Proficiency testing catalogue: medical devices
Name | Planned shipping method | Start Date | ||
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Identification of microorganisms using MALDI-ToF Parameters (qualitative): identification of microorganism MALDI-ToF Article Number: 2010657 Category: immunological, molecular biological and microbiological testing medical devices medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 2 |
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November 2025 | Add to cart | |
Identification of microorganisms using MALDI-ToF Parameters (qualitative): identification of microorganism MALDI-ToF Article Number: 2010657 |
November 2026 | Add to cart | ||
Medical devices - detection of endotoxins (Ph. Eur. 2.6.14) Parameters (qualitative): endotoxins Article Number: 2011291 Description: The Limulus amoebocyte lysate test (=LAL test) according to Ph. Eur. 2.6.14 is used to detect bacterial endotoxins. It is also possible to participate in the proficiency test with comparable methods, e.g. USP chapter 85, USP chapter 161, JP chapter 4.01. and ISO 11737-3. 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 |
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October 2025 | Add to cart | |
Medical devices - detection of endotoxins (Ph. Eur. 2.6.14) Parameters (qualitative): endotoxins Article Number: 2011291 |
October 2026 | Add to cart | ||
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 |
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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 |
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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 |
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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 |
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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 - 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. |
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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 |
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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 | ||
Microbial barrier testing of packaging materials Parameters (qualitative): microbial barrier Article Number: 2010283 Category: immunological, molecular biological and microbiological testing medical devices medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 |
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November 2025 | Add to cart | |
Microbial barrier testing of packaging materials Parameters (qualitative): microbial barrier Article Number: 2010283 |
November 2026 | Add to cart | ||
Microbiological analysis of dialysis water 1 Parameters (quantitative): Aerobic total count 36 °C, Aerobic total count 20 °C Article Number: 2011296 Description: Proficiency test series for testing water for haemodialysis and related therapies for microbiological requirements. This part deals with the counting of viable microorganisms (total microbial count) according to ISO 23500. Other methods for water quality according to e.g. ISO 6222, mineral/table water regulation and drinking water regulation. Category: immunological, molecular biological and microbiological testing medical devices medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 New proficiency testing |
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October 2025 | Add to cart | |
Microbiological analysis of dialysis water 1 Article Number: 2011296 |
October 2026 | Add to cart |
Unter Umständen kann es vorkommen, dass dieser Parameter im Ringversuch nicht zur Verfügung steht.