Irritation testing

DIN EN ISO 10993-23:2021

The present test is designed to predict and classify the skin irritant potential of extracts from medical devices according to the requirements of ISO standards 10993-1:2009, 10993-5:2009, 10993-10:2010, and 10993-12:2012 using the RhE model EpiDerm™ (EPI-200) and parameters related to skin irritation. 3D human reconstructed skin models are exposed to an extract of the medical device for at least for 18 hours. After exposure supernatant can be collected for the analysis of cytokines (e.g. IL-1α, optionally). Subsequently, models are rinsed and vitality is assessed by MTT-test (colorimetric assay). If remaining vitality is > 50 %, the medical devices had no irritation potential.

Prediction Model

Mean tissue viability
(expressed as % of negative control)
> 50 % non-irritant (NI)
≤ 50 % irritant (I)


Rufen Sie uns unter 0251 481637-0 an oder senden Sie eine Nachricht. Wir melden uns umgehend bei Ihnen.
Welche Daten im Einzelnen gespeichert werden und wer Zugriff auf diese hat, erfahren Sie in unserer Datenschutzerklärung.

Ich stimme der Speicherung und Nutzung meiner Daten laut Datenschutzerklärung zu und bin mit der Verarbeitung meiner Daten innerhalb der Dermatest GmbH für die Beantwortung meiner Kontakt- oder Informationsanfrage einverstanden.

Meine Einwilligungen kann ich jederzeit für die Zukunft widerrufen.

Quick request

Call us on 0251 481637-0 or send an email. We will get back to you straight away.
You can find details about what personal data we store and who has access to it in our data protection policy.

I consent to my personal data being stored and processed in line with the data protection policy and I consent my personal data being processed by Dermatest GmbH in order to answer my contact or information request.

I can withdraw my consent at any time with immediate effect.