IEC/ISO Standards Recognised by MFDS
MFDS maintains a list of recognised international standards for demonstrating compliance with safety and performance requirements.
Key recognised standardsโ
| Standard | Scope |
|---|---|
| IEC 60601-1 | General electrical safety โ active medical devices |
| IEC 60601-1-2 | Electromagnetic compatibility (EMC) |
| IEC 60601-1-6 | Usability engineering |
| IEC 60601-2-xx | Device-specific particular requirements |
| ISO 14971:2019 | Risk management for medical devices |
| ISO 10993-1 (series) | Biocompatibility evaluation |
| ISO 13485:2016 | QMS for medical devices (basis for KGMP) |
| ISO 14155:2020 | Clinical investigations โ GCP for devices |
| ISO 15223-1 | Symbols for medical device labels |
| ISO 11135 / 11137 | Sterilisation validation (EO / radiation) |
| ISO 11607 | Packaging for terminally sterilised devices |
Confirm the accepted edition
The MFDS recognised standards list specifies the exact edition and year of each standard. Using an older or newer edition without MFDS approval may result in non-compliance findings. Always confirm the currently accepted edition on the official MFDS standards database before commissioning testing.
Related pagesโ
Korean Industrial Standards (KS) Reference
KS standards that mirror or align with ISO equivalents are also recognised by MFDS, including:
- KS C IEC 60601-1 (electrical safety)
- KS A ISO 14971 (risk management)
- KS A ISO 13485 (QMS)
MFDS accepts either ISO or equivalent KS standards; confirm equivalency acceptance with MFDS before testing begins.