Testing per IOS 10993-11:2017. 0.9% Sodium Chloride Solution & Sesame Oil, NF extracts (Polar & Non-Polar)
Sample Requirements:
- 2 complete devices, 60cm² (>0.5mm thickness);
- 2 complete devices, 120cm² (<0.5mm thickness);
- 2 complete devices, 4 grams (powders/absorbable material only)
Estimated Turnaround Time: 6 Weeks
Products specifications
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Subcontracted
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Yes |
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Standards
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ISO 10993-11:2017 |
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Endpoint
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Acute Systemic Toxicity |
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Turnaround
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6-7 weeks |
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Test system
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In vivo — mouse (or rat), polar and non-polar extracts |
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Method
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Acute Systemic Injection |
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Extraction
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2 extracts at 10 mL per extract; at least 2 discrete dose portions. 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 10993-11, the material passes when test animals show no significantly greater biological reactivity than the controls — no mortality and no significant clinical signs or body-weight effects attributable to the extract — during the observation period. |
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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. |
