ISO 80601-2-61 Accredited Testing Labs Worldwide

41 accredited laboratories in 9 countries hold ISO 80601-2-61 in their ISO/IEC 17025 scope. Primary accreditors include American Association for Laboratory Accreditation, Deutsche Akkreditierungsstelle. In the register, ISO 80601-2-61 scope entries most often cover Blood Pressure in Medical equipment, electrical safety and EMC, Medical devices.

Total labs

Countries

Top matrix

Medical equipment, electrical safety and EMC

3 labs

Available in 9 Countries

China

12 labs

Taiwan

2 labs

Netherlands

1 lab

India

1 lab

Finland

1 lab

Canada

1 lab

Japan

1 lab

Top matrices for ISO 80601-2-61

Medical equipment, electrical safety and EMC

3 labs

Medical devices

1 lab

Top analytes for ISO 80601-2-61

Blood Pressure (1)

Sample labs

TUV SUD Certification and Testing (China) Co.,

Wuxi, CN

ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02); IEC 60601-2-68 Edition 1.0 2014-09; IEC 60601-2-68 Edition 2.0 2025-02; ISO 80601-2-69 Second edition 2020-11; ISO 80601-2-70 Second edition 2020-11; ISO 80601-2-74 Fir

Element Materials Technology Seattle - Bothell 120th

Bothell, WA, US

ISO 80601-2-61 (2017), clause 202; ISO 80601-2-61 (2011), clause 202; ISO 9919 Ed. 2.0 (2005), clause 36; ISO 14117 (2012) sections 4 and 5; ISO 14708-1 (2014) clause 27; ISO 14708-3 (2017-04) clause 27; ISO 14708-4 (2008-11-15) claus

Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

ISO 80601-2-61 (2017), clause 202; IEC 80601-2-58:2024; IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30, clause 202; ISO 80601-2-61 (2011), clause 202; IEC 60601-2-62:2013, clause 202; ISO 9919 Ed. 2.0 (2005), clause 36; I

TÜV Technische Überwachung Hessen GmbH EMV-Labor

Kassel, DE

ISO 80601-2-61:2019-09 Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2- 61:2017, korrigierte Fassung 2018-02);

Element Materials Technology Irvine

Irvine, CA, US

ISO 80601-2-61; EN 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; ANSI/AAMI/IEC 80601-2-77:2020; CAN/CSA-C22.2 No. 80601-2-77:19; IEC 60601-2-5:2009; EN 60601-2-5:2015; CSA C22.

TÜV Rheinland LGA Products

Nürnberg, DE

ISO 80601-2-61 : 2019-09 Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2- 61:2017, korrigierte Fassung 2018-02);

Element Materials Technology Boulder

Louisville, CO, US

ISO 80601-2-61 Annex EE; SOP Q001; SOP Q002; SOP Q003; SOP Q004; SOP Q008; SOP I001; SOP Q006; SOP Q014 Heart Rate Monitor Device Validation SOP Q001; SOP Q002; SOP Q003; SOP Q004; SOP Q008; SOP Q006 Consumer Product and Consume

SGS-CSTC Standards Technical Services (Shanghai) Co.,

Xinqiao, Songjiang, Shanghai, CN

ISO 80601-2-61 (Excluding Cl 201.17, 202); EN ISO 80601-2-67 (Excluding Cl 201.17, 202); EN ISO 80601-2-69 (Excluding Cl 201.17, 202)

VDE Prüf- und Zertifizierungsinstitut

Offenbach am Main, DE

ISO 80601-2-61 : 2019-09 Medizinische elektrische Geräte - Teil 2 -61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601 -2- 61:2017, korrigierte Fassung 2018 -

TUV SUD Canada

Gormley, ON, CA

ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018- 02); ISO 80601-2-69 Second edition 2020-11; ISO 80601-2-70 Second edition 2020-11; ISO 80601-2-72 First edition 2015-04-11; ISO 80601-2-72 Second edition 2023-06

CSA Group Bayern

Plattling, DE

ISO 80601-2-61 : 2019-09 Medizinische elektr ische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2-61:2017, korrigierte Fassung 2018-0

Intertek Testing Services NA

Duluth, GA, US

ISO 80601-2-61 (Ed. 1, Ed. 2); ISO 80601-2-67 (Ed. 2); ISO 80601-2-69 (Ed. 2); IEC 62366; IEC 62366-1; IEC 62304 (Ed. 1 + Am 1) Laboratory (excluding Vicat Softening and CRT/High Vacuum) IEC 61010-1, Ed. 2.0; EN 61010-1, Ed. 2.0;

Eurofins Electrical Testing Service (Shenzhen) Co.,

Shenzhen City, Guangdong, CN

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61 Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment ISO/EN ISO 80601-2-69; CSA C22.2 NO. 80601-2-69 Part

Shenzhen Huatongwei International Inspection Co.,

Shenzhen, CN

ISO 80601-2-61 Second Edition 2017-12 (Corrected Version 2018-02) 1-139 ISO 80601-2-69 Second edition 2020-11 1-148 ISO 80601-2-70 Second edition 2020-11 1-151 ISO 80601-2-72 First edition 2015-04-11 1-105 ISO 80601-2-74 First edition 2

DEKRA Testing and Certification

Stuttgart, DE

ISO 80601-2-61 : 2019-09 Medizinische elektr ische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen

MedTech Testing Solution Co.,

New Taipei City, TW

ISO 80601-2-61; EN ISO 80601-2-61; BS EN ISO 80601-2-61; CAN/CSA C22.2 No. 80601-2-61; JIS T 80601-2-61 Nebulizing Systems ISO 27427; EN ISO 27427; BS EN ISO 27427; CAN/CSA ISO 27427; EN 13544-1; BS EN 13544-1 Blood-glucose m

Eurofins Electrical Testing Service (Shanghai) Co.,

Shanghai, CN

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1; EN 60601-1; ANSI/AAMI ES60601-1; CAN/CSA-C22.2 NO.

Shenzhen CTL Testing Technology Co.,

Shenzhen, CN

ISO 80601-2-61; EN ISO 80601-2-61 Medical electrical equipment -- Part 2-56: Particular requirements for the basic safety and essential performance of colinical thermometers for body temperature measurement ISO 80601-2-56; EN ISO

SGS Taiwan

Taoyuan City, TW

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61 Pulse oximeter equipment IEC 80601-2-77; ANSI/AAMI 80601-2-77; CSA C22.2 No. 80601-2-77; EN 80601-2-77 Robotically assisted surgical equipment IEC 80601-2-78; AN

TÜV SÜD Product Service

Frankfurt/Main, DE

ISO 80601-2-61 : 2019-09 Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2-61:2017, korrigierte Fassung 2018-02

Eurofins Product Service

Reichenwalde, DE

ISO 80601-2-61 : 2019-09 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 806

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch

Shenzhen, Guangdong, CN

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61; ISO 80601-2-70; EN ISO 80601-2-70; CAN/CSA-C22.2 No.80601-2-70; ISO 80601-2-72; EN ISO 80601-2-72; CAN/CSA-C22.2 No.80601-2-72; ISO 80601-2-74; EN ISO 80601

DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou Branch

Guangzhou, CN

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61 Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

AA Electro Magnetic Test

Gurgaon, IN

ISO 80601-2-61 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC 60601-2-47 Medical electrical equipment - Part 1-11: Gen

DEKRA Certification

ARNHEM, NL

ISO 80601-2-61 16. Miscellaneous equipment (MISC) Type test of miscellaneous equipment according to the tests in the standard: - Temperature tests - Water and dust ingress tests - Photometric tests - Fire and Flammability tests -

Intertek Testing Services NA

Kentwood, MI, US

ISO 80601-2-61; ISO 80601-2-61 Edition 2.0 2017-12 (Corrected Version 2018-02); IEC 80601-2-77; IEC 80601-2-77 Edition 1.0 2019-07; IEC 80601-2-77 Edition 1.1 2023-11 Consolidated Version; IEC 62304; IEC 62366; IEC 62366-1;

F2 Labs

Middlefield, OH, US

ISO 80601-2-61 Second Edition 2017-12 1 (Corrected version 2018-02) (Section(s) 201.17/202) 1; ISO 80601-2-69 Second Edition 2020-11 (Section(s) 201.17/202) 1; ISO 80601-2-70 Second edition 2020-11; (Section(s) 201.17/202) 1; ISO 80601

steep GmbH EMV-Zentrum

Bonn, DE

ISO 80601-2-61 : 2019-09 Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2-61:2017, korrigierte Fassung 2018

TUV Rheinland of North America

Pleasanton, CA, US

ISO 80601-2-61 3; IEC 80601-2-77 Lighting IEC 60598-1:2003; IEC / EN 60598-1; IEC 60598-1:2003/AMD1:2006; IEC 60598-1:2008; IEC 60598-1:2014; IEC 60598-1:2014/AMD1:2017; IEC / EN 60598-2-1

BUREAU VERITAS CONSUMER PRODUCTS SERVICES

Littleton, MA, US

ISO 80601-2-61 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 80601-2-67 Medical electrical equipment — Part 2-67: Particular requirements for

DEKRA Testing and Certification (Suzhou) Co.,

Suzhou, Jiangsu Province, CN

ISO 80601-2-61; EN ISO 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61

CEcert

Wismar, DE

ISO 80601-2-61:2019-09 Medical electrical equipment – Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximetry equipment (ISO 80601-2-61:2017, corrected version 2018-02); German version EN ISO 8

TÜV Rheinland Korea Ltd. Test Center, Safety of Electrical Appliances and Ergonomics

Republic Of, DE

ISO 80601-2-61:2017 DIN EN 80601-2-61:2019 Medical electrical equipment - Part 2 -61: Particular requirements for basic safety and essential performance of pulse oximeter equipment MED IEC 61010 -2-040:2015 ILNAS EN 61010-2-040:2

Centre Testing International Group Co.,

Shenzhen, Guangdong, CN

ISO 80601-2-61 Second Edition 2017-12 (Corrected Version 2018-02) 1-139

SLG Prüf- und Zertifizierungs

Hartmannsdorf, DE

ISO 80601-2-61 : 2019-09 Medical electrical equipment - Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximetry equipment (ISO 80601-2-61:2017, corrected version 2018-02); German version E

Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

ISO 80601-2-61:20171 (Corrected 2018); EN ISO 80601-2-61:2019; IEC 60601-1, Edition 3.2 Series Test Technology: Test Method(s) 2, 3, 4: National / Regional Variation(s) 2, 3, 4: Medical Electrical Equipment– Part 1: General

SGS Fimko

Helsinki, FI

ISO 80601-2-61 Medical device software - Software life cycle processes IEC 62304; ANSI/AAMI/IEC 62304 Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1; ANSI/AAMI/IEC 62366-1

TUV Rheinland (Shenzhen) Co.,

Shenzhen, CN

ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) 1-139 IEC 80601-2-77 Edition 1.0 2019-07; ANSI/AAMI IEC 80601-2-77:2020 6-438 ISO 80601-2-12 Second edition 2020-02 1-146 ISO 80601-2-69 Second edition 2020-11 1-148 IS

TUV SUD Japan

Tokyo, JP

ISO 80601-2-61:2011 (Excluding Sections 201.12.1.101, 201.15.3.5.101); JIS T 80601-2-61:2014 (Excluding Sections 201.12.1.101, 201.15.3.5.101); ISO 80601-2-61:2017 (Excluding Sections 201.12.1.101, 201.15.3.5.101); CSA-C22.2 No. 8060

TUV SUD America

San Diego, CA, US

ISO 80601-2-61 (clause 202 only); AIM 7351731; AIM 7351731:2017; AIM 7351731:2021; ISO 14708-1 (clause 27 only); ISO 14708-3 (clause 27 only); ISO 14708-7 (clause 27 only); ISO 14117:2019, Sections 4-6; ANSI/USEMCSC C63.27 2021; EN

TUV SUD Certification and Testing (China) Co., Ltd. Shenzhen Branch

Shenzhen, CN

ISO 80601-2-61, Clause 202 of EN ISO 80601-2-61, Clause 202 of ISO 80601-2-69, Clause 202 of EN ISO 80601-2-69, Clause 202 of ISO 80601-2-70, Clause 202 of EN ISO 80601-2-70, Clause 202 of ISO 80601-2-74, Clause 202 of EN ISO 806