Proficiency testing catalogue: medical devices
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Detection microb. contamination cell culture - moulds
Parameters (qualitative): moulds qualitative [-] 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 - moulds
Article Number: 2011474 |
November 2028 | Add to cart | ||
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Detection microb. contamination cell culture - Mycobacteria
Parameters (qualitative): 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 - Mycobacteria
Article Number: 2011473 |
November 2028 | Add to cart | ||
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Detection microb. contamination cell culture - Mycoplasma
Parameters (qualitative): Mycoplasm [-] 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 microb. contamination cell culture - Mycoplasma
Article Number: 2011472 |
November 2028 | Add to cart | ||
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Detection of Salmonella spp. in medicinal herbs (Pharm.Eur. 2.6.31)
Parameters (qualitative): Salmonella spp. [-] 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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Detection of Salmonella spp. in medicinal herbs (Pharm.Eur. 2.6.31)
Article Number: 2011457 |
March 2028 | Add to cart | ||
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Genotoxicity - AMES-Test (ISO 10993-3, OECD 471)
Parameters (qualitative): mutagenicity [-] 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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Genotoxicity - AMES-Test (ISO 10993-3, OECD 471)
Article Number: 2011477 |
November 2028 | Add to cart | ||
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Haemocompatibility - interaction with blood (ISO 10993-4, ASTM F756-17)
Parameters (qualitative): in vitro coagulation [-], In vitro platelet activation [-] Parameters (quantitative): Haemolysis [%] 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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Haemocompatibility - interaction with blood (ISO 10993-4, ASTM F756-17)
Article Number: 2011476 |
November 2028 | Add to cart | ||
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Mammalian cell culture - cell counting (ISO 20391)
Parameters (quantitative): cell count [cells/µl] 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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Mammalian cell culture - cell counting (ISO 20391)
Article Number: 2011475 |
November 2028 | Add to cart | ||
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Non-sterile medical devices - A.brasiliensis (Ph.Eur.2.6.12)
Parameters (quantitative): A.brasiliensis [cfu/g] 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 - A.brasiliensis (Ph.Eur.2.6.12)
Article Number: 2011466 |
May 2028 | Add to cart | ||
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Non-sterile medical devices - B.subtilis (Ph.Eur.2.6.12)
Parameters (quantitative): B. subtilis [cfu/g] 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 - B.subtilis (Ph.Eur.2.6.12)
Article Number: 2011464 |
May 2028 | Add to cart | ||
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Non-sterile medical devices - C.albicans (Ph.Eur.2.6.12)
Parameters (quantitative): C.albicans [cfu/g] 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.2.6.12)
Article Number: 2011465 |
May 2028 | Add to cart | ||
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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.