Name Planned shipping method Start Date  
Medical devices - in vitro eye irritation (OECD492b)
Parameters (qualitative): in vitro eye irritation
Article Number: 2011290
Description: With the SkinEthic Human Corneal Epithelium (HCE) Time-to-Toxicity (TTT) test the eye irritation shall be tested with a reconstructed human corneal epithelium (HCE) according to OECD492b. The samples should be classified according to UN GHS Cat. 1, Cat. 2 and No Cat. The samples are a simulated extract. The extraction of a medical device is not part of the proficiency test.
Category: immunological, molecular biological and microbiological testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping September 2025 Add to cart
Medical devices - in vitro eye irritation (OECD492b)
Parameters (qualitative): in vitro eye irritation
Article Number: 2011290
September 2026 Add to cart
Medical devices - in vitro skin irritation (ISO 10993-23)
Parameters (qualitative): skin irritation
Article Number: 2011286
Description: The samples are extracted in accordance with ISO 10993-23 under conditions specified by us. Irritation is tested with both the polar and the non-polar extract using the EpiDerm or the EpiSkin model. The viability determined using the MTT assay is tested qualitatively (pass / not pass).
Category: immunological, molecular biological and microbiological testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping October 2025 Add to cart
Medical devices - in vitro skin irritation (ISO 10993-23)
Parameters (qualitative): skin irritation
Article Number: 2011286
October 2026 Add to cart
Medical devices - in vitro skin sensitisation (OECD 442D,KeratinoSens)
Parameters (qualitative): skin sensitisation
Article Number: 2011288
Description: The activation of keratinocytes is to be investigated using the ARE-Nrf2 luciferase KeratinoSens test method (OECD 442D Appendix IA). The samples are a simulated extract. The extraction of a medical device is not part of the proficiency test.
Category: immunological, molecular biological and microbiological testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping December 2025 Add to cart
Medical devices - in vitro skin sensitisation (OECD 442D,KeratinoSens)
Parameters (qualitative): skin sensitisation
Article Number: 2011288
December 2026 Add to cart
Medical devices - in vitro skin sensitisation (OECD 442E, h-CLAT)
Parameters (qualitative): skin sensitisation, CD86, CD54
Article Number: 2011289
Description: The activation of the dendritic cells is to be investigated using the Human Cell Line Activation Test (h-CLAT) (OECD 442E, ANNEX 1). The samples are a simulated extract. The extraction of a medical device is not part of the proficiency test.
Category: immunological, molecular biological and microbiological testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping December 2025 Add to cart
Medical devices - in vitro skin sensitisation (OECD 442E, h-CLAT)
Parameters (qualitative): skin sensitisation, CD86, CD54
Article Number: 2011289
December 2026 Add to cart
Medical devices - loss of polymer mass (ISO 10993-13) 1
Parameters (quantitative): mass loss of the sample in the test solution water [mg]
Article Number: 2010391
Description: Accelerated degradation test (ISO 10993-1 point 4.2) at 70°C
Category: chemical-physical testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
Suitable laboratory equipment is required for participation in the proficiency testing schemes.
Frozen shipping August 2025 Add to cart
Medical devices - loss of polymer mass (ISO 10993-13) 1
Article Number: 2010391
August 2026 Add to cart
Medical devices - loss of polymer mass (ISO 10993-13) 2
Parameters (quantitative): mass loss of the sample in the test solution water [mg]
Article Number: 2010393
Description: Real-time degradation test (ISO 10993-1 point 4.3) at 37°C
Category: chemical-physical testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
Suitable laboratory equipment is required for participation in the proficiency testing schemes.
Frozen shipping August 2025 Add to cart
Medical devices - loss of polymer mass (ISO 10993-13) 2
Article Number: 2010393
August 2026 Add to cart
Medical devices - protein residues
Parameters (quantitative): protein [µg]
Article Number: 2010961
Category: immunological, molecular biological and microbiological testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
Suitable laboratory equipment is required for participation in the proficiency testing schemes.
Frozen shipping September 2025 Add to cart
Medical devices - protein residues
Article Number: 2010961
September 2026 Add to cart
Medical devices - pyrogenic monocyte activation test (Ph. EP 2.6.30)
Parameters (qualitative): monocyte activation, IL-6
Article Number: 2011287
Description: The samples are analyzed according to the semi-quantitative method from Ph. EP 2.6.30. The samples are a simulated extract. The extraction is not part of the proficiency test. An endotoxin standard is provided by us for better comparability. The activation of the monocytes should preferably be determined using human IL-6 ELISA. The proficiency test is evaluated qualitatively.
Category: immunological, molecular biological and microbiological testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping November 2025 Add to cart
Medical devices - pyrogenic monocyte activation test (Ph. EP 2.6.30)
Parameters (qualitative): monocyte activation, IL-6
Article Number: 2011287
November 2026 Add to cart
Medical devices - qual. characterization (ISO 10993-18)
Parameters (qualitative): qual. characterization of medical devices
Article Number: 2010381
Description: Qualitative determination of medical devices made of plastic, e.g. using DSC or FTIR. The samples may also contain parts that are not made of plastic, e.g. paper or metals. For successful participation in this proficiency test, these components must also be correctly characterized. This may require methods such as XRF or SEM-EDS.
Category: chemical-physical testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
Suitable laboratory equipment is required for participation in the proficiency testing schemes.
Shipping at room temperature July 2025 Add to cart
Medical devices - qual. characterization (ISO 10993-18)
Parameters (qualitative): qual. characterization of medical devices
Article Number: 2010381
July 2026 Add to cart
Medical devices - quan. characterization (ISO 10993-18) - Formaldehyde
Parameters (quantitative): formaldehyde (CAS 50-00-0) [mg/kg]
Article Number: 2010385
Description: Extraction and determination of formaldehyde content in medical devices
Category: chemical-physical testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
Suitable laboratory equipment is required for participation in the proficiency testing schemes.
Frozen shipping July 2025 Add to cart
Medical devices - quan. characterization (ISO 10993-18) - Formaldehyde
Article Number: 2010385
July 2026 Add to cart
1 Parameter mit dieser Kennzeichnung sind abhangig von der Teilnehmerzahl und/oder der Materialauswahl.
Unter Umständen kann es vorkommen, dass dieser Parameter im Ringversuch nicht zur Verfügung steht.