ISO 80601-2-61:2017

Title
Abstract

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
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 201.11 and in 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance.
ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use.
ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.
ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use.
ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

Issue Date

2017-12-15

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.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2019-07-05

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Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Littleton 01460

United States of America

Wismar

Germany

94447 Plattling

Germany

Seoul

Korea, Republic of

Pointe Claire

Canada

Toronto

Canada

Arnhem

Netherlands

Guangzhou

China

Dresden

Germany

Campanillas

Spain

Yongin-si

Korea, Republic of

New Taipei City

Chinese Taipei

Fehraltorf

Switzerland

Shanghai

China

Aix en Provence

France

Gyeonggi-do

Korea, Republic of

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

Kista

Sweden

Guangzhou, Guangdong

China

Taipei City

Chinese Taipei

Gyeonggi-do

Korea, Republic of

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Oak Creek

United States of America

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Shenzhen, Guangdong

China

Gyeonggi-do 12735

Korea, Republic of

Tampere

Finland

Helsinki

Finland

Puchheim

Germany

Suwanee

United States of America

Taiwan 248

Chinese Taipei

Madrid

Spain

Shanghai

China

Guangzhou

China

Shenzhen

China

Dongguan

China

Bangalore – 560 100

India

Tel-Aviv

Israel

Nanshan District

China

Budapest

Hungary

Yokohama,

Japan

Seoul, 07298

Korea, Republic of

Berlin

Germany

Nürnberg

Germany

Taoyuan City 333

Chinese Taipei

Peabody

United States of America

San Diego

United States of America

GORMLEY

Canada

Jiangsu

China

Guangzhou

China

Tokyo 160-0023

Japan

Singapore 609937

Singapore

München

Germany

Whitefield

India

Ballerup

Denmark

Uiwang-si

Korea, Republic of

Fremont,

United States of America

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

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

20269

Modiin

Israel

13371

Kista

Sweden

13365

Singapore

Singapore

13424

IL 60005

United States of America

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13359

Gyeonggi-do

Korea, Republic of

13356

Seoul

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

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

13347

Hartmannsdorf

Germany