×÷ΪÖйúµÚÈý·½¼ì²âÓëÈÏÖ¤·þÎñµÄ¿ªÍØÕߺÍÁìÏÈÕߣ¬NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âΪȫÇò¿Í»§Ìṩһվʽ¼ìÑé¡¢²âÊÔ¡¢Ð£×¼¡¢ÈÏÖ¤¼°¼¼Êõ·þÎñ¡£
·þÎñÄÜÁ¦ÒÑÈ«ÃæÁýÕÖµ½·ÄÖ¯·þ×°¼°Ð¬°ü¡¢Ó¤Í¯Íæ¾ß¼°¼Ò¾ÓÉú»î¡¢µç×ÓµçÆ÷¡¢Ò½Ñ§½¡¿µ¡¢Ê³Æ·¼°Å©²úÎï……µÈÐÐÒµµÄ¹©Ó¦Á´ÉÏÏÂÓΡ£
È«Ãæ±£ÕÏÆ·ÖÊÓëÄþ¾²£¬Íƶ¯ºÏ¹æÓ봴У¬ÕÃÏÔÆ·ÅƾºÕùÁ¦£¬ÊµÏÖ¸ü¸ßÖÊÁ¿¡¢¸ü½¡¿µ¡¢¸üÄþ¾²¡¢¸üÂÌÉ«µÄ¿ÉÁ¬ÐøÉú³¤¡£
Ê×Ò³ > ÎÒÃǵķþÎñ > Ò½Ò©¼°Ò½Ñ§·þÎñ > Ò½ÁÆÆ÷е¼ì²â > ·þÎñÏêÇé
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âΪÄúÌṩѪÌÇÒÇ×¢²á¼ì²â£¬ÓµÓйú¼ÒCNAS/CMA×ÊÖÊ£¬¿ÉΪѪÌÇÒDzúÎïÉÏÊÐÌṩרҵµÄ²âÊÔ¡¢¼ìÑé¡¢ÉóºË¡¢×ÉѯµÈһվʽ¼¼Êõ·þÎñ¡£ÖúÁ¦ÑªÌÇÒDzúÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢Èí¼þ²âÆÀµÈ²âÊÔ·þÎñ¡£
ÔÚÎÒ¹úÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬ÑªÌÇÒǵĹÜÀíÀà±ðΪ¢òÀࣻ·ÖÀà±àÂëΪ22-02-02£¬ÊôÓÚ02Éú»¯·ÖÎöÉ豸 02ѪÌǼ°ÑªÌÇÏà¹Ø²ÎÊý·ÖÎöÒÇÆ÷¡£
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾ÑªÌÇÒÇ¡¿Ò»Õ¾Ê½×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢Èí¼þ²âÆÀµÈ²âÊÔ·þÎñ¡£
²âÊÔÏîÄ¿ |
³ß¶È |
³ß¶ÈÃû³Æ |
Äþ¾²ÒªÇó | GB 4793.1 | ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓÃµçÆøÉ豸µÄÄþ¾²ÒªÇó µÚ1²¿ÃÅ£ºÍ¨ÓÃÒªÇó |
IEC 61010-1 | ||
GB 4793.9 | ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓÃµçÆøÉ豸µÄÄþ¾²ÒªÇó µÚ9²¿ÃÅ£ºÊµÑéÊÒÓ÷ÖÎöºÍÆäËûÄ¿µÄ×Ô¶¯ºÍ°ë×Ô¶¯É豸µÄÌØÊâÒªÇó | |
IEC 61010-2-081 | ||
YY 0648-2008 | ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓÃµçÆø É豸µÄÄþ¾²ÒªÇó µÚ2-101²¿ÃÅ£ºÌåÍâÕï¶Ï£¨IVD£©Ò½ÓÃÉ豸µÄרÓÃÒªÇó | |
IEC 61010-2-101 | ||
»·¾³ÊÔÑéÒªÇó | GB/T 14710 | Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì |
µç´Å¼æÈÝÒªÇó | GB/T 18268.1 | ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõĵçÉ豸 µç´Å¼æÈÝÐÔÒªÇó µÚ1²¿ÃÅ£ºÍ¨ÓÃÒªÇó |
IEC 61326-1 | ||
GB/T 18268.26 | ÕÉÁ¿¡¢¿ØÖƺÍʵÑéÊÒÓõĵçÉ豸 µç´Å¼æÈÝÐÔÒªÇó µÚ26²¿ÃÅ£ºÌØÊâÒªÇó ÌåÍâÕï¶Ï(IVD)Ò½ÁÆÉ豸 | |
IEC 61326-2-6 | ||
ÉúÎïѧÆÀ¼Û | GB/T 16886.1 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ1²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖÐµÄÆÀ¼ÛÓëÊÔÑé |
GB/T 16886.5 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ5²¿ÃÅ£ºÌåÍâϸ°û¶¾ÐÔÊÔÑé | |
GB/T 16886.10 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ10²¿ÃÅ£º´Ì¼¤ÓëÆ¤·ôÖÂÃôÊÔÑé | |
ISO 10993-1 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | |
ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | |
ISO 10993-10 | Biological evaluation of medical devices Part 10: Tests for skin sensitization | |
ISO 10993-23 | Biological evaluation of medical devices Part 23: Tests for irritation | |
Èí¼þ¼°²âÆÀ | GB/T 25000.51 | ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ51²¿ÃÅ£º¾ÍÐ÷¿ÉÓÃÈí¼þ²úÎRUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò¡· |
GB/T 25000.10 | ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ10²¿ÃÅ£ºÏµÍ³ÓëÈí¼þÖÊÁ¿Ä£ÐÍ | |
YY/T 1843-2022 | Ò½ÓÃµçÆøÏµÍ³¼°Ò½ÁÆÆ÷еÈí¼þµÄÍøÂçÄþ¾²»ù±¾ÒªÇó |
ÎÂܰÌáʾ£ºÊö³ß¶ÈÖ»ÁÐÉú²úÎï¼¼ÊõÒªÇóÖо³£Éæ¼°µ½µÄ³ß¶È£¬²¢·ÇÈ«²¿³ß¶È£¬ÆóҵӦƾ¾Ý²úÎïµÄÌØµãÒýÓÃһЩÐÐÒµÍâµÄ³ß¶ÈºÍһЩ½ÏÎªÌØÊâµÄ³ß¶È¡£
ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏ߿ͷþ¡£
1¡¢NG28¾ßÓÐרҵ×ÊÖÊ¡¢¾Ñ鸻ºñµÄ¼¼Êõר¼ÒÍŶӣ¬ÎªÄúÌṩרҵ×ÉѯºÍ·þÎñ¡£
2¡¢NG28ÓµÓÐÏȽøµÄʵÑéÊÒÉ豸£¬È·±£²âÊÔÊý¾ÝµÄ׼ȷºÍ¿É¿¿¡£
3¡¢NG28×÷ΪȫÇò¿Í»§ÐÅÀµµÄµÚÈý·½²âÊÔÈÏÖ¤»ú¹¹£¬ÎÒÃÇÊÇÄúÆ·Öʵı³Êé¡£
4¡¢ÎÒÃÇÆ¾½è±é²¼È«ÇòµÄʵÑéÊÒÍøÂ磬ΪÄúÌá¹©È«ÃæÍêÉÆµÄһվʽ²âÊÔÈÏÖ¤½â¾ö·½°¸¡£
NG28µÄÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÖÜÆÚÊǶà¾Ã£¿
ʵ¼ÊÖÜÆÚÆ¾¾ÝίÍеIJúÎï³ß¶ÈÀ´È·¶¨£¬ÇëÓëNG28¿Í·þÁªÏµÈ·ÈÏ¡£
NG28Ò½ÁÆÆ÷е¼ì²âµÄ²âÊÔÒªÁìÊÇʲô£¿
Õë¶Ô²úÎïµÄ³ö¿ÚÒªÒÔ¼°¿Í»§Î¯ÍеÄÒªÇ󣬽øÐг߶ȼì²â¡£
NG28¶ÔÓÚÑùÆ·µÄÁôÑùÖÜÆÚÊǶà¾Ã£¿
ÍËÑù¡£