Proficiency testing catalogue: medical devices
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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 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. |
 Frozen shipping
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August 2027 | Add to cart | |
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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 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. |
Frozen shipping
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August 2027 | Add to cart | |
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Medical devices - protein residues
Parameters (quantitative): protein [µg] Article Number: 2010961 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. Suitable laboratory equipment is required for participation in the proficiency testing schemes. Is currently underway. Can still be booked. |
Frozen shipping
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August 2026 | Add to cart | |
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Medical devices - protein residues
Article Number: 2010961 |
September 2027 | Add to cart | ||
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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 In vitro procedure Accreditation: This proficiency test is not included in the scope of the accreditation. |
Frozen shipping
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November 2026 | Add to cart | |
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Medical devices - pyrogenic monocyte activation test (Ph. EP 2.6.30)
Parameters (qualitative): monocyte activation, IL-6 Article Number: 2011287 |
November 2027 | Add to cart | ||
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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 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. |
 Shipping at room temperature
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July 2027 | Add to cart | |
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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 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. |
Frozen shipping
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November 2026 | Add to cart | |
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Medical devices - quan. characterization (ISO 10993-18) - Formaldehyde
Article Number: 2010385 |
July 2027 | Add to cart | ||
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Medical devices - quan. characterization (ISO 10993-18) - XRF
Parameters (quantitative): determination of the elements using XRF [%] Article Number: 2010383 Description: semi-quantitative identification of the material surface 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. |
Shipping at room temperature
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July 2027 | Add to cart | |
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Medical devices - TOC und THC
Parameters (quantitative): total organic carbon (TOC) [µg], total hydrocarbons (THC) [µg] Article Number: 2011276 Description: Possible performance of the test e.g. with ISO 19227:2018. The interlaboratory test is used to determine the water-soluble total organic carbon (TOC) and the solvent-soluble hydrocarbons (Total HydroCarbon, THC). Category: chemical-physical testing medical devices Sterility and contamination testing Accreditation: This proficiency test is not included in the scope of the accreditation. |
Frozen shipping
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November 2026 | Add to cart | |
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Medical devices - TOC und THC
Article Number: 2011276 |
November 2027 | Add to cart | ||
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Medical devices - VOC
Parameters (quantitative): VVOC [mg/kg], VOC [mg/kg], SVOC [mg/kg] Article Number: 2011368 Category: chemical-physical testing medical devices Non-active medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. New proficiency testing |
Frozen shipping
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August 2027 | Add to cart | |
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Microbiological analysis of dialysis water 1
Parameters (quantitative): Aerobic total count 36 °C (plate technique) [cfu/ml], Aerobic total count 20 °C (plate technique) [cfu/ml], Aerobic total count 36 °C (membrane filtration) [cfu/10 ml], Aerobic total count 20 °C /membrane filtration) [cfu/10 ml] 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 Water in medical care Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 |
Frozen shipping
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November 2026 | Add to cart | |
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Microbiological analysis of dialysis water 1
Article Number: 2011296 |
July 2027 | Add to cart | ||
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Microbiological analysis of dialysis water 2
Parameters (quantitative): Ps. aeruginosa Article Number: 2011297 Description: Proficiency test series for testing water for haemodialysis and related therapies for microbiological requirements. This part deals with the enumeration of Pseudomonas aeruginosa.Possible methods for participation are e.g. ISO 16266, mineral/table water regulation and drinking water regulation. Category: immunological, molecular biological and microbiological testing medical devices Water in medical care Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 2 |
Frozen shipping
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July 2027 | Add to cart | |
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Microbiological analysis of dialysis water 3
Parameters (quantitative): E.coli, Coliforms Article Number: 2011298 Description: Proficiency test series for testing water for haemodialysis and related therapies for microbiological requirements. This part deals with the enumeration of E. coli and coliform bacteria. Possible methods for participation are e.g. ISO 9308, mineral/table water regulation and drinking water regulation. Category: immunological, molecular biological and microbiological testing medical devices Water in medical care Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 |
Frozen shipping
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April 2027 | Add to cart | |
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Microbiological analysis of endoscopes
Parameters (qualitative): identification of germs Parameters (quantitative): aerobic total count [cfu/endoscope channel] Article Number: 2010567 Description: enumeration and identification of microorganisms; hospital hygiene 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 |
Frozen shipping
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October 2026 | Add to cart | |
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Microbiological analysis of endoscopes
Parameters (qualitative): identification of germs Article Number: 2010567 |
October 2027 | Add to cart | ||
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Microbiological analysis of water from dental units 1
Parameters (quantitative): aerobic total count 36°C [cfu/ml] Article Number: 2011293 Description: Proficiency test series on water quality in dental units. This part deals with the counting of viable microorganisms (total microbial count). Possible methods for participation are e.g. ISO 6222, mineral/table water regulation and drinking water regulation. Category: immunological, molecular biological and microbiological testing medical devices Water in medical care Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 |
Frozen shipping
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July 2027 | Add to cart | |
1
Parameters with this label depend on the number of participants and/or the choice of materials.
Under certain circumstances, this parameter may not be available in the proficiency test.
Under certain circumstances, this parameter may not be available in the proficiency test.