TÜV SÜD — Biocompatibility Testing for Medical Devices: ISO 10993 Guide
Summary
Guidance on ISO 10993 biological evaluation requirements for medical devices, covering testing strategies for cytotoxicity, sensitization, irritation, and systemic toxicity. Explains how biocompatibility requirements intersect with MDR Annex I General Safety and Performance Requirements.
Document Details
Document IDTUVSUD-BIOCOMPAT
TypeNB White Paper
AuthorityTÜV SÜD (NB 0123)
Publication Date2023-05-01