11 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 80601-2-61 testing. From the accredited scope text: “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:” “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” “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,” “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”
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
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
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.
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
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;
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;
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
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
Littleton, MA, US
Product Safety Standard 1,2: Title: ISO 80601-2-12 Medical electrical equipment – Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators IEC/EN 60601-2-16 Medical electrical equi
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
San Diego, CA, US
Testing Activities performed under the scope of the U.S FDA ASCA Pilot Program Specifications: Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standard
This page is a fixed slice of the register: every ISO 80601-2-61 scope we hold for United States. Search narrows it further by city, accreditation body, or a term from the scope text itself.
Search labs in United StatesAmerican 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.