AS/NZS 3200.2.40:1999

1 - AS/NZS 3200.2.40:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - ELECTROMYOGRAPHS AND EVOKED RESPONSE.
4 - PREFACE
6 - CONTENTS
8 - INTRODUCTION
9 - SECTION ONE: GENERAL
9 - 1 Scope and object
9 - 1.1 Scope
9 - 1.2 Object
9 - 1.3 Particular Standards
10 - 1.5 Collateral Standards
10 - 2 Terminology and definitions
10 - 2.1.101 Electromyograph
10 - 2.1.102 Evoked response equipment
10 - 2.1.103 Electrical stimulator
11 - 2.1.104 Pulse duration
11 - 2.1.105 Waveform
11 - 2.1.106 Auditory stimulator
11 - 2.1.107 Visual stimulator
11 - 2.1.108 Biopotential input part
11 - 5 Classification
11 - 6 Identification, marking and documents
11 - 6.1 Marking on the outside of equipment or equipment parts
12 - 6.7 Indicator lights and push-buttons
12 - 6.8 Accompanying documents
12 - 6.8.2 Instructions for use
13 - 6.8.3 Technical description
13 - 7 Power input
13 - SECTION TWO: ENVIRONMENTAL CONDITIONS
14 - SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 - 14 Requirements related to classification
14 - *14.6 Types B, BF and CF applied parts
14 - 20 Dielectric strength
14 - 20.2 Requirements for equipment with an applied part
14 - SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
14 - SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
14 - 36 Electromagnetic compatibility
15 - 36.201 Emissions
15 - 36.202 Immunity
15 - 36.202.1 Electrostatic discharge
15 - 36.202.2 Radiated radiofrequency electromagnetic fields
16 - SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
16 - SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
16 - 42 Excessive temperatures
16 - *46 Human errors
16 - SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
16 - 50 Accuracy of operating data
16 - *50.1 Marking of controls and instruments
17 - *50.2 Accuracy of controls and instruments
17 - 51 Protection against hazardous output
17 - *51.101 Supply voltage fluctuations
17 - *51.102 Electrical stimulator output indicator
17 - *51.103 Limitation of electrical stimulator output parameters
17 - 51.104 Limitation of visual stimulator output parameters
18 - *51.105 Limitation of auditory stimulator output parameters
18 - SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
18 - SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
19 - Annex L - References - Publications mentioned in this Standard
20 - Annex AA - General guidance and rationale

Specifies safety requirements for the design and manufacture of electromyographs and evoked response equipment. It is identical with and has been reproduced from IEC 60601-2-40:1998. This Standard refers extensively to its Parent Standard, AS/NZS 3200.1.0. An available copy of AS/NZS 3200.1.0 is essential to the meaningful interpretation of this Part.

Addition:This Particular Standard applies to ELECTROMYOGRAPHS as defined in 2.1.101 and EVOKED RESPONSE EQUIPMENT as defined in 2.1.102, hereinafter referred to as EQUIPMENT.

First published as AS/NZS 3200.2.40:1999.