IEC 62304 Accredited Testing Labs Worldwide

18 accredited laboratories in 8 countries hold IEC 62304 in their ISO/IEC 17025 scope. Primary accreditors include American Association for Laboratory Accreditation.

Total labs

Countries

Available in 8 Countries

China

6 labs

Canada

2 labs

Taiwan

2 labs

Japan

1 lab

Finland

1 lab

United Kingdom

1 lab

Top matrices for IEC 62304

Medical equipment, electrical safety and EMC

Sample labs

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

China, DE

IEC 62304; IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION; ANSI AAMI IEC 62304; ANSI AAMI IEC 62304:2006/A1:2016; CSA CEI/IEC 62304; EN 62304 IEC 62366-1; IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION; ANSI AAMI IEC 6236

Intertek Japan K.K.

Tokyo, JP

IEC 62304; IEC 62366; IEC 62366-1; 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

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

Guangzhou, Guangdong, CN

IEC 62304; EN 62304; ISO 20417; EN ISO 20417; ISO 80369-2; ISO 18190 (except clasue 6.1.2, 6.1.3) Ultrasound Equipment: IEC 62359; EN 62359; NEMA UD 2; NEMA UD 3; IEC 61689; EN IEC 61689; IEC 60601-2-37; EN 60601-2-37; CSA C22.2 NO

TÜV Rheinland Japan Ltd. Yokohama Laboratories Global Technology Assessment Center

Japan, DE

IEC 62304:2006 + A1:2015 EN 62304:2006 + A1:2015 DIN EN 62304: 2016 VDE 0750-101:2016 Medical Device soLware - SoLware life cycle processes. A Product Safety IEC 62366:2007 EN 62366:2008 DIN EN 62366:2008 VDE 0750-241

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

Xinqiao, Songjiang, Shanghai, CN

IEC 62304; CAN/CSA ISO 10079-1; CAN/CSA ISO 10079-2; CAN/CSA ISO 10079-3; CAN/CSA ISO 10079-4; CSA ISO 15197; GB/T 37704 Exclusions for IEC 60601-15, EN 60601-1, ANSI/AAMI ES 60601-15, CAN/CSA C22.2 No. 60601-1 Cl. 8.8.4.2 Rubber

TUV SUD Canada

Gormley, ON, CA

IEC 62304; IEC 62366; IEC/ISO 80601-2, CSA 80601-2 (including all particular standards); UL/CSA IEC 60065-1; IEC/EN 60335-2 (All Inclusive); UL 60335-89; IEC/EN 60601-1-4; EN 60601-2-2; IEC 60601-2-2; IEC 60601-2-2 Edition 6.0 2017-03

Intertek Testing Services NA

Duluth, GA, US

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; UL 61010-1, Ed. 2.0; CSA C22.2 No. 61010-1 Ed. 2.0; AS 61010-1 Ed. 2.0; ANSI/UL 61010-1 3rd Ed. (R201

MEGALAB Group

Aurora, ON, CA

IEC 62304; IEC 62366; UL/CSA/IEC/EN 62368-1; IEC/EN 62368-x (All Inclusive); IEC 60065-1; IEC 60950-1; IEC/EN 60950-22; UL/CSA.IEC/EN 60335-1; UL/CSA/IEC/EN 60335-2 (including all particular standards); UL/CSA/IEC/EN 60730-1; UL/

MedTech Testing Solution Co.,

New Taipei City, TW

IEC 62304; EN 62304; BS EN 62304; CAN/CSA CEI/IEC 62304; JIS T 2304; ANSI AAMI IEC 62304 Laboratory Equipment – Electrical equipment for measurement, control, and laboratory use IEC 61010-1; EN 61010-1; BS EN 61010-1; ANSI/

Eurofins Electrical Testing Service (Shanghai) Co.,

Shanghai, CN

IEC 62304; EN 62304; ANSI AAMI IEC 62304; CSA IEC 62304 Electromagenetic Compatibility Conducted Emissions Only ANSI C63.4:2014; EN 55011; EN 55014-1; EN IEC 55014; EN 55032; EN IEC 55015; IEC 61326-1; EN 61326-1; EN IEC

SGS Taiwan

Taoyuan City, TW

IEC 62304, EN 62304, ANSI/AAMI 62304, JIS T2304 Usability IEC 60601-1-6; EN 60601-1-6; CAN/CSA-C22.2 No. 60601-1-6; IEC 62366; EN 62366; ANSI/AAMI/IEC 62366; CAN/CSA-IEC 62366; IEC 62366-1; EN 62366- 1; CAN/CSA-IEC 62366-1; ANSI/AAM

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

Shenzhen, Guangdong, CN

IEC 62304; EN 62304; ANSI/AAMI/IEC 62304; CSA CEI/IEC 62304A; IEC 82304-1; EN 82304-1; ISO 20417; EN ISO 20417; CSA C22.2 No. 60601-2-1; CSA C22.2 No. 60601-2-35; CSA C22.2 No. 80601-2-85; CSA C22.2 No. 80601-2-87; CSA C22.2 No.

Intertek Testing Services NA

Kentwood, MI, US

IEC 62304; IEC 62366; IEC 62366-1; UL 60601-1; AS/NZS 3200; ANSI/AAMI ES60601-1; ANSI/AAMI ES60601-1: 2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2: 2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (The above standards exclude 60601

TUV Rheinland (China)

Beijing, CN

IEC 62304:2006+A1:2015; EN 62304:2006+A1:2015; IEC 60601-2-22:2019; EN IEC 60601-2-22:2020; IEC 60601-2-52:2009+A1:2015; EN 60601-2-52:2010+AC:2011+A1:2015; IEC 60601-2-37:2007+A1:2015; EN 60601-2-37:2008+A11:2011+A1:2015; IEC 60601

Element Materials Technology - Hull

Kingston upon Hull, GB

IEC 62304:2015 1.1 Edition; IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION; ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021]; CSA CAN/CSA-C22.2 No. 60601-1-12:15 + A1:21 Medical electrical equipment — Part 1-12; IEC 60601

Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

IEC 62304; IEC 62304:2006; EN 62304; EN 62304:2006; ANSI/AAMI/IEC 62304; ANSI/AAMI/IEC 62304:2006; CAN/CSA CEI/IEC 62304; YY/T 0664:2020; YY/T 0664:2008;

SGS Fimko

Helsinki, FI

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 SUD America

San Diego, CA, US

IEC 62304 (1Ed 2006+A1:2015); EN 62304 (2006); AAMI IEC 62304 (2006); CAN/CSA-CEI/IEC 62304 (2014); IEC 62366 (1Ed 2007+A1:2014); IEC 62366:2015+A1:2020; EN 62366 (2008); AAMI IEC 62366 (2007); CAN/CSA-IEC 62366 (2014); CS