Testing per ISO 10993-10:2021. Saline Solution & Sesame Oil, NF Extracts (Polar & Non-Polar)
Sample Amount:
- 6 complete devices, 234cm² total (if >.5mm thickness);
- 6 complete devices, 468cm² total (if <.5mm thickness);
- 6 complete devices, 15.6 grams (for powders/absorbable material only)
Estimated Turn-Around Time: 10 weeks
Products specifications
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Subcontracted
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Yes |
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Standards
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ISO 10993-10:2021 |
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Endpoint
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Sensitization |
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Turnaround
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8-10 weeks |
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Test system
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In vivo — guinea pig (GPMT, induction + challenge) |
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Method
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GPMT (Guinea Pig Maximization) |
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Extraction
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2 extracts at 39 mL per extract; at least 6 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 10993-10, the material is a non-sensitizer when test-group skin reactions are no greater than the control group; Magnusson-Kligman grades of 1 or more in test animals above the control response indicate a sensitization potential. |
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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. |
