4 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 62304 testing. From the accredited scope text: “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; A” “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 abov” “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/CS”
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
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
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;
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
This page is a fixed slice of the register: every IEC 62304 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.