VESTAKEEP® PEEK for medical applications

Security is key to the medical industry!


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

 

 

VESTAKEEP®

Implant-Grade

VESTAKEEP®

Dental-Grade

VESTAKEEP®

Care-Grade

 

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

Cytotoxicity

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