IEC 60601-1-11 Accredited Testing Labs in United States
10 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-1-11 testing. Accredited providers include WESTPAK, DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou Branch, TUV Rheinland (Shanghai) Co.,, Packaging Compliance, Intertek Testing Services NA. Sites located in Kentwood, MI, San Jose, CA, Guangzhou, Shanghai, Tempe, AZ.
Accredited Labs
(A2LA Cert. No. 2870.03) 12/29/2025 Page 2 of 2 Test Test Method(s) Compression Testing Compression Testing ASTM D642 Compression Test of Containers TAPPI T804 Environmental Conditioning Environmental Conditioning ASTM D4332
(A2LA Cert. No. 6568.01) Revised 10/21/2025 Page 2 of 21 Test Technology: Test Method(s)1 : Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance – Collateral standard: Requirem
(A2LA Cert. No. 4301.01) Revised 11/07/2025 Page 2 of 71 Test Technology: Test Method(s) 1: Medical electrical equipment − Part 1-8: General requirements for basic safety and essential performance − Collateral standard:
(A2LA Cert. No. 3774.02) 11/21/2025 Page 2 of 2 Tests: Test method(s): Altitude and Pressure MIL STD 810; ASTM D6653; RTCA/DO-160; IEC 60068-2-13, 60068-2-39, 60068-2-40, 60601-1-11 Medical Package Integrity Test
(A2LA Cert. No. 2085.01) Revised 01/22/2026 Page 2 of 9 Test Technology: Test Method(s): 1, 2 Product Safety (continued) Medical 2 (excluding Expelled Parts; Flammable Gases and Oxygen Bomb) IEC 60601-13; EN 60601-13; UL 60
(A2LA Cert. No. 3661.01) 04/04/2025 Page 3 of 4 Test: Test Method(s)1: Temperature/Humidity2 (5 to 95) %RH (continued) MIL-STD-1576 (All); RTC
(A2LA Cert. No. 3235.01) Revised 01/23/2026 Page 14 of 18 Test(s): Test Method(s) 1,2: Medical devices - Application of usability engineering to medical devices I
(A2LA Cert. No. 3392.01) Revised 06/02/2025 Page 8 of 14 Usability (continued) IEC 62366-1; IEC 62366-1:2015; ANSI/AAMI/IEC 62366-1; ANSI/AAMI/IEC 62366-1:2015; CAN/CSA-IEC 62366-1; CAN/CSA-IEC 62366-1:2015; EN 62366-1;
(A2LA Cert. No. 4896.01) Revised 12/17/2025 Page 4 of 4 2 These methods have been assessed by A2LA according to A2LA’s FDA ASCA Program requirements. Accreditation by A2LA does not imply FDA ASCA-Accreditation. All ASCA-a
(A2LA Cert. No. 7375.01) Revised 02/03/2026 Page 22 of 26 Test Technology: Test Method(s): Clause 12 of IEC 60601-1-11, Clause 12 of EN 60601-1-11 Radio Communications Intentional Radiators US (FCC) Intentional Radiators FCC P
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.