Validations & Biocompatibility
Our analytical procedures are all validated. While others are studied and validated test methods to be replaced by those specific protocols that the client has established for your product.
Specific Protocol for each product
Validation of all kinds of products.
Biocompatibility
Tests necessary to ensure the biocompatibility of medical devices that come into contact with blood or tissues according to the UNE-EN ISO 10993.
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Validations & Biocompatibility CatalogueProtocol for environmental control facilities
Protocol for microbiological suitability following the harmonized method
Protocol for the determination…
… TAMC
… TYMC
… E. Coli
… Salmonella
… Pseudomonas
… Gram-Bilis
… Aureus
… Candida
… Other
Protocol with special development
Protocol for the Sterility test
Protocol for LAL analysis
Protocol for the Sterilisation process
Protocol for the Bioburden test
Biocompatibility
Do you miss something from our catalogue? Do not hesitate to contact us.