Proficiency testing catalogue
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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 - ethylene oxide residues (ISO 10993-7) 1 Parameters (quantitative): ethylene oxide (CAS 75-21-8) [mg/kg], ethylene chlorohydrin (CAS 107-07-3) [mg/kg] Article Number: 2010375 Description: Extraction by simulated application (reference method) in water 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. |
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September 2025 | Add to cart | |
Medical devices - ethylene oxide residues (ISO 10993-7) 1 Article Number: 2010375 |
September 2026 | Add to cart | ||
Medical devices - ethylene oxide residues (ISO 10993-7) 2 Parameters (quantitative): ethylene oxide (CAS 75-21-8) [mg/kg], ethylene chlorohydrin (CAS 107-07-3) [mg/kg] Article Number: 2010377 Description: Exhaustive extraction 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. |
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September 2025 | Add to cart | |
Medical devices - ethylene oxide residues (ISO 10993-7) 2 Article Number: 2010377 |
September 2026 | Add to cart | ||
Medical devices - extractables & leachables Parameters (qualitative): identification of various extractables & leachables Parameters (quantitative): quantification of the identified extractables & leachables [µg/ml] Article Number: 2011169 Category: chemical-physical testing medical devices medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. New parameter selection |
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August 2025 | Add to cart | |
Medical devices - extractables & leachables Parameters (qualitative): identification of various extractables & leachables Article Number: 2011169 |
August 2026 | Add to cart | ||
Medical devices - extraction of elements (ISO 10993-12) Parameters (quantitative): calcium (Ca), phosphorus (P), magnesium (Mg), fluorine (F), manganese (Mn), chromium (Cr), Iodine (I), selenium (Se) Article Number: 2011159 Category: chemical-physical testing medical devices medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. |
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September 2025 | Add to cart | |
Medical devices - extraction of elements (ISO 10993-12) Article Number: 2011159 |
September 2026 | Add to cart | ||
Medical devices - extraction of metals (ISO 10993-12) Parameters (quantitative): zinc (Zn) [µg/l], nickel (Ni) [µg/l], cadmium (Cd) [µg/l], lead (Pb) [µg/l], copper (Cu) [µg/l], cobalt (Co) 1 [µg/l], chromium (Cr) 1 [µg/l], arsenic (As) 1 [µg/l] Article Number: 2010379 Description: Extraction of the samples with water 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. |
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May 2025 | Add to cart | |
Medical devices - extraction of metals (ISO 10993-12) Article Number: 2010379 |
June 2026 | Add to cart | ||
Medical devices - gravim. determination extractables Parameters (quantitative): extractables (n-hexane) [mg/dm²], extractables (iso-propanol) [mg/dm²] Article Number: 2011168 Description: If you are interested in testing aqueous simulants, e.g. ethanol 10% or dist. Water, please have a look at our proficiency tests for global migration in the field of consumer goods. Category: chemical-physical testing medical devices medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. |
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June 2025 | Add to cart | |
Medical devices - gravim. determination extractables Article Number: 2011168 |
July 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 |
Unter Umständen kann es vorkommen, dass dieser Parameter im Ringversuch nicht zur Verfügung steht.