×÷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¿¼ì²âΪÄúÌṩ±ÜÔÐÌ××¢²á¼ì²â£¬ÓµÓйú¼ÒCNAS/CMA×ÊÖÊ£¬¿ÉΪ±ÜÔÐÌײúÎïÉÏÊÐÌṩרҵµÄ²âÊÔ¡¢¼ìÑé¡¢ÉóºË¡¢×ÉѯµÈһվʽ¼¼Êõ·þÎñ¡£ÖúÁ¦±ÜÔÐÌײúÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÉúÎïѧÆÀ¼Û¡¢Ãð¾úÑéÖ¤¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤µÈ²âÊÔ·þÎñ¡£
ÔÚÎÒ¹úÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬±ÜÔÐÌײúÎïÊôÓÚIIÀàÒ½ÁÆÆ÷е£»²úÎï·ÖÀà±àÂëΪ18-06-03£¬
×¢£ºº¬ÓÐɱ¾«¼Á¡¢ÑÓʱҩÎïµÄӦΪIIIÀà²úÎï
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾±ÜÔÐÌס¿×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÉúÎïѧÆÀ¼Û¡¢Ãð¾úÑéÖ¤¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤µÈ²âÊÔ·þÎñ¡£
²âÊÔÏîÄ¿ |
³ß¶È |
³ß¶ÈÃû³Æ |
ÉúÎïѧÆÀ¼Û | GB/T 16886.1-2022 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ1²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖÐµÄÆÀ¼ÛÓëÊÔÑé |
GB/T 16886.5-2017 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ5²¿ÃÅ£ºÌåÍâϸ°û¶¾ÐÔÊÔÑé | |
GB/T 16886.10-2017 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ10²¿ÃÅ£º´Ì¼¤ÓëÆ¤·ôÖÂÃôÊÔÑé | |
ISO 10993-1:2018 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | |
ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | |
ISO 10993-10:2021 | Biological evaluation of medical devices Part 10: Tests for skin sensitization | |
Ãð¾úÑéÖ¤ | GB 18280.2/ISO11137-2 | ·øÉäÃð¾ú¼ÁÁ¿É趨 |
GB/T 16886.7/ ISO 10993-7/GB/T 14233.1 | »·ÑõÒÒÍéÃð¾ú²ÐÁôÁ¿£¨EO/ECH£© | |
WS 310.1/WS 310.2/WS 310.3/WS/T 367/GB 18278.1/AAMI TIR30:2011/(R)2016/ AAMI TIR 12-2020/ASTM F3208-20/ ISO 17664/ISO 20857/ISO 25424/ YY/T 0734/ YY/T 1495 | ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤ | |
ÐÔÄÜ | GB 7544-2009 | ÌìÈ»½ºÈéÏ𽺱ÜÔÐÌ×¼¼ÊõÒªÇó¼°ÊÔÑéÒªÁì |
YY/T 1777-2011 | ÄÐÓñÜÔÐÌ× ºÏ³ÉÖÊÁϱÜÔÐÌ×¼¼ÊõÒªÇóÓëÊÔÑéÒªÁì | |
YY/T 1567-2017 | Å®ÓñÜÔÐÌ× ¼¼ÊõÒªÇóÓëÊÔÑéÒªÁì | |
ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤ | YY/T 0681ϵÁÐ | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤ |
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¡£