Proficiency testing “Medical devices”

Our proficiency test program for medical devices offers laboratories a wide range of proficiency tests. Medical devices include all instruments, substances, objects, machines and software that are used in humans for physical therapeutic and diagnostic purposes. Over 20 proficiency tests from the following disciplines

chemical-physical testing

e.g. for sterilization residues (e.g. ethylene oxide or protein), residues and contaminants (e.g. metals), migration, extraction

Microbiological testimg

e.g. for testing sterilization, in-vitro cytotoxicity, microbial density, identification of microorganisms

are available.

 

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For 2024/25, we have included the following new proficiency tests in the program:

1. Gravimetric determination of extractable substances

Following ISO 10993-12 and ISO 10993-18, the extractable substances are to be determined gravimetrically by total immersion of the test specimens in the simulants n-hexane and iso-propanol. Test conditions: 50°C, 72 h.

2. Extractables & Leachables

Qualitative and quantitative determination: In accordance with ISO 10993-18, a finished extract should first be examined qualitatively using a screening method. Positive results can be determined quantitatively. The E&L are typical substances from the fields of UV absorbers, anti-aging agents, plasticizers, slipping agents, fatty acids and ketones. Possible analysis methods: GC-MS and LC-MS.

3. Extraction of elements (ISO 10993-12)

As a supplement to our proficiency test for the extraction of metals, various elements are to be quantitatively analyzed here, e.g. calcium, phosphorus, magnesium, fluorine, manganese, chromium, iodine and selenium. There will be at least 5 elements in the samples.

 

 

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Search your parameters directly in our online store:  Here you can find the Onlineshop

 

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