Identification and quantification of degradation products from polymer-based Medical Devices in accordance with the ISO 10993-13 standard
Your needs : to study degradation products from your polymer-based medical devices in accordance with the ISO 10993-13 standard
The ISO 10993-13 standard is part of the ISO 10993 set implemented for the assessment of the biocompatibility of medical devices. These biocompatibility tests are conducted to verify the aptitude of materials to carry out a given function without having undesired side effects.
The ISO 10993-13 standard specifies the relevant regulations surrounding the identification and quantification of degradation products from polymer-based Medical Devices.
Degradation products analyzed following the ISO 10993-13 may be the result of chemical alteration.
Are you looking to cooperate with a reliable and reactive laboratory for assistance in analyzing your medical devices in accordance with the ISO 10993-13 standard ? Feel free to contact us !
Our solution : to assist Medical Device producers in testing the biocompatibility in accordance with the ISO 10993-13 standard for the identification and quantification of degradation products
For over 10 years, FILAB laboratory have been developing a diverse analytical skillset applied to chemical analysis and material characterization. FILAB laboratory is equipped with a cutting-edge analytical fleet spread over 2100m² of laboratory space to be able to provide Medical Device producers with services fulfilling their criteria in terms of product compliance relating to the ISO 10993-13 standard.
Whatever your biomaterial, you can call upon an expert laboratory for the chemical characterization of your materials and the assessment of the biocompatibility of your Medical Devices :
our expertise
Chemical characterization of materials in accordance with the ISO 100993-18 standard
Characterization of Medical Devices containing nanomaterials in accordance with the ISO 10993-22 standard
Sample preparation in accordance with the ISO 10993-12 standard
Identification and quantification of degradation products from polymer-based medical devices in accordance with the ISO 10993-13 and ISO 10993-14 standards
FILAB is also able to provide the following services :
Our services
Biocompatibility testing in accordance with the ISO 10993 set (ISO 10993-18 / ISO 10993-12 / ISO 10993-14 / ISO 10993-15 / ISO 10993-19 / ISO 10993-22)
Problem solving : non-compliance, ruptures, adhesive problems, corrosion…
R&D support : custom chemical analysis, material characterization, surface characterization, analytical development
Procedure validation : cleaning (ISO 19227), surface treatment
The fact that we work on a human scale, our continuous investments and our extensive knowledge of the field of Medical Devices all ensure the reliability of our results, a quick turnaround for requests and tailored support suited to your needs.
For more information about or analytical services for your Medical Devices in accordance with the ISO 10993-13 standard, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05.
David Williams, a well-known expert in the field of biomaterials, has proposed a classification scheme for biocompatibility based on three subgroups of applications. These subgroups are:
- Implantable materials: These are materials that are intended to be implanted within the body, such as orthopedic implants, pacemakers, and stents. Biocompatibility for these materials is critical, as they will be in contact with living tissue for extended periods of time.
- External communicating devices: These are devices that are used externally to communicate with the body, such as insulin pumps or electrodes used for neurological monitoring. These devices do not typically come into direct contact with living tissue, but they must still be biocompatible to avoid adverse reactions.
- Materials used in contact with blood: These are materials that come into contact with blood, such as catheters, vascular grafts, and dialysis membranes. Biocompatibility for these materials is important to ensure that they do not cause clotting or other adverse reactions in the bloodstream.
Overall, Williams' classification scheme recognizes the importance of biocompatibility in different application areas and highlights the need for specific testing protocols and standards for each subgroup. By understanding the specific requirements for biocompatibility in different applications, researchers and manufacturers can develop materials and devices that are safe and effective for their intended use.
Using biocompatible materials and conducting rigorous biocompatibility testing helps to minimize the risks associated with medical devices. It ensures that devices are suitable for their intended use, reducing the likelihood of adverse reactions and complications for patients. Biocompatibility testing provides valuable data and evidence that allows manufacturers to make informed decisions regarding the materials used in their devices and helps regulatory authorities assess the safety and effectiveness of these products before they are made available to the public.
Incorporating biocompatible materials and conducting thorough biocompatibility testing, such as those outlined by ISO 10993 testing lab, is vital to ensure the safety and efficacy of medical devices. These practices play a crucial role in safeguarding patient well-being and enhancing the overall quality of healthcare.
Choosing an ISO 10993 certified testing lab for medical device analysis is important for several reasons:
- Compliance with regulatory requirements: Regulatory bodies such as the FDA require that medical devices undergo biocompatibility testing according to ISO 10993 standards. Choosing a certified testing lab ensures that your tests are performed according to established guidelines and that your data will be accepted by regulators.
- Expertise and experience: Certified testing labs have the expertise and experience necessary to perform biocompatibility testing accurately and efficiently. They are knowledgeable about the latest testing methods and technologies, and they can provide guidance on test selection and interpretation of results.
- Consistent quality: Certified testing labs adhere to rigorous quality management systems, ensuring that their testing processes and procedures are standardized and consistent. This minimizes the risk of errors or deviations in testing and ensures that your results are reliable and reproducible.
- Access to specialized equipment and facilities: Biocompatibility testing often requires specialized equipment and facilities, such as cleanrooms or analytical instruments. Certified testing labs have access to these resources, which may not be available in-house or at non-certified labs.
- Cost-effectiveness: Working with a certified testing lab can be cost-effective in the long run. Certified labs may offer bundled testing packages or discounts for repeat testing, and they may be able to provide additional services beyond biocompatibility testing.
