Direct contact with degradable compounds released from devices such as medical implants may cause harm to the patient. The compatibility of the device material with biological tissues, cells and body fluids must be assessed according to the ISO 10993 standard.
TÜV SÜD PSB provides a comprehensive range of services such as compliant biological, chemical and physical testing in the evaluation of the biocompatibility and safety of medical devices and biomedical materials. These preclinical studies are carried out under conditions and quality management system in compliance with GLP (Good Laboratory Practices).
Our services
The biocompatibility evaluation of medical devices testing services include:
Biological test
- Cytotoxicity
- Sensitization
- Skin irritation/Intracutaneous reactivity
- Systemic toxicity
- Genetic toxicity
- Implantation
- Haemocompatibility
- Clinical biochemistry
- Histopathology analysis
- Other biocompatibility tests
Chemical evaluation
- Chemical composition and characterisation
- Impurities
- Ethylene oxide residues
- Degradation products from polymeric, ceramic and metallic materials
- Leaching and migration tests
- Leachable protein from medical gloves
- Penetration resistance against chemicals
- Permeation rate of chemicals and therapeutic drugs
- Surface morphology and microstructure
- Delamination
- Corrosion
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Your advantages:
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- Reduce your business risks by meeting regulatory requirements and standards.
- Increase quality and safety of your products and processes.
- Save time and costs as we provide you with a one-stop testing and certification service.
- Leverage on our global accreditations.
- Leverage on our state of the art laboratories with comprehensive testing equipment and professional expertise.
- Increase customer confidence in your product when your product goes through independent testing
- Shorten your time-to-market and increase market access when you meet regulatory requirements and standards.
- Our team is highly experienced and qualified, which adds value to your processes.
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