5 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 10993-5 testing. From the accredited scope text: “ISO 10993-5: Third Edition 2009-06-01, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity Intracutaneous Reactivity Irritation Buehler Sensitization Test Primary Skin I” “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 Microbiological Antimicrobial Effectiven” “ISO 10993-5” “ISO 10993-5 USP <87> CC-0002 CC-0006 Detection of Mycoplasma and Virus by PCR EU 2.6.7 PC-0005 PC-0007 PC-0011 MY-0008 Detection of Virus in Test Articles USP <1050> USP <1237> VI-0002”
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
Brooklyn Park, MN, US
ISO 10993-5 Neutral Red Uptake (NRU) Q08-WI-001759 CHEMICAL Test Method(s) Laboratory Procedure Ethylene Oxide Residue (Oxide, Chlorohydrin) ISO 10993-7 Q08-WI-001745 Total Organic Carbon Testing USP <643> Q08-WI
Concord, CA, US
ISO 10993-5 USP <87> CC-0002 CC-0006 Detection of Mycoplasma and Virus by PCR EU 2.6.7 PC-0005 PC-0007 PC-0011 MY-0008 Detection of Virus in Test Articles USP <1050> USP <1237> VI-0002
Mendota Heights, MN, US
ISO 10993-5: Third Edition 2009-06-01, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity Intracutaneous Reactivity Irritation Buehler Sensitization Test Primary Skin Irritation ISO 10993-10: Third Edit
New York, NY, US
ISO 10993-5
This page is a fixed slice of the register: every ISO 10993-5 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.