ISO 80601-2-61 Accredited Testing Labs in United States
13 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 80601-2-61 testing. These labs commonly handle Medical Equipment matrices. Accredited providers include TUV SUD Certification and Testing (China) Co.,, SGS-CSTC Standards Technical Services (Shanghai) Co.,, Eurofins Electrical Testing Service (Shenzhen) Co.,, MedTech Testing Solution Co.,, Shenzhen CTL Testing Technology Co.,. Sites located in Shenzhen, Guangdong, Wuxi, Xinqiao, Songjiang, Shanghai, Shenzhen City, Guangdong, New Taipei City.
Accredited Labs
(A2LA Cert. No. 7315.01) Revised 01/06/2026 Page 6 of 7 Test Technology: Test Method(s) 1: ISO 80601-2-13 First edition 2011-08-11; ISO 80601-2-13 Second edition 2022-04; IEC 60601-2-18: Edition 3.0 2009-08; IEC 60601-2-19 Editi
(A2LA Cert. No. 6332.01) REVISED 01/15/2026 Page 14 of 23 Test Technology: Test Method(s)2,3: Medical Equipment (Continued) IEC 60601-2-436
(A2LA Cert. No. 5376.01) Revised 02/09/2026 Page 12 of 18 Test Technology: Test Method(s) 2,3,4: Part 2-30: Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometers
(A2LA Cert. No. 7331.01) Revised 07/29/2025 Page 4 of 6 Test Technology: Test Method(s) 1: High intensity therapeutic ultrasound (HITU) equipment IEC 60601-2-62; EN 60601-2-62; BS EN 60601-2-62; AS/NZS IEC 60601.2.62; CAN/CSA
(A2LA Cert. No. 4343.01) 01/26/2026 Page 10 of 13 Test: Test Method(s) 1: Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type ISO 8106
(A2LA Cert. No. 3470.02) 01/13/2026 Page 3 of 5 Tests (Parameters): Standard(s)1,2: Dental intra-oral X-ray equipment IEC 60601-2-65; EN 60601-2-65; CAN/CSA-C22.2 No. 60601-2-65 Robotically assisted surgical equipment IEC 60601
(A2LA Cert. No. 3816.01) 06/24/2025 Page 14 of 23 Test Technology: Test Method(s)2: Medical Equipment (continued) IEC 60601-2-
(A2LA Cert. No. 6568.01) Revised 10/21/2025 Page 5 of 21 Test Technology: Test Method(s)1 : Medical electrical equipment – Part 2-57: Particular requirements for basic safety and essential performance of non-laser light source e
(A2LA Cert. No. 1427.01) 02/27/2026 Page 6 of 8 Test Technology: Test Method(s) 2,3: Medical (cont.) IEC 60601-2-44 (Ed. 1; Ed. 2 + Am1; Ed. 3 + Am1 + Am2); IEC 60601-2-44 Edition 3.2:2016; IEC 60601-2-45 (Ed. 1; Ed. 2; Ed
(A2LA Cert. No. 3331.02) Revised 01/28/2026 Page 3 of 12 Test Description: Test Method(s) 1,2: Medical 2 (cont.) IEC 60601-2-28 3 (X-ray source assemblies and X-ray tube assemblies for medical diagnosis) IEC 60601-2-30 (Automatic
(A2LA Cert. No. 1627.01) 10/14/2025 Page 20 of 24 Product Safety Standard 1,2: Title: IEC/EN 60601-2-52 Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of med
(A2LA Cert. No. 3061.01) 01/16/2025 Page 5 of 11 Test Technology: Test Method(s)3: IEC 60601-2-47; EN 60601-2-47; ANSI/AAMI IEC 60601-2-50; IEC 60601-2-50 /EN60601-2-50; IEC 60601-2-52; EN 60601-2-52; ISO 80601-2-55; EN ISO 8060
(A2LA Cert. No. 3392.01) Revised 06/02/2025 Page 9 of 14 Infusion Pumps and Controllers IEC 60601-2-24; Electroencephalographs IEC 80601-2-26; Automated Non-Invasive Sphygmomanometers IEC 80601-2-30; Heating Devices Usi
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About ISO/IEC 17025 in United States
American Association for Laboratory Accreditation (A2LA) is the primary accreditation body issuing ISO/IEC 17025 accreditation for testing laboratories in United States.
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. Accreditation to this standard provides independent confirmation that a laboratory operates a quality management system and is technically competent to produce valid results within its declared scope.
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