ISO 10993
Biological evaluation of medical devices · 10993 · biocompatibility
The biocompatibility standards series for medical devices — what tests are required for what type/duration of body contact. FDA recognises ISO 10993-1:2018 with a modified matrix.
ISO 10993 is a 20+ part series; ISO 10993-1 is the master document that classifies devices by nature and duration of body contact and identifies the biological endpoints (cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, implantation, haemocompatibility…) that must be addressed. The biological evaluation plan and report are required deliverables in MDR / IVDR / FDA submissions.
V5 attaches biological evaluation reports to the DHF and surfaces material-change events that re-trigger evaluation.
- ISO 10993-1:2018
Free trial, no credit card, onboard in days, not months.