IEC/ISO Standards Recognised by MFDS
MFDS maintains an official list of recognised international standards (IEC, ISO, and equivalent Korean Industrial Standards) for demonstrating compliance with safety and performance requirements. The list specifies exact editions and years; using unapproved editions may result in non-compliance findings.
Key recognised standards
| Standard | Scope |
|---|---|
| IEC 60601-1 | General electrical safety — 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 — 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 pages
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.