ISO 80601-2-55:2018

Title
Abstract

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.
ISO 80601-2-55:2018 specifies requirements for
- anaesthetic gas monitoring,
- carbon dioxide monitoring, and
- oxygen monitoring.
NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.
ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents.
If a clause or subclause is specifically intended to be applicable to me equipment only or to me systems only, the title and 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 relevant.
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 except in IEC 60601‑1:2005+Amd 1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601‑1:2005+Amd 1:2012, 4.2.

Issue Date

2018-02-12

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

Wismar

Germany

94342 Strasskirchen

Germany

Toronto

Canada

Irvine

United States of America

Guangzhou

China

Fehraltorf

Switzerland

Modiin

Israel

Boxborough,

United States of America

Lake Forest,

United States of America

Kista

Sweden

Guangzhou, Guangdong

China

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Oak Creek

United States of America

Carlsbad,

United States of America

Tampere

Finland

Puchheim

Germany

Shanghai

China

Guangzhou

China

Shenzhen

China

Tel-Aviv

Israel

Nanshan District

China

Nürnberg

Germany

Peabody

United States of America

San Diego

United States of America

Jiangsu

China

Guangzhou

China

Singapore 609937

Singapore

München

Germany

Ballerup

Denmark

Uiwang-si

Korea, Republic of

Melville

United States of America

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

13372

Fehraltorf

Switzerland

20269

Modiin

Israel

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

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

13422

Milton Keynes

United Kingdom

13607

Baltimore,

United States of America