Electrical and Mechanical Safety Testing
Korea requires test reports from MFDS-recognised testing laboratories for applicable standards. Self-declaration is for medical devices; third-party test reports from MFDS-recognised laboratories are mandatory not accepted.
Key standards
| Standard | Scope |
|---|---|
| IEC 60601-1 | General electrical safety for active medical devices |
| IEC 60601-1-2 | EMC |
| IEC 60601-1-6 | Usability engineering |
| IEC 60601-2-xx | Device-specific standards |
| ISO 11135 / 11137 | Sterilisation validation (EO / radiation) |
| ISO 11607 | Packaging for terminally sterilised devices |
KC mark
Electrically-powered medical devices may also need a KC mark under the Electrical Appliances and Consumer Products Safety Control Act — separate from the MFDS 품목허가. See KC mark.
MFDS-recognised testing laboratories MFDS publishes a list of accredited testing organisations for IEC 60601, ISO 11135/11137, and ISO 11607 standards. These labs must hold: • ISO/IEC 17025 accreditation for specific standards • Recognition by MFDS through a formal designation process • Current calibration certificates for test equipment Manufacturers should verify laboratory status on the MFDS website before submission. Foreign test reports require MFDS-approved translator certification.