AS/NZS 3200.2.40:1999

Medical electrical equipment Particular requirements for safety - Electromyographs and evoked response equipment

Standards Australia

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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

Abstract

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.

Scope

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.

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 98343