| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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17-23
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| Standard | (Included in ASCA) |
IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION
Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
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Scope/AbstractThis part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.
This document does not cover requirements for other equipment used in electroencephalography such as:
- phono-photic stimulators;
- EEG data storage and retrieval;
- ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows.
The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
The phrase "(i.e. electrostatic discharge, electrical fast transients/bursts, surges, electrical transient conduction along supply lines and proximity magnetic fields)" in Paragraph 1 of Clause 202.8.1 General
Clause 202.8.9 IMMUNITY TEST LEVELS |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies: Electrical Safety, Immunity
This standard is recognized in part because:
The phrase "(i.e. electrostatic discharge, electrical fast transients/bursts, surges, electrical transient conduction along supply lines and proximity magnetic fields)" in Paragraph 1 of Clause 202.8.1 is in conflict with another recognized standard, IEC 60601-1-2 Edition 4.1 2020-09 listed below. These electromagnetic phenomena are identified here as non-transient, which is in conflict with the definition of transient phenomena in IEC 60601-1-2 Edition 4.1.
Clause 202.8.9 is in conflict with Clause 8.9, Table 7 of another recognized standard IEC 60601-1-2 Edition 4.1 2020-09. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §882.1400 |
Full-Montage Standard Electroencephalograph
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Class 2
|
GWQ
|
| §882.1400 |
Standard Polysomnograph With Electroencephalograph
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Class 2
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OLV
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| §882.1400 |
Reduced- Montage Standard Electroencephalograph
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Class 2
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OMC
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|
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition Number #19-36)
Sinha, Saurabh R.*; Sullivan, Lucy; Sabau, Dragos; et al.. American Clinical Neurophysiology Society Guideline 1: Minimum Technical Requirements for Performing Clinical Electroencephalography. Journal of Clinical Neurophysiology 33(4):p 303-307, August 2016. | DOI: 10.1097/WNP.0000000000000308 |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
