Proficiency testing catalogue: medical devices
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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 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 2028 | Add to cart | |
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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 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 - ethylene oxide residues (ISO 10993-7) 2
Article Number: 2010377 |
September 2028 | Add to cart | ||
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Medical devices - extractable PFAS
Parameters (quantitative): total perfluorohexane sulfonic acid (CAS 355-46-4) [µg/kg], total perfluorooctanesulfonic acid (CAS 1763-23-1) [µg/kg], total perfluorohexanoic acid (CAS 307-24-4) [µg/kg], total perfluorooctanoic acid (CAS 335-67-1) [µg/kg], total perfluorononanoic acid (CAS 375-95-1) [µg/kg], total perfluorodecanoic acid (CAS 335-76-2) [µg/kg], total perfluorundecanoic acid (CAS 2058-94-8) [µg/kg], total perfluorododecanoic acid (CAS 307-55-1) [µg/kg], total perfluorotridecanoic acid (CAS 72629-94-8) [µg/kg], total perfluorotetradecanoic acid (CAS 376-06-7) [µg/kg], 6:2 FTOH (CAS 647-42-7) [µg/kg], 8:2 FTOH (CAS 678-39-7) [µg/kg], 10:2 FTOH (CAS 865-86-1) [µg/kg], 12:2 FTOH (CAS 39239-77-5) [µg/kg], 6:2 FTA (CAS 17527-29-6) [µg/kg], 8:2 FTA (CAS 27905-45-9) [µg/kg], 10:2 FTA (CAS 17741-60-5) [µg/kg], 6:2 FTMA (CAS 2144-53-8) [µg/kg], 8:2 FTMA (CAS 1996-88-9) [µg/kg] Article Number: 2011524 Description: Possible testing e.g. by ISO 10993-18 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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September 2027 | Add to cart | |
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Medical devices - extractable PFAS
Article Number: 2011524 |
September 2028 | Add to cart | ||
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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 non-active medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. |
 Refrigerated shipping
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August 2027 | Add to cart | |
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Medical devices - extractables & leachables
Article Number: 2011169 |
August 2028 | Add to cart | ||
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Medical devices - extraction of elements (ISO 10993-12)
Parameters (quantitative): calcium (Ca) [µg/l], phosphorus (P) [µg/l], magnesium (Mg) [µg/l], fluorine (F) [µg/l], manganese (Mn) [µg/l], chromium (Cr) [µg/l], Iodine (I) [µg/l], selenium (Se) [µg/l] Article Number: 2011159 Category: chemical-physical testing medical devices non-active medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. |
 Shipping at room temperature
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September 2027 | Add to cart | |
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Medical devices - extraction of elements (ISO 10993-12)
Article Number: 2011159 |
September 2028 | Add to cart | ||
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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 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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June 2027 | Add to cart | |
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Medical devices - extraction of metals (ISO 10993-12)
Article Number: 2010379 |
June 2028 | Add to cart | ||
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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 non-active medical devices Accreditation: This proficiency test is not included in the scope of the accreditation. |
Shipping at room temperature
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July 2027 | Add to cart | |
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Medical devices - gravim. determination extractables
Article Number: 2011168 |
July 2028 | Add to cart | ||
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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. |
Frozen shipping
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September 2027 | Add to cart | |
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Medical devices - in vitro eye irritation (OECD492b)
Article Number: 2011290 |
September 2028 | Add to cart | ||
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Medical devices - in vitro skin irritation (ISO 10993-23)
Parameters (qualitative): in-vitro skin irritation - polar [-], in-vitro skin irritation - nonpolar [-] 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 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. |
Shipping at room temperature
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November 2026 | Add to cart | |
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Medical devices - in vitro skin irritation (ISO 10993-23)
Article Number: 2011286 |
September 2027 | Add to cart | ||
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Medical devices - in vitro skin irritation (ISO 10993-23)
Article Number: 2011286 |
September 2028 | Add to cart | ||
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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. |
Frozen shipping
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June 2027 | Add to cart | |
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Medical devices - in vitro skin sensitisation (OECD 442D,KeratinoSens)
Article Number: 2011288 |
June 2028 | 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.