IEC 60601-2-40:2024 PDF

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

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IEC 60601-2-40:2024

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 94
Дата публикации:: 20 декабря 2024 г.
Издание:: IEC IS 60601 edition 3 version 1
ICS:: 11.040.20

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Срок поставки:16 раб. дн. (перевод)

Цена:1 410 €

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IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. The following ME EQUIPMENT are excluded: - ME EQUIPMENT intended for therapeutic application; - ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10). IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) added requirements for constant voltage stimulators; b) clarified requirements for VISUAL STIMULATORS.

Технические детали

Технический комитет: SC 62D - Particular medical equipment, software, and systems
SKU: IEC 60601-2-40:2024

Abstract

Overview

IEC 60601-2-40:2024 is the third edition of the IEC particular standard for the basic safety and essential performance of electromyographs and evoked response equipment (ME EQUIPMENT). It amends and supplements the general standard IEC 60601‑1 and addresses device‑specific hazards, tests and documentation needed to demonstrate safe operation in clinical use. This 2024 edition cancels and replaces the 2016 edition and introduces technical revisions including requirements for constant voltage stimulators and clarified requirements for visual stimulators.

Key topics and requirements

The standard focuses on device safety, performance and verification. Major technical topics include:

Scope and exclusions - applies to electromyographs and evoked response equipment; excludes therapeutic devices and transcutaneous nerve/muscle stimulators covered by IEC 60601‑2‑10.
Basic safety & essential performance - device‑specific requirements that take precedence over IEC 60601‑1 where they differ.
Risk control and hazardous conditions - identification and mitigation of electrical, mechanical, thermal and radiation hazards.
Stimulation requirements - new/updated rules for constant voltage stimulators and stimulation safety.
Visual stimulators - clarified performance and safety requirements for devices delivering visual stimuli for evoked responses.
Electromagnetic compatibility (EMC) - emission and immunity tests aligned with IEC 60601‑1‑2 requirements; pass/fail criteria and test setups are included.
Marking, labeling and documentation - device identification, instructions for use and labelling guidance (Annex C).
Programmable electrical medical systems (PEMS) - requirements for software‑controlled functionality and verification testing.
Test methods and annexes - prescriptive test clauses and informative guidance/rationale (Annex AA).

Practical applications

IEC 60601‑2‑40 is used to:

Guide product design and risk management for electromyographs and evoked response systems.
Define lab test plans for safety, performance and EMC verification.
Support technical files and regulatory submissions for market clearance and conformity assessment.
Inform clinical engineering, procurement and maintenance procedures to ensure safe clinical use.

Who uses this standard

Medical device manufacturers and design engineers
Test laboratories and conformity assessment bodies
Regulatory affairs and compliance teams
Clinical engineers and hospital procurement professionals
Standards writers and quality managers in medtech firms

Related standards

IEC 60601‑1 - General requirements for basic safety and essential performance
IEC 60601‑1‑2 - Electromagnetic compatibility requirements
IEC 60601‑2‑10 - Particular requirements for transcutaneous electrical nerve and muscle stimulators

Keywords: IEC 60601‑2‑40, electromyographs, evoked response equipment, medical electrical equipment, basic safety, essential performance, constant voltage stimulators, visual stimulators, EMC, medical device standards.

Overview

Key topics and requirements

The standard focuses on device safety, performance and verification. Major technical topics include:

Scope and exclusions - applies to electromyographs and evoked response equipment; excludes therapeutic devices and transcutaneous nerve/muscle stimulators covered by IEC 60601‑2‑10.
Basic safety & essential performance - device‑specific requirements that take precedence over IEC 60601‑1 where they differ.
Risk control and hazardous conditions - identification and mitigation of electrical, mechanical, thermal and radiation hazards.
Stimulation requirements - new/updated rules for constant voltage stimulators and stimulation safety.
Visual stimulators - clarified performance and safety requirements for devices delivering visual stimuli for evoked responses.
Electromagnetic compatibility (EMC) - emission and immunity tests aligned with IEC 60601‑1‑2 requirements; pass/fail criteria and test setups are included.
Marking, labeling and documentation - device identification, instructions for use and labelling guidance (Annex C).
Programmable electrical medical systems (PEMS) - requirements for software‑controlled functionality and verification testing.
Test methods and annexes - prescriptive test clauses and informative guidance/rationale (Annex AA).

Practical applications

IEC 60601‑2‑40 is used to:

Guide product design and risk management for electromyographs and evoked response systems.
Define lab test plans for safety, performance and EMC verification.
Support technical files and regulatory submissions for market clearance and conformity assessment.
Inform clinical engineering, procurement and maintenance procedures to ensure safe clinical use.

Who uses this standard

Medical device manufacturers and design engineers
Test laboratories and conformity assessment bodies
Regulatory affairs and compliance teams
Clinical engineers and hospital procurement professionals
Standards writers and quality managers in medtech firms

Related standards

IEC 60601‑1 - General requirements for basic safety and essential performance
IEC 60601‑1‑2 - Electromagnetic compatibility requirements
IEC 60601‑2‑10 - Particular requirements for transcutaneous electrical nerve and muscle stimulators

IEC 60601-2-40:2024 PDF

Технические детали

Abstract

Overview

Key topics and requirements

Practical applications

Who uses this standard

Related standards

Похожие стандарты

Abstract

Overview

Key topics and requirements

Practical applications

Who uses this standard

Related standards

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