Proficiency testing catalogue: medical devices
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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 Sterility and contamination testing Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 1 Is currently underway. Can still be booked. |
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October 2025 | Add to cart | |
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Identification of microorganisms using MALDI-ToF Parameters (qualitative): identification of microorganism MALDI-ToF Article Number: 2010657 |
November 2026 | Add to cart | ||
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Identification of microorganisms using MALDI-ToF Parameters (qualitative): identification of microorganism MALDI-ToF Article Number: 2010657 |
November 2027 | Add to cart | ||
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Medical devices - degradation products from ceramics (ISO 10993-14) 1 Parameters (quantitative): mass of the filter residue [mg], mass of the dissolved material [mg] Article Number: 2010387 Description: Testing with the extreme value solution (ISO 10993-14 part 4.4) Category: chemical-physical testing medical devices Non-active 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 2026 | Add to cart | |
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Medical devices - degradation products from ceramics (ISO 10993-14) 1 Article Number: 2010387 |
May 2027 | Add to cart | ||
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Medical devices - degradation products from ceramics (ISO 10993-14) 2 Parameters (quantitative): quantitative determination of the elements in the test solution [mg/kg] Article Number: 2010389 Description: Testing with the extreme value solution (ISO 10993-14 part 4.4) Category: chemical-physical testing medical devices Non-active 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 2026 | Add to cart | |
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Medical devices - degradation products from ceramics (ISO 10993-14) 2 Article Number: 2010389 |
May 2027 | Add to cart | ||
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Medical devices - detection of endotoxins (Ph. Eur. 2.6.14) Parameters (qualitative): endotoxins [positive or negative] 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 Sterility and contamination testing Accreditation: This proficiency test is not included in the scope of the accreditation. |
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October 2026 | Add to cart | |
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Medical devices - detection of endotoxins (Ph. Eur. 2.6.14) Parameters (qualitative): endotoxins [positive or negative] Article Number: 2011291 |
September 2027 | Add to cart | ||
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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 Sterility and contamination testing 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 2026 | Add to cart | |
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Medical devices - ethylene oxide residues (ISO 10993-7) 1 Article Number: 2010375 |
September 2027 | Add to cart | ||
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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 Sterility and contamination testing 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 2026 | Add to cart | |
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Medical devices - ethylene oxide residues (ISO 10993-7) 2 Article Number: 2010377 |
September 2027 | Add to cart | ||
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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 Non-active medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. |
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August 2026 | Add to cart | |
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Medical devices - extractables & leachables Parameters (qualitative): identification of various extractables & leachables Article Number: 2011169 |
August 2027 | Add to cart | ||
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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 Non-active medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. |
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February 2026 | Add to cart | |
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Medical devices - extraction of elements (ISO 10993-12) Article Number: 2011159 |
September 2026 | Add to cart | ||
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Medical devices - extraction of elements (ISO 10993-12) Article Number: 2011159 |
September 2027 | Add to cart | ||
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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 Non-active 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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June 2026 | Add to cart | |
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Medical devices - extraction of metals (ISO 10993-12) Article Number: 2010379 |
June 2027 | Add to cart | ||
Under certain circumstances, this parameter may not be available in the proficiency test.
