AS/NZS IEC 60601.2.40:2022
Medical electrical equipment, Part 2.40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Standard identically adopts IEC 60601-2-40:2016 (ED.2.0) which specifies requirements for the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as ME equipment.
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AS/NZS IEC 60601.2.40:2022 Medical electrical equipment Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
English
CONTENTS
FOREWORD
INTRODUCTION
201. 1 Scope, object and related standards
201. 2 Normative references
201. 3 Terms and definitions
201. 4 General requirements
201. 5 General requirements for testing of me equipment
201. 6 Classification of me equipment and me systems
201. 7 Me equipment identification, marking and documents
201. 8 Protection against electrical hazards from me equipment
201. 9 Protection against mechanical hazards of me equipment and me systems
201. 10 Protection against unwanted and excessive radiation hazards
201. 11 Protection against excessive temperatures and other hazards
201. 12 Accuracy of controls and instruments and protection against hazardous outputs
201. 13 Hazardous situations and fault conditions for ME Equipment
201. 14 Programmable electrical medical systems (pems)
201. 15 Construction of me equipment
201. 16 Me systems
201. 17 Electromagnetic compatibility of me equipment and me systems
202 * Electromagnetic disturbances – Requirements and tests
Annexes
Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems
Annex AA (informative) Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
Figures
Figure AA.1 – Suggested test layout for emission and immunity testing
Figure AA.2 – Example of test setup for protectionagainst the effects of hf surgical me equipment
Figure AA.3 – Example of test setup for protectionagainst the effects of hf surgical me equipment
Tables
Table 202.101 – Pass/fail criteria for Table 4 of IEC€60601-1-2:2014
Table 202.102 – Pass/fail criteria for Table 7 of IEC€60601-1-2:2014
Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014
Table 201.C.101 – Marking on the outside of electromyographsand evoked response equipment or its parts
Previous versions
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Related Information
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AS/NZS IEC 60601.2.40:2022 Medical electrical equipment Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
English
CONTENTS
FOREWORD
INTRODUCTION
201. 1 Scope, object and related standards
201. 2 Normative references
201. 3 Terms and definitions
201. 4 General requirements
201. 5 General requirements for testing of me equipment
201. 6 Classification of me equipment and me systems
201. 7 Me equipment identification, marking and documents
201. 8 Protection against electrical hazards from me equipment
201. 9 Protection against mechanical hazards of me equipment and me systems
201. 10 Protection against unwanted and excessive radiation hazards
201. 11 Protection against excessive temperatures and other hazards
201. 12 Accuracy of controls and instruments and protection against hazardous outputs
201. 13 Hazardous situations and fault conditions for ME Equipment
201. 14 Programmable electrical medical systems (pems)
201. 15 Construction of me equipment
201. 16 Me systems
201. 17 Electromagnetic compatibility of me equipment and me systems
202 * Electromagnetic disturbances – Requirements and tests
Annexes
Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems
Annex AA (informative) Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
Figures
Figure AA.1 – Suggested test layout for emission and immunity testing
Figure AA.2 – Example of test setup for protectionagainst the effects of hf surgical me equipment
Figure AA.3 – Example of test setup for protectionagainst the effects of hf surgical me equipment
Tables
Table 202.101 – Pass/fail criteria for Table 4 of IEC€60601-1-2:2014
Table 202.102 – Pass/fail criteria for Table 7 of IEC€60601-1-2:2014
Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014
Table 201.C.101 – Marking on the outside of electromyographsand evoked response equipment or its parts
Previous versions
AS/NZS IEC 60601.2.40:2022
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.