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 recognised list may reference a specific edition. Confirm the accepted edition with MFDS before testing.