ISO 18562 and VOC Testing for Medical Devices

Intertek is committed to providing expert biocompatibility testing and evaluation of breathing gas pathways in medical devices, providing in-depth analysis and toxicological risk assessments to meet stringent regulatory standards and safeguard patient health.

ISO 18562 Series: In-depth Standards for Gas Pathways

Because ISO 10993 alone does not sufficiently cover the biocompatibility of gas pathways of medical devices, the ISO 18562 series was developed to define testing requirements relevant to gas pathways. The scope of the ISO 18562 series includes medical devices with indirect contact to the patient by way of air or medical gas flow through the device to the patient. These devices must be evaluated according to ISO 18562 in addition to ISO 10993.

• ISO 18562-1: Focuses on the evaluation and testing within a risk management process, emphasizing the importance of integrating biocompatibility assessments with overall risk management for medical devices.
• ISO 18562-2: Addresses the tests for emissions of particulate matter, ensuring that devices do not release harmful levels of particles into the breathing gas pathway, which could impact patient health.
• ISO 18562-3: Specifies the testing for emissions of volatile organic compounds (VOCs), critical for identifying and quantifying any potentially harmful VOCs that could be inhaled by patients.
• ISO 18562-4: Concentrates on tests for leachables in condensate, ensuring that any substances that could leach into the patient's airway from condensation are identified and assessed for safety.

Expert Testing and Toxicological Risk Assessment

Our state-of-the-art ISO 17025 accredited laboratories provide exhaustive testing services, including detailed VOC and leachable evaluations using cutting-edge methodologies including the latest HRAM (high resolution accurate mass) based LC-MS and HRAM GC-MS, particulate matter analysis by gravimetric measurement or laser photometry, and inorganic gas measurements. Our toxicology experts meticulously review all test data to determine patient exposure levels and evaluate potential toxicological risks, guaranteeing that your device meets the highest safety benchmarks.

Intertek’s Pharma TRACE team performs all the back-end toxicological risk assessments on the analytical data that are generated. This enables us to offer a complete package of testing, analysis, and tox assessment.

Tailored Support for Your Device

Our VOC testing approach includes targeted testing to pinpoint specific VOC sources in device materials, customizing testing protocols to your device's specific needs. For leachable testing in condensate Intertek uses the latest and most advanced sample preparation methods such as stir bar sorptive extraction or solid phase microextraction listed in ISO 18652-4 standard. We guide you through each phase of the biological evaluation plan, from the initial testing stages to the final toxicological risk assessment, ensuring full compliance with ISO 18562 alongside ISO 10993 standards.

Global Reach, Local Expertise

Intertek's global laboratory network offers unparalleled support for chemical evaluation according to the ISO 18562 series and ISO 10993-17 and -18 for biocompatibility and VOC testing. Our experts are adept at designing and executing test plans, ensuring your medical devices are not only safe but also fully compliant with international safety standards. All chemical testing and data analysis is performed in-house, allowing for rapid data evaluation and follow-up investigations into observed compounds of concern without the need for costly and tedious subcontracting.

Choose Intertek for Expert Biocompatibility and VOC Testing

Rely on Intertek's extensive regulatory, analytical, and toxicological expertise to navigate the intricate process of biocompatibility testing. Trust us to provide accurate, scientifically robust testing and evaluation for your respiratory medical devices, ensuring they are safe for patient use and meet all regulatory requirements. Our customer-focused approach gives you direct access to the chemists and toxicologists managing your project from the initial planning phase, through data analysis and interpretation, to any follow-up studies that you may desire. When testing reveals VOC emissions that pose a risk to the patient, our chemists can work with you to develop component-level test plans to determine the source and help you improve your product’s safety.

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