Testing per ISO 10993-23:2021. Polar (Saline) & Non-Polar (Sesame or Cottonseed Oil) Extractions.
Sample Requirements:
- 2 complete devices, 30cm² (>0.5mm thickness);
- 2 complete devices, 60cm² (<0.5mm thickness);
- 2 complete devices, 2 grams (powders/absorbable material only)
Estimated Turn-Around Time: 7 Weeks
Products specifications
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Subcontracted
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Yes |
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Standards
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ISO 10993-23:2021 |
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Endpoint
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Irritation |
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Turnaround
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7-9 weeks |
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Test system
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In vivo — rabbit intracutaneous reactivity |
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Method
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Intracutaneous Reactivity |
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Extraction
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2 extracts at 5 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 10993-23, the material passes when the difference between the mean test and control reaction scores is 1.0 or less; a greater difference indicates an irritant response. |
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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. |
