Intertek is an industry leader in biocompatibility testing for medical devices, delivering comprehensive solutions aligned with ISO standards to ensure safety and compliance, and to accelerate your development process.
In an era marked by advances in healthcare and the growing prevalence of medical technologies, the importance of ensuring the safety and effectiveness of medical devices, including biocompatibility considerations, cannot be overstated. As global life expectancy rises, so does the demand for innovative medical solutions.
At Intertek, we understand the critical role of biocompatibility in the development and approval of medical devices, whether they are implantable, wearable, or come into contact with patients in other ways. Our comprehensive services are designed to support manufacturers in navigating the intricate landscape of biocompatibility testing.
ISO 10993-1:2018: Our commitment to biocompatibility testing aligns with the ISO 10993-1:2018 standard—a key framework for the biological evaluation of medical devices. This standard encompasses a risk management process, categorization of devices based on contact duration and nature, and an assessment of biological safety.
Discover how to streamline your risk assessments, optimize your test strategies, and avoid costly delays with expert insights into ISO 10993-1 requirements with our complimentary white paper download.
Biocompatibility Testing: Before initiating biocompatibility testing, we emphasize a comprehensive risk assessment and the creation of a Biocompatibility Evaluation Plan (BEP). Our experienced assessors guide clients through upfront analyses of materials, manufacturing processes, and their impact on the intended use environment. This proactive approach helps streamline testing and may justify the use of existing data or literature in lieu of extensive testing, all while ensuring compliance with ISO 14971.
Specific Considerations and Classifications: Our expertise extends to addressing specific considerations outlined in ISO 10993-1:2018, such as cytotoxicity, sensitization, irritation, and more. We guide clients through the categorization of medical devices into surface, externally communicating, or implantable classes, tailoring our approach to the unique requirements of each category.
ISO 18562 Series for Gas Pathways: Recognizing that ISO 10993 does not cover gas pathway biocompatibility, we direct clients to the ISO 18562 series for evaluating gas pathways in healthcare applications. This includes addressing risks associated with particulate matter, volatile organic compounds, and leachables.
Extractables and Leachables: We promote the use of extractables and leachables studies and chemical characterisation studies in accordance with ISO 10993-18 in conjunction with toxicological risk assessments to address biological endpoints efficiently. We provide guidance on clinical relevance, extraction mediums, and analytical equipment sensitivity, adhering to state-of-the-art requirements.
Test Requirements for PPE gloves: PPE glove testing ensures compliance with standards like EN 455, ASTM D6319 and ASTM D3578, focusing on physical properties, chemical resistance, and biocompatibility. This guarantees the safety and performance of gloves used in medical procedures and protection against hazardous substances.
Intertek Solutions: Intertek stands as a trusted partner in the journey of medical device development. We ensure a streamlined approach, offering a single point of contact for chemical/non-animal testing, risk assessment, and the management of extractables and leachables studies.
- ISO 18562 - VOC Testing
- Extractables and Leachables Testing
- ISO 10993 Part 18
- Watch our podcast episode on VOC testing for medical devices: "Medical Compliance With Clarissa: Volatile Organic Compounds (VOCs) with Kyle Tanis"
To leverage our expertise and ensure the biocompatibility and safety of your medical devices, contact us at icenter@intertek.com.