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For a printer-friendly version, click here. To access our Medical Device catalog of services, click here. Biocompatibility / Safety Testing for Medical Devices For a table that outlines the ISO/FDA test modalities frequently used to study the biological safety and biocompatibility of medical devices, click here. These tests should be conducted on final product or representative samples according to the category of the device (based on anatomic location and duration of contact). AppTec's comprehensive menu of services includes all the tests related to the table’s “Tests for Consideration,” as well as those tests that may be required for Japanese (JMHLW) submissions. For regulatory clearance purposes, most tests should be carried out under controlled laboratory conditions in compliance with Good Laboratory Practices (GLP). AppTec's biocompatibility / safety testing services feature: • Dedicated isolated study suites • Interpretation of histopathology and other toxicology data • Regulatory consultation to optimize study for specific devices AVAILABLE TESTING SERVICES INCLUDE: Cytotoxicity (in vitro) Agarose Overlay (USP, ISO) MEM Elution (USP, ISO) Direct Contact Growth InhibitionExtract Colony Assay (JMHLW) Sensitization (in vivo) Guinea Pig Maximization Guinea Pig Repeated Patch (Buehler) Murine Local Lymph Node Assay (LLNA) Maximization Sensitization Test (JMHLW) Irritation/Intracutaneous Reactivity (in vivo) Intracutaneous (USP, ISO, JMHLW) Primary Skin Irritation (ISO, JMHLW) Ocular Irritation Intraocular Irritation Mucosal Irritation: Oral • Vaginal • Bladder Acute Dermal Limit Systemic (Acute) Toxicity (in vivo) Acute Systemic Toxicity (USP, ISO, JMHLW) Pyrogen–Materials Mediated (USP, ISO, JMHLW) Mouse Safety & Abnormal Toxicity Subacute/Subchronic Toxicity (in vivo) Subacute Toxicity – Intravenous • Intraperitoneal Subchronic Toxicity (JMHLW) Genotoxicity (in vitro and in vivo) In vitro Bacterial Mutagenicity (Ames) In vitro Mouse Lymphoma In vitro Chromosomal Aberration In vivo Mouse Micronucleus Bacterial Reverse Mutation (JMHLW) In vitro Chromosome Aberration (JMHLW) Implantation (in vivo) Intramuscular Implant (USP, ISO, JMHLW) Subcutaneous Implant Intraperitoneal Implant Hemocompatibility (in vitro and in vivo) Hemolysis Test – Extract Method (ASTM or NIH) – Direct Contact Method (ASTM or NIH) – Hemolytic Toxicity (JMHLW) Complement Activation Coagulation Studies Platelet and Leukocyte Counts Intravascular Thrombogenicity Chronic Toxicity Subcutaneous • Intraperitoneal Dermal • Intravenous • Oral Carcinogenicity Clinical Pathology Chemistry – 18 Test Parameters Hematology – 14 Test Parameters Histopathology / Immunochemistry Other Biocompatibility Testing USP Rabbit Pyrogen Test LAL Bacterial Endotoxin Tests for Pyrogenicity USP Safety Test in Mice and Guinea Pigs In vivo Assay for Viral Contaminants Cytotoxicity Screening of Dissolvable Materials USP Class I - VI Part 18 Risk Assessment and Analytical Chemistry Customized assays, complete toxicology and custom implant studies also available.
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