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
e.g. for sterilization residues (e.g. ethylene oxide or protein), residues and contaminants (e.g. metals), migration, extraction
e.g. for testing sterilization, in-vitro cytotoxicity, microbial density, identification of microorganisms
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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Overview medical devices
- Tests for sterilization - ISO 11737-1
- Tests for in vitro cytotoxicity - ISO 10993-5
- Extraction of metals and elements - ISO 10993-12
- Test methods for medical face masks - EN 14683
- Sterilization residues / ceramic degradation products / mass loss
- Identification of microorganisms
- Qualitative and quantitative characterization - ISO 10993-18