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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Identification of microorganisms using MALDI-ToF
Parameters (qualitative): identification of microorganism MALDI-ToF Article Number: 2010657 Category: immunological, molecular biological and microbiological testing medical devices sterility and contamination testing Accreditation: This proficiency test is within the scope of the A2LA accreditation. risk group 1 |
Frozen shipping
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November 2026 | Add to cart | |
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Identification of microorganisms using MALDI-ToF
Article Number: 2010657 |
November 2027 | Add to cart | ||
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Identification of microorganisms using MALDI-ToF
Article Number: 2010657 |
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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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. |
Frozen shipping
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September 2027 | Add to cart | |
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Medical devices - detection of endotoxins (Ph. Eur. 2.6.14)
Article Number: 2011291 |
September 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 | |
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.