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Product standard finder
Enter an item code, an item name or the name of a standard and the Korean individual product standard in the 「의료기기 기준규격」 notice comes back with its scope clause in full.
What else you get
The international standards (IEC, ISO) that standard cites; the common standards that apply to the item (electrical and mechanical, electromagnetic, biological, Annexes 8 and 9 for implantables, Annexes 6 and 7 for IVD analysers); the basis to use when no individual standard exists (Article 17 of 「의료기기 허가·신고·심사 등에 관한 규정」); and the related standard for single-use items.
Partial item code, Korean item name, English name and the name of the standard are all searchable. Up to 30 results are shown.
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No standard, or not sure?
Where no Korean individual standard exists, performance and safety are demonstrated against the common standards plus the international standards (IEC, ISO) or KS standards that suit the product. Which standard applies depends on the intended use and the construction, so check the notice and the current edition together.
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