Rationale for defibrillator test voltages
26 -  Summary
26 -  Specific requirement
27 -  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

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	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.
Pages
ISBN
Committee	HE-003
Supersedes	DR 95314