VESTAKEEP® PEEK
Quality and approvals
Evonik has established a product portfolio that is build on the specific quality, process and performance requirements demanded by the medical industry.
Our quality system based on ISO 9001:2008 ensures a consistent, reliable and traceable supply to our customers. Our stock shape production facilities are additionally certified to ISO 13485.
VESTAKEEP® PEEK resins and stock shapes for medical applications are thoroughly tested for biocompatibility and toxicity. For our implant grades, masterfiles are filed with the FDA. We provide full support to our customers with the registration of their devices.
Biocompatibility tests
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VESTAKEEP®Implant-Grade
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VESTAKEEP®Dental-Grade
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VESTAKEEP®Care-Grade
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Biocompatibility testing according to ISO 10993 for
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Permanent implants
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Permanent mucosal membrane contact
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Body and blood contact up to 30 days
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USP Class VI
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Acute Systemic Toxicity
Intracutaneous Reactivity Muscle Implantation |
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•
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•
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ISO 10993-5
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Cytotoxicity
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Lot control
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Lot control
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ISO 10993-10
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Sensitization: Maximization test according to Magnusson and Kligman
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ISO 10993-10
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Sensitization: Murine local lymph node assay (LLNA)
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•
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ISO 10993-10
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Irritation: Intracuteneous Reactivity
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•
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•
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•
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ISO 10993-11
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Acute Systemic Toxicity
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•
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•
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ISO 10993-11
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Subacute/Subchronic Systemic Toxicity
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14 days / 28 days*)
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14 days
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ISO 10993-3
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Genotoxicity: Reverse mutation assay (Ames)
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•
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ISO 10993-3
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Genotoxicity: Chromosome aberration test
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ISO 10993-3
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Genotoxicity: Mouse Lymphoma test
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ISO 10993-6
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Implantation Tests
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90 days
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Muscle 7 days
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Muscle 7 days
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Hemocompatibility testing
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•*)
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ISO 10993-12
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GC/MS Fingerprint
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*) Tested on VESTAKEEP i4 G resin
