IEC 80601-2-26:2019

Title
Abstract

IEC 80601-2-26:2019 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 electro-convulsive 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.
IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.
The contents of the corrigendum of October 2021 have been included in this copy.

Issue Date

2019-05-20

Category

MED

Included in IECEE System

2019-07-16

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No information declared

DISCLAIMER: National differences

The National differences and Group differences, National Deviations and Special National conditions (SNC), are based solely on information provided to the Secretariat by the IECEE Member Bodies and/or NCBs and other sources. The IEC/IECEE is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. To verify the current status of this type of information, we recommend contacting the Member Body (MB) or National Certification Body (NCB) of the relevant country.

Group Differences are applicable for CENELEC member countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2023-10-27

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Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

94342 Strasskirchen

Germany

Arnhem

Netherlands

Guangzhou

China

Calenzano (FI)

Italy

Reichenwalde b. Berlin

Germany

Modiin

Israel

Milano

Italy

Boxborough,

United States of America

Duluth,

United States of America

Lake Forest,

United States of America

Fridley, MN

United States of America

Kista

Sweden

Guangzhou, Guangdong

China

Kaufbeuren

Germany

Gyeonggi-do

Korea, Republic of

Fontenay-Aux-Roses

France

Oak Creek

United States of America

Carlsbad,

United States of America

Brussels

Belgium

Tampere

Finland

Suwanee

United States of America

Taiwan 248

Chinese Taipei

Madrid

Spain

Shanghai

China

Guangzhou

China

Shenzhen

China

Dongguan

China

Tel-Aviv

Israel

Budapest

Hungary

Peabody

United States of America

San Diego

United States of America

GORMLEY

Canada

Guangzhou 510656

China

Singapore 609937

Singapore

München

Germany

Ballerup

Denmark

Uiwang-si

Korea, Republic of

Mounds View

United States of America

Huangpu District, Guangzhou

China

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

13348

Reichenwalde b. Berlin

Germany

20269

Modiin

Israel

13351

Milano

Italy

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13749

NL - 7327 AC Apeldoorn

Netherlands

13359

Gyeonggi-do

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13349

Budapest

Hungary

13427

Singapore 609937

Singapore

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

13344

Offenbach / Main

Germany

Id

Name

City

Country

13607

Baltimore,

United States of America

13347

Hartmannsdorf

Germany