Chemical characterization of medical devices

Chemical characterization of medical devices by ISO 10993-18 is a key step of the biocompatibility evaluation and must almost always be performed before bringing new devices to market. We offer accredited and GLP-certified chemical characterization services at competitive prices.
Chemical analysis
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Extraction testing

ISO 10993-18 testing procedure

The ISO 10993-18 standard outlines the testing procedure for identifying the chemical constituents of medical devices and measuring the extent to which they are released during clinical use. The purpose is to ensure that patients are not exposed to harmful levels of extractable or leachable chemicals.

During testing, chemicals are extracted from the device or component and subsequently analyzed using different chemical analysis methods to identify different constituents. Applicable methods may include HS-GC-MS (volatile organic compounds), GC-MS (semi-volatile organic compounds), LC-MS (non-volatile organic compounds), and ICP-MS (inorganic elements).

Elina Tenhunen
Questions?

Medical device testing expert Elina Tenhunen is happy to help.

Large service selection, commitment to quality, and exceptional customer service

Our global network of partner laboratories allows us to offer an exceptionally large variety of medical device tests in one place. In addition to ISO 10993-18 chemical characterization services, our test selection includes other ISO 10993 tests from cytotoxicity, skin sensitization, and hemocompatibility to acute, subchronic, and systemic toxicity. Other services, such as medical device packaging validation, bacterial endotoxin testing, bioburden and sterility evaluations, and mechanical testing are also available.

The medical device tests we offer are performed in ISO 17025-accredited and GLP-certified laboratories. This ensures that you get the test results in a format that can be submitted to officials for FDA premarket submissions and EU MDR conformity assessments.

You will also get all the necessary support from our highly qualified testing experts throughout the process. With their help, you can reduce the time spent on contemplating which tests to perform and with which methods, thus freeing time for other important projects.

Why choose Measurlabs?

Widest range of testing methods – get all your tests done in the same place.

Best laboratories – for every test, we have sourced the best lab for that particular method, which means that you get the most accurate results and the best price.

Personal service – get help from method experts if you are unsure about standards, your testing needs or sample suitability.

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