IEC 80601-2-49:2018

Title
Abstract

IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment.
The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units.
For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient.
This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply.
This document does not apply to implantable parts of multifunction patient monitors.
This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.

Issue Date

2018-03-08

Category

MED

Included in IECEE System

2018-05-08

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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.

No information declared

Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Littleton 01460

United States of America

Pointe Claire

Canada

Toronto

Canada

Dresden

Germany

Fehraltorf

Switzerland

Reichenwalde b. Berlin

Germany

Modiin

Israel

Gimpo-si

Korea, Republic of

Boxborough,

United States of America

Duluth,

United States of America

Lake Forest,

United States of America

Plano,

United States of America

Kista

Sweden

Guangzhou, Guangdong

China

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

TRAPPES

France

Oak Creek

United States of America

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Tampere

Finland

Helsinki

Finland

Puchheim

Germany

Suwanee

United States of America

Madrid

Spain

Shanghai

China

Guangzhou

China

Shenzhen

China

Ljubljana

Slovenia

Dongguan

China

Bangalore – 560 100

India

Tel-Aviv

Israel

Nanshan District

China

Budapest

Hungary

Yokohama,

Japan

Peabody

United States of America

San Diego

United States of America

GORMLEY

Canada

Jiangsu

China

Guangzhou

China

München

Germany

Whitefield

India

Ballerup

Denmark

Neu-Isenburg (Zeppelinheim)

Germany

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

Melville

United States of America

Mounds View

United States of America

Northbrook, IL 60062

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

13372

Fehraltorf

Switzerland

13348

Reichenwalde b. Berlin

Germany

20269

Modiin

Israel

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13641

Paris Cedex 15

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13367

Ljubljana

Slovenia

13349

Budapest

Hungary

13354

Yokohama

Japan

13345

Nürnberg

Germany

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