Currently set filters:

  • New Proficiency tests
Name Planned shipping method Start Date  
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.
New proficiency testing
Frozen shipping October 2026 Add to cart
Medical devices - detection of endotoxins (Ph. Eur. 2.6.14)
Parameters (qualitative): endotoxins [positive or negative]
Article Number: 2011291
September 2027 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 In vitro procedure
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping February 2026 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 eye irritation (OECD492b)
Parameters (qualitative): in vitro eye irritation
Article Number: 2011290
September 2027 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 In vitro procedure
Accreditation: This proficiency test is not included in the scope of the accreditation.
Unfortunately, no further booking is possible this year.
New proficiency testing
Frozen shipping October 2025
Medical devices - in vitro skin irritation (ISO 10993-23)
Parameters (qualitative): in-vitro skin irritation - polar [-], in-vitro skin irritation - nonpolar [-]
Article Number: 2011286
October 2026 Add to cart
Medical devices - in vitro skin irritation (ISO 10993-23)
Parameters (qualitative): in-vitro skin irritation - polar [-], in-vitro skin irritation - nonpolar [-]
Article Number: 2011286
September 2027 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 In vitro procedure
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 - 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 442D,KeratinoSens)
Parameters (qualitative): skin sensitisation
Article Number: 2011288
December 2027 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 In vitro procedure
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 - in vitro skin sensitisation (OECD 442E, h-CLAT)
Parameters (qualitative): skin sensitisation, CD86, CD54
Article Number: 2011289
December 2026 Add to cart
Medical devices - in vitro skin sensitisation (OECD 442E, h-CLAT)
Parameters (qualitative): skin sensitisation, CD86, CD54
Article Number: 2011289
December 2027 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 In vitro procedure
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 - pyrogenic monocyte activation test (Ph. EP 2.6.30)
Parameters (qualitative): monocyte activation, IL-6
Article Number: 2011287
November 2027 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 Sterility and contamination testing
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping November 2026 Add to cart
Medical devices - TOC und THC
Article Number: 2011276
November 2027 Add to cart
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 August 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.