Proficiency testing catalogue: medical devices
Name | Planned shipping method | Start Date | ||
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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 B 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 e.g. by DSC or FTIR 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 |
Unter Umständen kann es vorkommen, dass dieser Parameter im Ringversuch nicht zur Verfügung steht.