Name Planned shipping method Start Date  
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
Frozen shipping 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
Frozen shipping 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 - 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 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 August 2026 Add to cart
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 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 August 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.
Unfortunately, no further booking is possible this year.
Frozen shipping September 2025
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
Frozen shipping March 2026 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
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 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 July 2026 Add to cart
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 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 July 2026 Add to cart
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 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 July 2026 Add to cart
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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping November 2025 Add to cart
Medical devices - TOC und THC
Article Number: 2011276
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
Shipping at room temperature November 2026 Add to cart
Microbiological analysis of dialysis water 1
Parameters (quantitative): Aerobic total count 36 °C, Aerobic total count 22 °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
Frozen shipping October 2025 Add to cart
Microbiological analysis of dialysis water 1
Article Number: 2011296
October 2026 Add to cart
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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
risk group 2
New proficiency testing
Frozen shipping October 2026 Add to cart
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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
risk group 1
New proficiency testing
Frozen shipping October 2026 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.