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Validation Item
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Regulatory Standards
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Bacterial endotoxin
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USP 85
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Biological reactivity test – in vitro
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USP 87
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Biological reactivity test – in vivo
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USP 88
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Elastic sealant for injection
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USP 381
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Physicochemical properties of plastics
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USP 661
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Sub-visible particles
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USP 788
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Genotoxicity, carcinogenicity, and reproductive toxicity
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ISO 10993 3
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Selection of tests for interactions with blood – in vitro hemocompatibility
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ISO 10993 4
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In vitro cytotoxicity test
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ISO 10993 5
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Stimulation and sensitivity test – Kligman maximization test
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ISO 10993 10
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Systemic toxicity test
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ISO 10993 11
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Rubber products
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FDA 21 CFR 177.2600
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Sealing and tubing testing of organic silicone elastomers
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EP 3.1.9
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Extractables
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BPOG
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