Proficiency testing catalogue: medical devices
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Medical devices - in vitro skin sensitisation (OECD 442E, h-CLAT)
Parameters (qualitative): skin sensitisation [-] 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 in vitro procedure Accreditation: This proficiency test is not included in the scope of the accreditation. |
 Frozen shipping
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June 2027 | Add to cart | |
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Medical devices - in vitro skin sensitisation (OECD 442E, h-CLAT)
Article Number: 2011289 |
June 2028 | 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. |
Frozen shipping
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September 2027 | Add to cart | |
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Medical devices - protein residues
Article Number: 2010961 |
September 2028 | 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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February 2027 | Add to cart | |
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Medical devices - pyrogenic monocyte activation test (Ph. EP 2.6.30)
Article Number: 2011287 |
November 2027 | Add to cart | ||
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Medical devices - pyrogenic monocyte activation test (Ph. EP 2.6.30)
Article Number: 2011287 |
November 2028 | 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 - qual. characterization (ISO 10993-18)
Article Number: 2010381 |
July 2028 | 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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October 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) - Formaldehyde
Article Number: 2010385 |
July 2028 | 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 - TOC und THC
Article Number: 2011276 |
November 2028 | Add to cart | ||
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Medical devices - VOC
Parameters (quantitative): benzene (CAS 71-43-2) [mg/kg], toluene (CAS 108-88-3) [mg/kg], ethylbenzene (CAS 100-41-4) [mg/kg], xylene (CAS 1330-20-7) [mg/kg], 1,2-dichloroethane (CAS 107-06-2) [mg/kg], 1,1-dichloroethylene (CAS 75-35-4) [mg/kg], tetrachloroethylene (CAS 127-18-4) [mg/kg], pentachloroethane (CAS 76-01-7) [mg/kg], 1,1,1,2-tetrachloroethane (CAS 630-20-6) [mg/kg], 1,1,2,2-tetrachloroethane (CAS 79-34-5) [mg/kg], 1,1,1-trichloroethane (CAS 71-55-6) [mg/kg], 1,1,2-trichloroethane (CAS 79-00-5) [mg/kg], naphthalene (CAS 91-20-3) [mg/kg], phenol (CAS 108-95-2) [mg/kg], n-hexane (CAS 110-54-3) [mg/kg], 2-ethylhexanoic acid (CAS 149-57-5) [mg/kg], 2-ethoxyethanol (CAS 110-80-5) [mg/kg], 2-methoxyethanol (CAS 109-86-4) [mg/kg], vinyl acetate (CAS 108-05-4) [mg/kg], styrene (CAS 100-42-5) [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. |
Frozen shipping
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August 2027 | Add to cart | |
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Medical devices - VOC
Article Number: 2011368 |
August 2028 | 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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July 2027 | Add to cart | |
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Microbiological analysis of dialysis water 1
Article Number: 2011296 |
July 2028 | 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 | |
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.