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¤@¡BÂåÀø¾¹§÷²¤¶¡G ISO 13485:2003«Y¥ÑISO/TC 210ÂåÀø¾¹§÷«~½èºÞ²z§Þ³N©eû·|©Ò½sÀÀ¡A¥Øªº¦b«P¶i½Õ©MÂåÀø¾¹§÷ªk³W¹ï«~½èºÞ²z¨t²Îªºn¨D¡C¼Ú·ùÂåÀø¾¹§÷«h°Ï¤À¬° ¢°.¥D°Ê´Ó¤J¦¡ÂåÀø¾¹§÷«ü¥O(Active Implantable Medical Devices Directive¡FAIMD)¡C ¢±.¤@¯ëÂåÀø¾¹§÷«ü¥O(Medical Devices Directive¡FMDD),¡C ¢².Åé¥~¶EÂ_ÂåÀø¾¹§÷«ü¥O(In-Vitro Diagnostic Devices Directive¡FIVD)¡A
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