Volatile organic compounds (also known as VOCs) are compounds that evaporate rapidly from their liquid or solid state into the atmosphere under normal pressure and temperature conditions. VOCs are of concern due to their low boiling points, extensive use, relatively high toxicity, and a high degree of halogenation.
ISO 10993-18 focus on chemical characterisation of medical device material within a risk management process. Part of this process is the identification, quantification of extractables and leachable compounds using gas chromatography/mass spectrometry (GC/MS) technology.
However, this procedure requires rigorous quality control. Therefore, the GC/MS system must be conditioned and prepared before starting the analysis.
Volatile Organic Compounds (VOCs) are collected by incubation of the device at 150°C in a sealed vessel using Head-Space Trap Technology and analyzed by gas chromatography-mass spectrometry (GC/MS) which will provide a signal and a identification using NIST ( NIST: National Institute of Standards and Technology) database.
👉 Medistri provides its customers with the accurate Volatile organic compounds analysis (VOCs) by GC/MS required to ensure they are meeting the regulation guidelines around & clean-up regulatory requirements for protection of final patients..
ISO 18562, for example, is the standard for evaluating the biocompatibility of of a medical equipment with a breathing gas route. When the gas channel is expected to come into contact with a patient through the respiratory tract, the air released by the device must be tested for hazards such as volatile organic compounds (VOCs) and particulate matter.
Volatile organic compounds analysis (VOCs) by GC/MS for:
✅ The pharmaceutical Industry
✅ The Medical Device Industry
✅ The Industrial & Manufacturing Industries
✅ Scientific Research
✅ R&D
Our laboratory is constantly expanding its range of services and has set up this procedure based on standards methods as EPA for exemple.
🎯 If you would like to know more about our Volatile organic compounds analysis (VOCs) by GC/MS services, visit our website at www.medistri.swiss/en or contact us directly at contact@medistri.swiss.
- The Medistri Team
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