Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts

Affiliations

• ¹ National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. Electronic address: [email protected].
• ² Seh consulting + services, Paderborn, Germany.
• ³ Nelson Laboratories, Inc., Salt Lake City, UT, USA.
• ⁴ MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia.
• ⁵ EPISKIN, Lyon, France.
• ⁶ National Institute of Health Sciences (NIHS), Division of Medical Devices, Tokyo, Japan.
• ⁷ Arthrex, Inc., Naples, FL, USA(1).
• ⁸ NAMSA, Northwood, OH, USA.
• ⁹ Cyprotex US LCC, Kalamazoo, MI, USA(2).
• ¹⁰ MatTek Corporation, Ashland, MA, USA.
• ¹¹ American Preclinical Services LLC, Minneapolis, MN, USA.
• ¹² US Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
• ¹³ WuXi AppTec, St Paul, MN, USA.
• ¹⁴ Becton Dickinson, Research Triangle Park, NC, USA.
• ¹⁵ Eurofins Biolab Srl, Vimodrone, Milan, Italy.
• ¹⁶ SP Technical Research Institute of Sweden, Borås, Sweden.
• ¹⁷ Yonsei University, College of Dentistry, Seoul, South Korea.
• ¹⁸ Eurofins Biopharma, Planegg, Munich, Germany.
• ¹⁹ VitroScreen, Milan, Italy.
• ²⁰ Envigo CRS GmbH, Rossdorf, Germany.
• ²¹ NAMSA, Chasse sur Rhône, France.
• ²² National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
• ²³ Arthrex, Inc., Naples, FL, USA.
• ²⁴ Medtronic, plc, Minneapolis, MN, USA.