Name Planned shipping method Start Date  
Medical devices - detection of endotoxins (Ph. Eur. 2.6.14)
Parameters (qualitative): endotoxins
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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping October 2025 Add to cart
Medical devices - detection of endotoxins (Ph. Eur. 2.6.14)
Parameters (qualitative): endotoxins
Article Number: 2011291
October 2026 Add to cart
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 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 September 2025 Add to cart
Medical devices - ethylene oxide residues (ISO 10993-7) 1
Article Number: 2010375
September 2026 Add to cart
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 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 September 2025 Add to cart
Medical devices - ethylene oxide residues (ISO 10993-7) 2
Article Number: 2010377
September 2026 Add to cart
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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New parameter selection
Refrigerated shipping August 2025 Add to cart
Medical devices - extractables & leachables
Parameters (qualitative): identification of various extractables & leachables
Article Number: 2011169
August 2026 Add to cart
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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
Refrigerated shipping September 2025 Add to cart
Medical devices - extraction of elements (ISO 10993-12)
Article Number: 2011159
September 2026 Add to cart
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 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.
Refrigerated shipping May 2025 Add to cart
Medical devices - extraction of metals (ISO 10993-12)
Article Number: 2010379
June 2026 Add to cart
Medical devices - gravim. determination extractables
Parameters (quantitative): extractables (n-hexane) [mg/dm²], extractables (iso-propanol) [mg/dm²]
Article Number: 2011168
Description: If you are interested in testing aqueous simulants, e.g. ethanol 10% or dist. Water, please have a look at our proficiency tests for global migration in the field of consumer goods.
Category: chemical-physical testing medical devices medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
Shipping at room temperature June 2025 Add to cart
Medical devices - gravim. determination extractables
Article Number: 2011168
July 2026 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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping September 2025 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 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 medical devices
Accreditation: This proficiency test is not included in the scope of the accreditation.
New proficiency testing
Frozen shipping October 2025 Add to cart
Medical devices - in vitro skin irritation (ISO 10993-23)
Parameters (qualitative): skin irritation
Article Number: 2011286
October 2026 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 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
1 Parameter mit dieser Kennzeichnung sind abhangig von der Teilnehmerzahl und/oder der Materialauswahl.
Unter Umständen kann es vorkommen, dass dieser Parameter im Ringversuch nicht zur Verfügung steht.