Biocompatibility (ISO 10993)
For devices with direct or indirect patient contact, MFDS requires a biocompatibility evaluation per the ISO 10993 series.
Key standards
| 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)
Surface contacting · External communicating · Implant — combined with contact duration (transient < 24h / short-term ≤ 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 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.
Biocompatibility exemptions and risk-based testing reduction
Not all devices require full ISO 10993 testing. MFDS allows exemptions or reduced testing based on: (1) materials with extensive historical use data and well-established safety (e.g., stainless steel 316L with prior market approval history); (2) devices with no patient contact (e.g., external software-only controllers); and (3) devices manufactured from ISO 10993-certified materials. Manufacturers may request a biocompatibility exemption by providing documented evidence of material safety history, material certification, and a risk justification. However, any novel material, long-term implant contact (>30 days), or systemic absorption potential requires full testing. A biocompatibility exemption request must be pre-approved by MFDS before submission in the STED; retroactive exemption claims may trigger deficiency notices.