AS/NZS 3200.2.40:1999
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Electromyographs and evoked response equipment
Specifies safety requirements for the design and manufacture of electromyographs and evoked response equipment. It is identical with and has been reproduced from IEC 60501-2-40:1998. 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.
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AS/NZS 3200.2.40:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - ELECTROMYOGRAPHS AND EVOKED RESPONSE.
PREFACE
CONTENTS
INTRODUCTION
SECTION ONE: GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
1.5 Collateral Standards
2 Terminology and definitions
2.1.101 Electromyograph
2.1.102 Evoked response equipment
2.1.103 Electrical stimulator
2.1.104 Pulse duration
2.1.105 Waveform
2.1.106 Auditory stimulator
2.1.107 Visual stimulator
2.1.108 Biopotential input part
5 Classification
6 Identification, marking and documents
6.1 Marking on the outside of equipment or equipment parts
6.7 Indicator lights and push-buttons
6.8 Accompanying documents
6.8.2 Instructions for use
6.8.3 Technical description
7 Power input
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
*14.6 Types B, BF and CF applied parts
20 Dielectric strength
20.2 Requirements for equipment with an applied part
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
36.201 Emissions
36.202 Immunity
36.202.1 Electrostatic discharge
36.202.2 Radiated radiofrequency electromagnetic fields
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
*46 Human errors
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
*50.1 Marking of controls and instruments
*50.2 Accuracy of controls and instruments
51 Protection against hazardous output
*51.101 Supply voltage fluctuations
*51.102 Electrical stimulator output indicator
*51.103 Limitation of electrical stimulator output parameters
51.104 Limitation of visual stimulator output parameters
*51.105 Limitation of auditory stimulator output parameters
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
Annex L - References - Publications mentioned in this Standard
Annex AA - General guidance and rationale
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AS/NZS 3200.2.40:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - ELECTROMYOGRAPHS AND EVOKED RESPONSE.
PREFACE
CONTENTS
INTRODUCTION
SECTION ONE: GENERAL
1 Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
1.5 Collateral Standards
2 Terminology and definitions
2.1.101 Electromyograph
2.1.102 Evoked response equipment
2.1.103 Electrical stimulator
2.1.104 Pulse duration
2.1.105 Waveform
2.1.106 Auditory stimulator
2.1.107 Visual stimulator
2.1.108 Biopotential input part
5 Classification
6 Identification, marking and documents
6.1 Marking on the outside of equipment or equipment parts
6.7 Indicator lights and push-buttons
6.8 Accompanying documents
6.8.2 Instructions for use
6.8.3 Technical description
7 Power input
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
*14.6 Types B, BF and CF applied parts
20 Dielectric strength
20.2 Requirements for equipment with an applied part
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
36.201 Emissions
36.202 Immunity
36.202.1 Electrostatic discharge
36.202.2 Radiated radiofrequency electromagnetic fields
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
*46 Human errors
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
*50.1 Marking of controls and instruments
*50.2 Accuracy of controls and instruments
51 Protection against hazardous output
*51.101 Supply voltage fluctuations
*51.102 Electrical stimulator output indicator
*51.103 Limitation of electrical stimulator output parameters
51.104 Limitation of visual stimulator output parameters
*51.105 Limitation of auditory stimulator output parameters
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
Annex L - References - Publications mentioned in this Standard
Annex AA - General guidance and rationale
AS/NZS 3200.2.40:1999
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.