ISO 10993-13 medical device testing laboratory
Your needs : to study degradation products from your polymer-based medical devices in accordance with the ISO 10993-13 standard
What is ISO 10993-13?
ISO 10993-13 is part of the NF EN ISO 10993 series of standards set up to assess the biocompatibility of medical devices. It specifically concerns the identification and quantification of degradation products of polymeric materials that may migrate into the body on contact with the device.
These biocompatibility tests enable us to assess the degradation of polymeric materials and check their ability to perform a given function without adverse effects.
ISO 10993-13 defines the regulations in force for the identification and quantification of degradation products in medical devices made from polymers. Degradation products analyzed within the scope of ISO 10993-13 may be the result of chemical alteration.
Why carry out an ISO 10993-13 analysis?
The purpose of analyzing your medical devices in accordance with ISO 10993-13 is to :
iso 10993-13 testing
Ensuring patient safety by identifying and quantifying substances that may be released from a DM during use
Ensure DM compliance with ISO 10993-13 and obtain marketing authorization
Improve the design of medical devices by choosing safer, higher-performance materials
Are you looking for a reliable, responsive laboratory to help you analyze your medical devices to ISO 10993-13 standards?
Our solutions: supporting you in biocompatibility analysis in accordance with ISO 10993-13
Why choose FILAB for ISO 10993-13 testing?
For over ten years, the FILAB laboratory has been developing a wide range of skills in chemical analysis and materials characterization. With over 5,200m2 of state-of-the-art analytical ressources and a high level of human expertise, FILAB offers medical device manufacturers services that meet their ISO 10993-13 compliance criteria for the identification and quantification of degradation products.
Whatever your biomaterial, call on a laboratory of expertise for the chemical characterization of your materials and the assessment of the biocompatibility of your medical devices:
our expertise
Identification and quantification of degradation products of polymer-based medical devices according to ISO 10993-13 and ISO 10993-14
FILAB can also assist you with the following services:
Our services
Biocompatibility study to ISO 10993 ( -18 / -12 / -13 / -14 / -15 / -19 / -22)
Problem-solving through failure analysis: non-conformity, breakage, adhesion, corrosion, etc.
Support à la R&D : Analyse chimique à façon, caractérisation de matériaux et surface, développement analytique
R&D support: custom chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Our human scale, ongoing investment and knowledge of the medical device sector guarantee our customers reliable results, rapid response to requests and tailor-made support for their iso 10993-13 testing needs.
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.
