IEC 80601 Accredited Testing Labs Worldwide

61 accredited laboratories in 12 countries hold IEC 80601 in their ISO/IEC 17025 scope. Primary accreditors include American Association for Laboratory Accreditation, Deutsche Akkreditierungsstelle. In the register, IEC 80601 scope entries most often cover Body Temperature, Lithium-Ion in Medical equipment, electrical safety and EMC.

Total labs

Countries

Top matrix

Medical equipment, electrical safety and EMC

4 labs

Available in 12 Countries

Germany

19 labs

China

17 labs

Japan

3 labs

Canada

2 labs

Italy

2 labs

Taiwan

2 labs

Finland

1 lab

South Korea

1 lab

India

1 lab

Cyprus

1 lab

Top matrices for IEC 80601

Medical equipment, electrical safety and EMC

4 labs

Top analytes for IEC 80601

Body Temperature (1)
Lithium-Ion (1)

Sample labs

SGS-CSTC Standard Technical Services Co., Ltd. Wuhan Branch

Wuhan, CN

IEC 80601-2-60; IEC 60601-2-63 2; IEC 60601-2-65 2; EN 60601-1; EN 60601-1-3 2;

Element Materials Technology - Malvern

Malvern, GB

IEC 80601-2-49:2018 Ed.1.0 (Only Section 202.8.102); IEC 61000-4-9 AEI Issued:03/01/2001 Ed:1; AIM Standard 7351731 Rev. 3.00 2021-06-04 EMC – Commercial Unintentional Radiated & Conducted Emissions CISPR 11:2015 +A1:2016 & A2:201

UL International Germany

Neu-Isenburg, DE

IEC 80601-2-49 : 2020-10 Medizinische elektr ische Geräte - Teil 2-49: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von multifunktionalen Patientenüberwachungsgeräten (IEC 80601-2-49:2018);

TUV SUD Certification and Testing (China) Co.,

Wuxi, CN

IEC 80601-2-60 Edition 2.0 2019-06; 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

TUV SUD Japan Ltd. Yonezawa Testing Center (EMC Lab)

Yamagata, JP

IEC 80601-2-30 (clause 202 only); IEC 60601-2-37; EN 60601-2-37; JIS T 0601-2-37; IEC 60601-2-37:2007 + AMD1:2015 (clause 202 only); IEC 60601-2-39; EN IEC 60601-2-39; JIS T 0601-2-39 (clause 202 only); IEC 60601-2-47; IEC 60601-2-47

TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch

China, DE

IEC 80601-2-60; IEC 80601-2-60 Edition 2.0 2019-06; CSA C22.2 No. 80601-2-60; EN IEC 80601-2-60

QPS Evaluation Services

Toronto, ON, CA

IEC 80601-2-69; UL 187; UL 60601-1 (excluding Clauses 36, 37, 40, 41, and 44.7) Miscellaneous Electrical Equipment CAN/CSA B149.3; CAN/CSA-C22.2 No. 102; CAN/CSA-C22.2 No. 103; CAN/CSA-C22.2 No. 126; CAN/CSA-C22.2 No. 149; CA

Intertek Japan K.K.

Tokyo, JP

IEC 80601-2-60 Edition 2.0 2019-06; AAMI/CSA 60601-1 ED 3.2; CAN/CSA-C22.2 No. 60601-1:14; JIS T 0601-1 OFF, Office (excluding Ionizing Measurement, Laser Testing) IEC 60950-1 ITAV, IT and AV equipment (excluding Ionizing Measu

Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

IEC 80601-2-49 (2018), clause 202; IEC 60601-2-50, Ed. 2.1 (2016-04); IEC 60601-2-50:2021; ISO 80601-2-55 (2018), clause 202; ISO 80601-2-56, clause 202; ISO 80601-2-61 (2017), clause 202; IEC 80601-2-58:2024; IEC 80601-2-30; EN 806

PRO EMV Labor Strausberg

Strausberg, DE

IEC 80601-2-49 : 2020-10 Medizinische elektrische Geräte - Teil 2-49: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von multifunktionalen Patientenüberwachungsgeräten (IEC 80601-2-49:2018);

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

Guangzhou, Guangdong, CN

IEC 80601-2-60; EN IEC 80601-2-60; CSA C22.2 No. 80601-2-60

TÜV Technische Überwachung Hessen GmbH EMV-Labor

Kassel, DE

IEC 80601-2-49:2020-10 Medizinische elektrische Geräte - Teil 2-49: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von multifunktionalen Patientenüberwachungsgeräten (IEC 80601-2-49:2018); De

Element Materials Technology Irvine

Irvine, CA, US

IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30 (excluding 201.15.3.5); IEC 80601-2-60; EN 80601-2-60; CAN/CSA-C22.2 No. 80601-2-60, (excluding 201.10.4); ISO 80601-2-61; EN 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61; IEC 80

TÜV Rheinland LGA Products

Nürnberg, DE

IEC 80601-2-30:2009 + Cor. :2010); Deutsche Fassung EN 80601-2-30:2010 DIN EN ISO 80601-2-55 : 2019-03 Medizinische elektrische Geräte - Teil 2-55: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale

TÜV Rheinland Japan Ltd. Yokohama Laboratories Global Technology Assessment Center

Japan, DE

IEC 80601 -2-49:2018 Historical EN 60601-2-49 :2019 Historical DIN EN IEC 80601-2-49 Historical VDE 0750-2-49:2020-10 Historical Medical electrical equipment - Part 2 -49: ParDcular requirements for the basic safety and essenDa

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

Xinqiao, Songjiang, Shanghai, CN

IEC 80601-2-26 (Excluding Cl 201.17, 202); EN IEC 80601-2-30 (Excluding Cl 201.17, 202); EN 80601-2-30 (Excluding Cl 201.17, 202); EN 80601-2-35 (Excluding Cl 201.17, 202); EN IEC 80601-2-49 (Excluding Cl 201.11.6.5, 201.17, 202); EN I

VDE Prüf- und Zertifizierungsinstitut

Offenbach am Main, DE

IEC 80601-2-26:2022-04 Medizinische elektrische Geräte - Teil 2 -26: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen (IEC 80601 -2- 26:2019); Deutsche Fassung EN IEC

TUV SUD Canada

Gormley, ON, CA

IEC 80601-2-30: Edition 2.0 2018-03; ANSI AAMI IEC 80601-2-30:2018; IEC 60601-2-33 Ed. 3.2 b:2015; IEC 60601-2-33 Edition 4.0 2022-08; IEC 60601-2-34 Edition 3.0 2011-05; IEC 60601-2-35 Edition 2.0 2020-09; IEC 60601-2-37 Edition 2.1

CSA Group Bayern

Plattling, DE

IEC 80601-2- 58:2014 + A1:2016); Deutsche Fassung EN 80601-2-58:2015 + A1:2019; VDE 0750-2-58:2020-06 DIN EN 80601-2-58 : 2015-11 ⊗ - Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit einschließlich

Intertek Testing Services NA

Duluth, GA, US

IEC 80601-2-26 (Ed. 1 + Am 1); IEC 80601-2-30 (Ed. 1.1, Ed. 2.0); ANSI/AAMI/IEC 80601-2-30:2018; IEC 80601-2-35 (Ed. 1 + Am 1) (excluding cl 201.8.8.4.101); IEC 80601-2-49 (Ed. 1); IEC 80601-2-60 (Ed. 1, Ed. 2); ISO 80601-2-61 (Ed. 1,

Eurofins Electrical Testing Service (Shenzhen) Co.,

Shenzhen City, Guangdong, CN

IEC 80601-2-30; CSA C22.2 NO.80601-2-30:19 Medical electrical equipment - Part 2- 47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC/EN 60601-2-47; ANSI AAMI IE

Shenzhen Huatongwei International Inspection Co.,

Shenzhen, CN

IEC 80601-2-30 Edition 2.0 2018-03 3-123 IEC 80601-2-60 Edition 2.0 2019-06 4-262 ISO 80601-2-56 Second Edition 2017-03 6-421 ISO 80601-2-61 Second Edition 2017-12 (Corrected Version 2018-02) 1-139 ISO 80601-2-69 Second edition 2020-11

MedTech Testing Solution Co.,

New Taipei City, TW

IEC 80601-2-30; EN IEC 80601-2-30; BS EN IEC 80601-2-30; CAN/CSA C22.2 No. 80601-2-30 Multifunction patient monitors IEC 80601-2-49; EN IEC 80601-2-49; BS EN IEC 80601-2-49; CAN/CSA C22.2 No. 80601-2-49 Dental equipment IEC 8060

UL LLC

Novi, MI, US

IEC 80601-2-77 Edition 1.0 2019-07 (clauses 201.17, 202 only) 6-438 IEC/TR 60601-4-2 Edition 1.0 2016-05 19-19 IEC TS 60601-4-2 Edition 1.0 2024-03 19-50

Eurofins Electrical Testing Service (Shanghai) Co.,

Shanghai, CN

IEC 80601-2-30; EN IEC 80601-2-30; ANSI AAMI IEC 80601-2-30; CAN/CSA C22.2 NO. 80601-2-30 Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement IS

Shenzhen CTL Testing Technology Co.,

Shenzhen, CN

IEC 80601-2-49; EN IEC 80601-2-49

Element Materials Technology Straubing GmbH Element Materials Technology Straubing

Straubing, DE

IEC 80601-2-49:2019 (2019-10-30) Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment IEC 60601-1-2 : 2014-02 Medical electrical

SGS Taiwan

Taoyuan City, TW

IEC 80601-2-30; EN IEC 80601-2-30; AAMI/IEC 80601-2-30; CSA C22.2 NO. 80601-2-30 Automated non-invasive sphygmomanometers IEC 80601-2-49; EN IEC 80601-2-49; ANSI/AAMI MP 80601-2-49; CAN/CSA C22.2 No. 80601-2-49 Multifunction pati

TÜV SÜD Product Service

Frankfurt/Main, DE

IEC 80601-2-58:2014 + A1:2016); Deutsche Fassung EN 80601-2-58:2015 + A1:2019 DIN EN 80601-2-58 : 2015-11⊗ - Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistun

Eurofins Product Service

Reichenwalde, DE

IEC 80601-2-49 : 2011-02 ⊗ Medical electrical equipment - Part 2-49: Particul ar requirements for the basic safety and essential performance of multifunction patient monitoring equipment IEC 60601-2-49 : 2011-02 ⊗ - Medical electrical e

IMQ SpA

Milano, IT

IEC 80601-2-26:2020/AC:2021, EN IEC 80601-2-26:2020/AC:2021/A1:2024, IEC 80601-2-26:2019, IEC 80601-2-26:2019/AMD1:2024 _ Par 04 - Prescrizioni generali/General requirements, Par 05 - Prescrizioni generali per le prove sugli apparecchi EM

Intertek Deutschland

Kaufbeuren, DE

IEC 80601 -2-26 : 2022 -04 ⊗ Medizinische elektrische Geräte - Teil 2-26: Besond ere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektroenzephalographen (IEC 80601-2- 26:2019); Deutsche Fassung EN

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

Shenzhen, Guangdong, CN

IEC 80601-2-30; EN IEC 80601-2-30; AAMI/IEC 80601-2-30; CSA C22.2 NO. 80601-2-30

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

Guangzhou, CN

IEC 80601-2-26; EN 80601-2-26; CAN/CSA-C22.2 No. 60601-2-26 Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment IEC 60601-2-

AA Electro Magnetic Test

Gurgaon, IN

IEC 80601-2-49 / IS 13450-2-49 Medical electrical equipment — Part 2- 61: Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 80601-2-61 Medical electrical equipment - Part 2-47: Parti

TUV Rheinland (Shanghai) Co.,

Shanghai, CN

IEC 80601-2-30; EN 80601-2-30; DIN EN 80601-2-30; VDE 0750-2-30; IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic res

ITL - International Testing Laboratories (CY)

Limassol, CY

IEC 80601-2-30, -35, -58, - 59, -60, -62, -71, -77,-78; ISO 80601-2-12, -13, -49, -55, - 56, -60, -61, -67, - 69, -70, -72, -74 , -79, -80, -85, -87, 90; SI 80601 Parts 2.12, 2.13, 2.56, 2.59, 2.60; CAN/CSA-C22.2 No. 80601-2-13,-

Intertek Testing Services NA

Kentwood, MI, US

IEC 80601-2-58:2014; ANSI/AAMI IEC 80601-2-77:2020; CAN/CSA C22.2 No. 601.1; CAN/CSA C22.2 No. 60601-1 (excluding 60601-1: Clause 9.5.2 Cathode Ray Tubes, Clause 11.4 MEE and MES intended for use with flammable anaesthetics, C

F2 Labs

Middlefield, OH, US

IEC 80601-2-59 Edition 2.0 2017-09 (Section(s) 201.17/202) 1; IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION; IEC 80601-2-60 Edition 2.0 2019-06 (Section(s) 201.17/202) 1; ISO 80601-2-61 Second Edition 2017-12 1 (Corrected ve

TÜV SÜD Product Service GmbH PS-SL-EMC / PS-SL-ENV-STR

Straubing, DE

IEC 80601-2-26 : 2019-05 IEC 80601-2-49 : 2018-03 IEC 80601-2-77 : 2019-07 ISO 7176-21 : 2009-04 AIM 7351731 Version 3 Gültig ab: 14.12.2023 Ausstellungsdatum: 14.12.2023 Electrical equipment for measurement, control and laboratory use - EM

TUV Rheinland of North America

Pleasanton, CA, US

IEC 80601-2-30 (Automated Non-Invasive BP)

cetecom advanced

Saarbrücken, DE

IEC 80601-2-30 : 2020-03 Medizinische elektr ische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven Blutdruckmessgeräten (IEC 80601-2-30:2

BUREAU VERITAS CONSUMER PRODUCTS SERVICES

Littleton, MA, US

IEC 80601-2-26 Medical Electrical Equipment - Part 2-26: Particular Requirements For The Basic Safety And Essential Performance Of Electroencephalograph IEC/EN 60601-2-27 Medical electrical equipment – Part 2-27: Particular requirements

SGS Korea Co., Ltd. (Gunpo Laboratory)

Gunpo-si, KR

Test Technology: Test Method(s) 1, 4: Product Safety Measurement Equipment2, 3 IEC/EN/KS C IEC/UL 61010-1; CAN/CSA C22.2 No. 61010-1; IEC/EN 61010-2-010; IEC/EN 61010-2-020; IEC/EN 61010-2-040; IEC/EN 61010-2-051; IEC/EN 61010-2-08

DEKRA Testing and Certification (Suzhou) Co.,

Suzhou, Jiangsu Province, CN

IEC 80601-2-30; EN IEC 80601-2-30; AAMI/IEC 80601-2-30; CSA C22.2 NO. 80601-2-30 Medical electrical equipment – Part 2-60: Particular requirements for basic safety and essential performance of dental equipment IEC 80601-2-60; EN I

UL Verification Services

Fremont, CA, US

(A2LA Certificate No. 0751.05) Revised 03/02/2026 Page 3 of 10 Test Technology: Test Method(s) 1, 2: EMC Medical (continued) IEC/EN 60601-2-25 (cl. 202 only); IEC/EN 60601-2-27 (cl. 202 only); IEC/EN 60601-2-31 (cl. 202 only); IEC/EN

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

Republic Of, DE

IEC 80601 -2-30:2009 +AMD1:2013 SIST EN 80601-2-30:2010+ +AMD1:2015 IEC 80601-2-30:2018 SIST EN 80601-2-30:2019 Medical electrical equipment - Part 2 -30: Particular requirements for basic safety and essential performance of automa

TUV Rheinland (China)

Beijing, CN

IEC 80601-2-77 Edition 1.0 2019-07 6-438 3 This laboratory is only accredited for testing ac tivities outlined within the test methods listed above. Reference to any other activity with in these standards, such as risk management or ri

Centre Testing International Group Co.,

Shenzhen, Guangdong, CN

IEC 80601-2-77 Edition 1.0 2019-07 6-438 ISO 80601-2-79 First Edition 2018-07 1-143 IEC TR 60601-4-2 Edition 1.0 2016-05 19-19 IEC TS 60601-4-2 Edition 1.0 2024-03 19-50 1These methods have been assessed by A2LA according to A2LA’s F

Element Materials Technology - Hull

Kingston upon Hull, GB

IEC 80601-2-49:2018 Ed.1.0 (Only Section 202.8.102); AIM Standard 7351731 Rev. 3.00 2021-06-04 (Only Annex A, B, C and D devices only) EMC – Commercial Unintentional Radiated & Conducted Emissions CISPR 11:2015 +A1:2016 & A2:2019;

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