AS/NZS 3200.2.27:1996

AS/NZS 3200.2.27:1996 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—ELECTROC

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

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

56 Components and general assembly

57 Mains parts , components and layout

Appendix D - Symbols on markings

Annex AA - General guidance and rationale

Use with defibrillator

Rationale for defibrillator test voltages

Summary

Specific requirement

Guidance and rationale for particular subclauses

APPENDIX ZZ - VARIATIONS TO IEC 601-2-27 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND