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ISO 10993-12 Accredited Testing Labs in United States

5 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 10993-12 testing. These labs commonly handle Medical devices matrices. Most frequently tested analytes via this method in United States: Elementary Inorganic Extractables, Irritation, Pyrogen. Accredited providers include TUV SUD America, NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA), STC (Guangdong) Company, WuXi AppTec Co.,, Kobay Deney Hayvanlari Laboratuari San. ve Tic.. Sites located in Alpharetta, GA, Mendota Heights, MN, Guangdong, Suzhou, Ankara.

Labs
5
Top matrix
Medical devices
3 labs
Top analyte
Elementary Inorganic Extractables
1 labs
Primary AB
A2LA
5 labs

Accredited Labs

TUV SUD America
Alpharetta, GA, US

(A2LA Cert. No. 2955.22) 02/27/2025 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 TUV SUD AMERICA, INC. 141 14th Street NW New Brighton, MN 55112 Shannon Carver Phone: 651-955-5546 Shannon.Carver@tuvsud.com CHEMICAL V

NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA)
Mendota Heights, MN, US

(A2LA Cert. No. 2785.01) Revised 07/10/2025 Page 3 of 3 ASCA Biocompatibility Testing Activities performed under the scope of the U.S FDA ASCA Pilot Progr

STC (Guangdong) Company
Guangdong, US

(A2LA Cert. No. 7317.01) 08/30/2024 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 STC (Guangdong) Company Limited No.68, Fumin South Road, Dalang Dongguan, Guangdong, China Glenna Zhou

WuXi AppTec Co.,
Suzhou, US

(A2LA Cert. No. 6240.01) 12/9/2025 Page 11 of 14 Test Standard or Test Method(s) Clean Room (Zone) ISO 14644-1: Curre

Kobay Deney Hayvanlari Laboratuari San. ve Tic.
Ankara, US

(A2LA Cert. No. 7072.01) 10/21/2025 Page 1 of 2 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 KOBAY DENEY HAYVANLARI LABORATUARI SAN. VE TIC. AS Beytepe Mah. 1748. Sok. No:20/1 Cankaya / Ankara. Ostim OD

Top matrices for ISO 10993-12 in United States

Top analytes for ISO 10993-12 in United States

  • Elementary Inorganic Extractables (1)
  • Irritation (1)
  • Pyrogen (1)
  • Syphacia Spp. (1)

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.

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All accredited testing labs in United States