Proficiency testing catalogue: medical devices
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Detection microb. contamination cell culture - moulds
Article Number: 2011474 Description: Detection of moulds for the purpose of monitoring contamination in cell culture media or cell culture supernatants. Cultural, molecular biological or microscopic methods may be used for detection; see also ISO/TR 4752 Category: immunological, molecular biological and microbiological testing medical devices Cell culture Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 New proficiency testing |
 Frozen shipping
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November 2027 | Add to cart | |
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Detection microb. contamination cell culture - Mycobacteria
Article Number: 2011473 Description: Detection of mycobacteria for the purpose of monitoring contamination in cell culture media or cell culture supernatants, e.g. in accordance with Ph. Eur. 2.6.2. Category: immunological, molecular biological and microbiological testing medical devices Cell culture Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 New proficiency testing |
Frozen shipping
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November 2027 | Add to cart | |
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Detection microb. contamination cell culture - Mycoplasma
Article Number: 2011472 Description: Detection of mycoplasma for the purpose of monitoring contamination in cell culture media or cell culture supernatants, e.g. in accordance with Ph. Eur. 2.6.7. Both culture-based detection methods and molecular biological methods may be used. Category: immunological, molecular biological and microbiological testing medical devices Cell culture Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 New proficiency testing |
Frozen shipping
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November 2027 | Add to cart | |
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Detection of Salmonella spp. in medicinal herbs (Pharm.Eur. 2.6.31)
Article Number: 2011457 Description: Possible methods for participation, e.g: (Pharm.Eur. 2.6.31) Category: immunological, molecular biological and microbiological testing medical devices Herbal medicinal products Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 2 New proficiency testing |
Frozen shipping
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March 2027 | Add to cart | |
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Genotoxicity - AMES-Test (ISO 10993-3, OECD 471)
Article Number: 2011477 Description: Qualitative assessment of mutagenicity. The samples are simulated extracts. The extraction of a medical device is not part of the proficiency test Category: immunological, molecular biological and microbiological testing medical devices Biocompatibility Accreditation: This proficiency test is not included in the scope of the accreditation. New proficiency testing |
 Shipping at room temperature
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November 2027 | Add to cart | |
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Haemocompatibility - interaction with blood (ISO 10993-4, ASTM F756-17)
Article Number: 2011476 Description: Qualitative assessment of a non-implantable product for haemocompatibility. To this end, the product must be assessed with regard to material-induced haemolysis, coagulation (in vitro) and platelet activation (in vitro) Category: immunological, molecular biological and microbiological testing medical devices Biocompatibility Accreditation: This proficiency test is not included in the scope of the accreditation. New proficiency testing |
Shipping at room temperature
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November 2027 | Add to cart | |
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Mammalian cell culture - cell counting (ISO 20391)
Article Number: 2011475 Description: Determination of the total cell count in a suspension of mammalian cells using direct and indirect counting methods; see also ISO 20391-1 Category: immunological, molecular biological and microbiological testing medical devices Cell culture Accreditation: This proficiency test is not included in the scope of the accreditation. risk group 1 New proficiency testing |
Frozen shipping
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November 2027 | Add to cart | |
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Medical devices - extractable PFAS
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 - 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
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August 2027 | Add to cart | |
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Non-sterile medical devices - A.brasiliensis (Ph.Eur.2.6.12)
Article Number: 2011466 Description: Quantitative testing of non-sterile medical devices for the enumeration Aspergillus brasiliensisin accordance with Ph. Eur. 2.6.12, USP 61, or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 1 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - B.subtilis (Ph.Eur.2.6.12)
Article Number: 2011464 Description: Quantitative testing of non-sterile medical devices for the enumeration Bacillus subtilis in accordance with Ph. Eur. 2.6.12, USP 61, or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 1 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - C.albicans (Ph.Eur.2.6.12)
Article Number: 2011465 Description: Quantitative testing of non-sterile medical devices for the enumeration Candida albicans in accordance with Ph. Eur. 2.6.12, USP 61, or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - C.albicans (Ph.Eur.2.6.13)
Article Number: 2011471 Description: Qualitative derection of Candida albicans in non-sterile medical devices in accordance with Ph. Eur. 2.6.13, USP 62 or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - E.coli (Ph.Eur.2.6.13)
Article Number: 2011469 Description: Qualitative derection of E.coli in non-sterile medical devices for in accordance with Ph. Eur. 2.6.13, USP 62 or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - Ps.aeruginosa (Ph.Eur.2.6.12)
Article Number: 2011463 Description: Quantitative testing of non-sterile medical devices for the enumeration Pseudomonas aeruginosa in accordance with Ph. Eur. 2.6.12, USP 61, or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - Ps.aeruginosa (Ph.Eur.2.6.13)
Article Number: 2011468 Description: Qualitative derection of Pseudomonas aeruginosa in non-sterile medical devices in accordance with Ph. Eur. 2.6.13, USP 62 or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - S.aureus (Ph.Eur.2.6.12)
Article Number: 2011511 Description: Quantitative testing of non-sterile medical devices for the enumeration Staphylococcus aureus in accordance with Ph. Eur. 2.6.12, USP 61, or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - S.aureus (Ph.Eur.2.6.13)
Article Number: 2011467 Description: Qualitative derection of Staphylococcus aureus in non-sterile medical devices in accordance with Ph. Eur. 2.6.13, USP 62 or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Non-sterile medical devices - Salmonella spp. (Ph.Eur.2.6.13)
Article Number: 2011470 Description: Qualitative derection of Salmonella spp. in non-sterile medical devices in accordance with Ph. Eur. 2.6.13, USP 62 or other harmonized pharmacopoeias Category: immunological, molecular biological and microbiological testing medical devices Examination of non-sterile medical products Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 2 New proficiency testing |
Frozen shipping
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May 2027 | Add to cart | |
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Spectacle frames - nickel relase
Article Number: 2011523 Description: Possible testing e.g. by EN 16128 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 |
Shipping at room temperature
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September 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.