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Laboratory biocompatibility tests in accordance with ISO 10993
What is biocompatibility?
Biocompatibility is the ability of materials to perform a given function without having undesirable effects in the biological environment (degradation, interference, etc.) in which the material in question is used. A material must be biocompatible if it is used in the design of medical devices that will be in contact with a biological environment.
The biocompatibility of a material does not necessarily depend on the functional purpose of the medical devices that will include this material. Biocompatibility depends above all on the contact time of the material with biological tissue, but also on the type of contact and its ability to fulfil its function. An example of a biocompatible material is titanium, a metallic material used in medical devices such as implants (bone substitutes, prostheses, etc.), for which FILAB performs analyses in accordance with the ISO 5832-3 standard.
How is the biocompatibility of a material assessed in accordance with ISO 10993?
In an evolving regulatory context, the harmonised standards in the NF EN ISO 10993 series are the current benchmarks for the biological evaluation of medical devices and the biocompatibility of materials.
Where to start?
First step :
Once this stage has been completed, FILAB will help you with the rest!
ISO 10993-19 : Physicochemical, morphological and topographical characterisation of materials
ISO 10993-22 : Caractérisation des nanomatériaux
ISO 10993 standard in detail
ISO 10993 comprises the following parts, presented
under the general title "Biological Evaluation of Medical Devices".
What is the biocompatibility classification scheme?
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.
Why is it important to use biocompatible materials?
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.
Why should you choose an iso 10993 certified testing lab for your analysis?
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.
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
Around this topic
- Study of the porosity of a PAH coating on implants according to ASTM F1854
- Determination of the presence of foreign phases in your powders by XRD
- Determination of sterilization residues by ETO according to ISO 10993-7
- Medical Device characterization in accordance with the ISO 10993-19 standard
- Analysis and characterization services for medical devices in accordance with the ISO 10993-18 standard
- Study of degradation products in your medical devices according to ISO 10993-15
- Medical devices - Calculation of TEA
- Toxicological evaluation of leachable substances according to ISO 10993-17
- Identification and quantification of degradation products according to ISO 10993-9
- FILAB characterizes your prosthetic coatings
- Identification and quantification of degradation products on ceramic medical devices according to ISO 10993-14
- Identification and quantification of degradation products from polymer-based Medical Devices in accordance with the ISO 10993-13 standard
- Verification of the exhaustiveness of an extraction method in accordance with the ISO 19227 and ISO 10993-12 standards.
- Chemical characterization of materials in accordance with ISO 10993-18
- HAP powder characterization
- Laboratory analysis of extractables and leachables (E&Ls)