Medical Device Testing Guide - Toxikon Corporation

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ACUTE SYSTEMIC TOXICITY TESTS—MHLW (Cont.) Rev. May 2010 ME01-1 Japanese MHLW Rabbit Pyrogen Test-Sample needed: 600 cm² 0.5 mm thick, 300 cm² 0.5 mm thick, or 20 g The test involves measuring the rise in temperature of three albino rabbits following the intravenous injection of a test material or its extract through the marginal ear veins of rabbits. Body temperatures are recorded three times at 1-hour intervals subsequent to injection. If there is no rise of temperature of 0.6°C or more above baseline, the test material meets the requirements for the absence of pyrogens. Approximate turnaround time is three to four weeks. GENOTOXICITY TEST—MHLW MG01-1 MG02-1 PURPOSE: The genetic toxicology testing is conducted to evaluate the potential of the test article to induce mutations or chromosome damage using a battery of tests in bacterial, mammalian cells in vitro, and in vivo test systems. This information of is of critical importance because genetic damage can cause an increase in the incidence of heritable diseases and cancer in human populations. Physical or chemical agents that induce adverse effects by interacting with genetic material and alter their structure/function are considered "genotoxic‖. Ames Reverse Mutation Assay-Sample needed: 120 cm² 0.5 mm thick, 60 cm² 0.5 mm thick, or 4 g The Ames Assay is conducted to evaluate the potential of a test article to induce reverse mutations in histidine and tryptophan genes in S. typhimurium and E. coli. The test article is extracted in methanol and acetone separately and the extraction rate determined. Depending on the extraction rate per MHLW note IRYOUKIKISHINSHA 37, 2005, the test article may be extracted in Dimethyl Sulfoxide (DMSO). The assay is conducted with four strains of S. typhimurium and one strain of E. coli in the presence and absence of an exogenous mammalian activation system using plate incorporation method of exposure. Evaluation is based on whether there is a significant (p
CYTOTOXICITY TESTS—USP Rev. May 2010 UA01-1 UA02-1 PURPOSE: Cytotoxicity in-vitro screening assays are used to assess – in a fast and sensitive way – the biocompatibility of the test material (extract) when in contact with a specific cell culture. MEM Elution-Sample needed: 120 cm² 0.5 mm thick, 60 cm² 0.5 mm thick, or 4 g The ―in-vitro‖ biological reactivity of the L929 mouse fibroblast cell culture is determined in response to an extract of the test material. The cells are allowed to grow to sub-confluency in tissue culture plates. An extract of the test material is prepared in Minimum Essential Media (MEM), which is transferred onto the cell layer in duplicate. The plates are incubated for fortyeight hours at 37°C in a 5% CO 2 incubator, and scored for reactivity at twenty-four and forty-eight hours on a scale from Grade 0 (no reactivity) to Grade 4 (severe reactivity). The test item is considered non-cytotoxic if none of the cultures exposed to the test item shows greater than mild reactivity (Grade 2). Approximate turnaround time is two to three weeks. Agar Diffusion-Sample needed: 3 cm 2 , 1 g, or 1mL This assay determines the biological reactivity of the L929, a mammalian monolayer cell culture in response to a test material. The test is designed for a variety of solid and liquid test materials. The cells are allowed to grow to approximately 80% confluency in cell culture dishes and then overlaid with an agarose layer. The test material is placed over the agar layer, which protects the cells from mechanical damage while allowing the diffusion of leachables from the test material onto the cell layer. The plates are incubated for forty-eight hours at 37°C in a 5% CO 2 incubator and scored for reactivity at twenty-four and fortyeight hours on a scale from Grade 0 (no reactivity) to Grade 4 (severe reactivity). The test item is considered non-cytotoxic if none of the cultures exposed to the test item shows greater than mild reactivity (Grade 2). Approximate turnaround time is two to three weeks. CLASS TEST FOR PLASTICS—USP PURPOSE: The USP Class tests are designed to determine the biological response of animals to direct and/or indirect contact with a test material. UB01-1 UB01-2 UB01-3 UB01-4 UB01-5 UB01-6 Class Systemic Toxicity Intracutaneous Reactivity Implant NaCl CSO EtOH PEG NaCl CSO EtOH PEG I X ─ ─ X ─ ─ ─ ─ II X ─ X ─ X ─ X ─ ─ III X X X X X ─ X ─ ─ IV X X X ─ X X X ─ X V X X X X X X X X ─ VI X X X X X X X X X *Note: “X” indicates testing required Class I Sample needed: 120 cm 2 < 0.5 mm thick, 60 cm 2 0.5 mm thick, or 4g Approximate turnaround time is four weeks. Class II Sample needed: 240 cm 2 < 0.5 mm thick, 120 cm 2 0.5 mm thick, or 8g Approximate turnaround time is four weeks. Class III Sample needed: 480 cm 2 < 0.5 mm thick, 1200 cm 2 0.5 mm thick, or 16g Approximate turnaround time is four weeks. Class IV Sample needed: Extraction-360 cm 2 < 0.5 mm thick, 180 cm 2 0.5 mm thick, or 12g Implant-12 pieces at 1mm x 1mm x 10 mm Approximate turnaround time is four to five weeks. Class V Sample needed: 480 cm 2 < 0.5 mm thick, 240 cm 2 0.5 mm thick, or 16g Approximate turnaround time is four weeks. Class VI Sample needed: Extraction-480 cm²
Page 1 and 2: Rev. May 2011 Medical Device Testin
Page 3 and 4: Rev. May 2011 About Toxikon For ove
Page 5 and 6: Biocompatibility Testing Matrix Rev
Page 7 and 8: CYTOTOXICITY TESTS—ISO 10993-5 Re
Page 9 and 10: Rev. May 2011 injected intracutaneo
Page 11 and 12: IRRITATION TESTS—ISO 10993-10 (Co
Page 13 and 14: SUBACUTE SYSTEMIC TOXICITY TESTING
Page 15 and 16: SUBCHRONIC SYSTEMIC TOXICITY TESTIN
Page 17 and 18: CHRONIC SYSTEMIC TOXICITY Rev. May
Page 19 and 20: IMPLANTATION TESTS—ISO 10993-6 Re
Page 21 and 22: HEMOCOMPATIBILITY TESTS—ISO 10993
Page 23: CYTOTOXICITY TEST—MHLW Rev. May 2
Page 27 and 28: METALS ANALYSIS Rev. May 2010 UD01-
Page 29 and 30: MATERIAL ANALYSIS (Cont.) Rev. May
Page 31 and 32: BIOBURDEN TESTING Rev. May 2010 Pur
Page 33: RS06-3 BI Strip Population Verifica

Medical Device Testing Guide - Toxikon Corporation

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