Plasticizer Evaluation for Medical PVC
Raw-material selection for medical applications is part of the finished device's safety and performance evaluation. Define service conditions and the destination market at the outset.
Device-specific evaluation
Contact tissue or medium, contact duration and use conditions affect the evaluation plan. Validate biocompatibility, extraction and sterilisation effects on the finished device or a suitable representative sample. A medical-grade designation is not device approval or suitability for every use.
Use documents for their intended purpose
The TDS and SDS provide raw-material information. The device manufacturer must separately assess destination-market requirements and the effect of a material change on the device documentation. State the intended use when requesting current documents for Med-X or alternative materials.
Include in your sample enquiry
- Device type, contact and duration
- Sterilisation method
- Destination market and document requirements
Related products and technical documents
Med-X DOP
Medical-Grade Plasticizer
Technical data ↗Sunfleks DOTP
Phthalate-Free PVC Plasticizer
Technical data ↗Optafleks TOTM
High-Temperature Plasticizer
Technical data ↗Product-family information supports preliminary selection. Confirm grade-specific performance, application suitability and current documents with the technical team.