Testing per ISO 10993-11:2017 / USP<151>. 1 extract (0.9% Sodium Chloride Solution).
Sample Requirements:
- 1 complete devices, 270cm² (>0.5mm thickness);
- 1 complete devices, 540cm² (<0.5mm thickness);
- 1 complete devices, 18 grams (powders/absorbable material only)
Estimated Turnaround Time: 8 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 / USP<151> |
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Endpoint
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Material Mediated Pyrogenicity |
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Turnaround
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8-9 weeks |
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Test system
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In vivo — rabbit, intravenous extract |
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Method
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Material-Mediated Rabbit Pyrogen |
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Extraction
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1 extract at 90 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 USP <151>, the initial test uses 3 rabbits and the material passes when no individual rabbit shows a temperature rise of 0.5 °C or more. If any rabbit reaches 0.5 °C or more, the test is repeated with 5 additional rabbits (8 total); the material passes when no more than 3 of the 8 rabbits show an individual rise of 0.5 °C or more AND the sum of the 8 individual maximum temperature rises does not exceed 3.3 °C. (A single rabbit reaching 0.5 °C in the initial test triggers expansion to 8 rabbits, not outright failure.) |
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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. |
