AS 3200.2.200-1992

1 - AS 3200.2.200-1992 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-OXYGEN CONC
4 - PREFACE
5 - CONTENTS
6 - INTRODUCTION
6 - SECTION ONE-GENERAL
6 - 1 Scope and object
7 - 2 Terminology and definitions
7 - 5 Classification
8 - 6 Identification, marking and documents
10 - 7 Power input
10 - SECTION TWO-ENVIRONMENTAL CONDITIONS
10 - 8 Basic safety categories
10 - 9 Removable protective means
10 - 10 Environmental conditions
10 - 12 Single fault condition
10 - SECTION THREE-PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
11 - SECTION FOUR-PROTECTION AGAINST MECHANICAL HAZARDS
11 - 21 Mechanical strength
11 - 26 Vibration and noise
11 - 27 Pneumatic and hydraulic power
11 - 28 Suspended masses
11 - SECTION FIVE-PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
12 - SECTION SIX -PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
12 - SECTION SEVEN-PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
12 - 42 Excessive temperatures
12 - 43 Fire prevention
13 - SECTION EIGHT-ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
13 - 50 Accuracy of operating data
15 - 51 Protection against hazardous output
15 - SECTION NINE-ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
15 - 52 Abnormal operation and fault conditions
15 - 53 Environmental tests
16 - SECTION TEN-CONSTRUCTIONAL REQUIREMENTS
16 - 56 Components and general assembly
17 - APPENDIX AA - Rationale
19 - APPENDIX BB - TEST APPARATUS
19 - Apparatus
19 - Test assembly
21 - APPENDIX ZZ - AMENDMENTS TO ISO 8359 FOR APPLICATION IN AUSTRALIA
22 - NATIONAL CERTIFICATION SCHEME

Specifies safety requirements for oxygen concentrators which provide oxygen-enriched air for supply to patients by separating nitrogen from ambient air. Does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation, or to those intended for use in the presence of either flammable anaesthetic or cleaning agents. This Standard is to be read in conjunction with AS 3200.1.0-1990, and is technically equivalent to ISO 8359:1988.

ISO 8359 is one of a series of International Standards based on IEC Publication 601-1; in IEC Publication 601-1 (the 'General Standard'), this type of International Standard is referred to as a 'Particular Standard'. As stated in 1.3 of IEC Publication 601-1, the requirements of this International Standard take precedence over those of IEC Publication 601-1.The scope and object given in clause 1 of AS 3200.1 applies except that 1.1 shall be replaced by the following:This Standard specifies safety requirements for OXYGEN CONCENTRATORS, as defined in 2.1.108 (in this Standard). This Standard does not apply to OXYGEN CONCENTRATORS intended to supply gas to several PATIENTs via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents.The scope of this Standard is not restricted to membrane OXYGEN CONCENTRATORS and pressure swing adsorbers (see Introduction) as alternative methods of concentrating oxygen may become available and it is not intended that this Standard should restrict future developments.

First published as AS 3200.2.200-1992.