Biocompatibility (ISO 10993)
For devices with direct or indirect patient contact, MFDS requires a biocompatibility evaluation per the ISO 10993 series.
Key standardsโ
| Standard | Scope |
|---|---|
| ISO 10993-1 | Evaluation and testing within risk management |
| ISO 10993-5 | In vitro cytotoxicity |
| ISO 10993-10 | Skin sensitization |
| ISO 10993-11 | Systemic toxicity |
| ISO 10993-18 | Chemical characterization |
Contact categories (ISO 10993-1)โ
Surface contacting ยท External communicating ยท Implant โ combined with contact duration (transient < 24h / short-term โค 30 days / long-term > 30 days) determines required tests.
A biocompatibility evaluation matrix must be included in the STED. Tests must be conducted by a recognised testing laboratory.
Testing laboratories โ Biocompatibility testing must be performed by laboratories accredited to ISO/IEC 17025 or equivalent. MFDS maintains a list of recognised international and Korean testing laboratories. Test reports must include: laboratory accreditation documentation, test protocol compliance with ISO 10993 standards, raw data summaries, and qualified reviewer certification. Foreign test reports must be accompanied by Korean translations.