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

Biocompatibility testing according to ISO 10993 for
Permanent implants
Permanent mucosal membrane contact
Body and blood contact up to 30 days
USP Class VI
Acute Systemic Toxicity
Intracutaneous Reactivity
Muscle Implantation
ISO 10993-5
Lot control
Lot control
ISO 10993-10
Sensitization: Maximization test according to Magnusson and Kligman
ISO 10993-10
Sensitization: Murine local lymph node assay (LLNA)
ISO 10993-10
Irritation: Intracuteneous Reactivity
ISO 10993-11
Acute Systemic Toxicity
ISO 10993-11
Subacute/Subchronic Systemic Toxicity
14 days / 28 days*)
14 days
ISO 10993-3
Genotoxicity: Reverse mutation assay (Ames)
ISO 10993-3
Genotoxicity: Chromosome aberration test
ISO 10993-3
Genotoxicity: Mouse Lymphoma test
ISO 10993-6
Implantation Tests
90 days
Muscle 7 days
Muscle 7 days
Hemocompatibility testing
ISO 10993-12
GC/MS Fingerprint

*) Tested on VESTAKEEP i4 G resin

Further information on VESTAKEEP® PEEK

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