Testing per ISO 10993-5:2009.
Sample Amount:
- 1 complete device, 30cm² (if >.5mm thickness);
- 1 complete device, 60cm² (if <.5mm thickness);
- 1 complete device, 2 grams (for powders/absorbable material only)
Estimated Turn-Around Time: 3 Weeks
Products specifications
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Subcontracted
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Yes |
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Standards
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ISO 10993-5:2009 |
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Endpoint
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Cytotoxicity |
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Turnaround
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2-3 weeks |
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Test system
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In vitro — L-929 mouse fibroblast culture |
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Method
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MEM Elution |
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Extraction
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1 extract at 10 mL per extract. Extraction ratio per ISO 10993-12: 6 cm2/mL for material under 0.5 mm thick, 3 cm2/mL at 0.5 mm or thicker, or 0.1-0.2 g/mL where surface area is indeterminate. |
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Acceptance criteria
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Per ISO 10993-5, the extract is non-cytotoxic if the reactivity grade is 2 (mild) or less; a grade greater than 2, or a reduction of cell viability below 70% in the quantitative (MTT) assay, indicates a cytotoxic effect. |
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Deliverable
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GLP-compliant final report with raw data, issued in Groenakker’s report template or in your document template on request at no extra cost, under Groenakker’s ISO 13485:2016 certified quality system. |
