Korean Industrial Standards (KS)
Korean Industrial Standards (ํ๊ตญ์ฐ์ ํ์ค, KS) are national standards developed by the Korean Agency for Technology and Standards (KATS). Some KS standards are directly referenced in MFDS notifications as mandatory requirements for certain device types.
KS standards in medical device regulationโ
Most KS standards for medical devices are transpositions of IEC/ISO standards with Korean-specific modifications. Examples:
- KS C IEC 60601-1 (equivalent to IEC 60601-1) โ general safety for electrically-powered devices
- KS P ISO 10993 series โ biocompatibility evaluation
Finding applicable KS standardsโ
The MFDS Classification Table specifies which KS or IEC/ISO standards apply to each device type. Test reports from MFDS-recognised testing laboratories must confirm conformance.