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Biocompatibility Process of Medical Devices at Sia Analysis Laboratories

Many medical devices require biocompatibility testing according to International Organization for Standardization (ISO) standard 10993. Biological studies vary with the type of medical device being tested. However, ISO 10993 specifies parameters for both in vitro and in vivo evaluations. Expanding its scope in biocompatibility testing to meet in vitro, in vivo biocompatibility, and regulatory standards, Sia Analysis streamlines your medical device testing program and enables you to achieve results in GLP terms.

The variety of formats and materials from which medical devices are developed can make it difficult to design tests that adequately evaluate their safety and efficacy. cIt ranges from polymers, metals, ceramics, and biodegradable and novel materials to solid and porous structures, creams, gels, liquids, fabrics, coatings, and surface treatments. Whether you require testing raw plastic materials or a finished device; Our experts are accredited to provide the most accurate results in line with the demands, utilizing our comprehensive portfolio of in vitro and in vivo services.

Systemic Toxicity; In vivo systemic tests assess disruption or activation of a system rather than disruption of individual cells or organs. Acute systemic toxicity tests evaluate test product material for systemic toxic effects as a result of a single acute exposure.

Sensitization studies; GLP, ISO 10993-10; Biocompatibility testing in susceptibility for medical devices is used to determine a test material’s allergic or sensitizing capacity to repeated or prolonged exposure. Sensitization is characterized by non-localized delayed reactions independent of dose. These studies can be carried out with two different methods;

  • Local lymph Node Assay (LLNA)
  • Guinea pig maximization test (GPMT)

Skin irritation; GLP, ISO 10993-10, Skin Irritation biocompatibility testing consists of in vivo scans that evaluate the potential of test materials or extract to irritate an exposed part of the body. Standard studies are single exposure assessments. Based on clinical product use, studies may be customized to assess repeated exposures.

  • Topical irritation (skin, buccal cavity, vagina, urethra, rectum)
  • Intracutaneous reactivity: Single or cumulative exposure is provided under the intended clinical use.

Pyrogenicity Studies; GLP, ISO 10993-11; It detects endotoxin on the biomaterial surface and any related pyrogen reaction via endotoxin contamination with a certain known toxin limit. Pyrogenicity and endotoxin testing are important steps that can make all the difference in determining whether your product is approved for release. As part of your process manufacturing support network, different testing methods are available to meet the pyrogen and endotoxin testing needs of your products.

Blood Compatibility; For devices in direct contact with circulating blood (regardless of contact time), biocompatibility testing for hemolysis, complement activation, and thrombogenicity can be performed. Hemocompatibility tests are more commonly used to evaluate the effects of medical devices in contact with blood. Hemolysis determines the degree of erythrocyte (red blood cell) lysis and hemoglobin release caused by medical devices in vitro. Both direct (implantation) and indirect (extract) methods can be conducted for material/surface-mediated hemolysis.

Sia Analysis Laboratories; Within the scope of GLP, Kemalpaşa Campus provides services to many stakeholders in toxicology, biocidal, and biocompatibility analysis groups.

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