Material
What Are USP Class VI and ISO 10993 Compliant TPE Requirements for Medical Applications?
USP Plastic Class VI and ISO 10993 are not two levels of the same approval. USP <88> describes defined in-vivo biological-reactivity tests for plastics and assigns test classifications under specified extraction and exposure conditions. ISO 10993-1:2025 is a risk-management framework for planning the biological evaluation of a medical device according
October 12, 2026
No Comments