What is ISO 10993-10 Test?
In other words, the ISO 10993-10 standard, the sensitization test, evaluates the possibility that exposure to any material or product over long periods of time may cause a sensitizing effect or allergic reaction in a patient. For sensitization or hypersensitivity reactions, it usually occurs as a result of repeated or prolonged contact with a chemical that will interact with the body´s immunity.
The skin of laboratory animals is used for susceptibility testing, since most of the reactions similar to biomaterials are of the humoral or dermal cell-mediated type other than the ad antigen-antibody type. Dermal sensitization reactions in laboratory animals are marked by redness or swelling. It is made by extractable chemicals in biomaterials and devices that can cause sensitizing reactions. In exceptional cases, an individual can only develop a reaction after repeated exposure to a material or as a result of continuous prolonged contact such as an implant.
What are ISO 10993-10 Test Methods?
Biomaterials and other device materials are tested for the presence of sensitive chemicals using guinea pigs, a species that, as humans, are nearly responsive to dermal sensitizers. Guinea pig sensitization tests require six to eight weeks and therefore take the longest time to complete all acute biocompatibility tests described in the 10993 standards.
The repeat or Buehler test method may expose the shaved backs of guinea pigs directly to the test materials under occlusive dressing for at least six hours. The procedure is repeated three times weekly for three weeks. The test is often referred to as the induction phase. It is primarily used for topical device such as dermal electrodes or surgical gowns and drapes in the repeat patch pattern. Because in such cases, the application method of animal test materials is simulated with clinical use.
In maximization or the Magnuson-Kligman test method, liquid extracts of the test material are prepared in saline and vegetable oil, and separate groups of guinea pigs are repeatedly placed in the two groups of extracts. Guinea pigs are first injected with an extract along with an excipient to enhance an immune response, then a topical application is received. After two weeks of rest or recovery, the animals are covered with a tropical patch containing the extract. The maximum valuation test, which is generally considered more sensitive than the re-patch model, is used with device materials that contact areas other than the skin. Thus, in the use of both a saline extract and an oil extract, extraction is simulated from body fluids and intravenous fluids and other pharmaceutical products that first come into contact with the device and then with the patient.
In both techniques, the area of ??challenge patches is examined for reactions (redness and swelling) not found in negative control animals. In addition, known sensitizing chemicals are used periodically to validate the model and the technician.
What is ISO 10993-10 Biocompatibility Assessment Process?
Biocompatibility assessment process - rely on our expertise in bioassessment
We help classify your medical devices and analyze physical and chemical information in detail to evaluate next steps in a risk analysis in accordance with current ISO 10993-1: 2018. If precise chemical information is not available, we will discuss with you the conduct of chemical characterizations according to current ISO 10993-18:2020.
If you do not have in-house capacity, we ensure that it is done in the laboratories that best suit your needs. We collaborate with external contract partners or your laboratory during the design-testing and reporting stages.
Based on the results, SCC performs a risk assessment using toxicological literature and database data. In most cases, sufficient data is already available and biological tests are not required or a limited number are required.
If further studies are needed for biological evaluation, we prepare the test plan together with the test laboratory. We check all-round compliance with legal and scientific requirements and standards, including ISO 10993 (monitoring).
Upon completion of the studies, we prepare a final report as part of the conformity assessment procedure. The report includes a detailed rationale for waiving unnecessary testing, in addition to a summary, discussion, and evaluation of all results. To summarize the process in general terms;
• Evaluation of physical and chemical information (considering ISO 10993-18)
• Risk assessment in accordance with ISO 10933-1
• Preparation of study design with laboratory if necessary
• Examine the monitoring of biological tests, if necessary
• Preparation of the final report