4 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 10993-12 testing. From the accredited scope text: “ISO 10993-12: Fourth Edition 2012-07-01, Biological Evaluation of Medical Devices -Part 12: Sample Preparation and Reference Materials 1These methods have been assessed by A2LA according to A2LA’s FDA” “ISO 10993-12 Determination of Elementary Inorganic Extractables in Medical Devices by ICP-MS ISO 10993-18 Determination of Exhaustive Extraction of Medical Devices by Non-Volatile Residue Analysis ISO”
Hercules, CA, US
Test(s): Test Method(s): Elution USP <87> USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993- 12 Biological LAL Bacterial Endotoxins USP <85> and <161>; ANSI/AAMI ST72:2011. EP 2.6.14, Bacterial Endo toxins Microbiolo
St. Paul, MN, US
Test/Technology: Internal Test Method(s)2: External Test Method2: Materials (Including Medical Devices) (cont.): Semi-Volatiles (GC/MS)* LABENV-021 EPA 8270E ISO 10993: Part 18 <USP 1663> Thermal Gravimetric Analysis (TGA) EQUIP-08
Alpharetta, GA, US
ISO 10993-12 Determination of Elementary Inorganic Extractables in Medical Devices by ICP-MS ISO 10993-18 Determination of Exhaustive Extraction of Medical Devices by Non-Volatile Residue Analysis ISO 10993-18 Determination of Non-V
Mendota Heights, MN, US
ISO 10993-12: Fourth Edition 2012-07-01, Biological Evaluation of Medical Devices -Part 12: Sample Preparation and Reference Materials 1These methods have been assessed by A2LA according to A2LA’s FDA ASCA Program requirements. Accred
This page is a fixed slice of the register: every ISO 10993-12 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.