ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÎÒÃǵķþÎñ

×÷ΪÖйúµÚÈý·½¼ì²âÓëÈÏÖ¤·þÎñµÄ¿ªÍØÕߺÍÁìÏÈÕߣ¬NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âΪȫÇò¿Í»§Ìṩһվʽ¼ìÑé¡¢²âÊÔ¡¢Ð£×¼¡¢ÈÏÖ¤¼°¼¼Êõ·þÎñ¡£

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÐÐÒµ½â¾ö·½°¸

·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£

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÌØÉ«·þÎñ

È«Ãæ±£ÕÏÆ·ÖÊÓëÄþ¾²£¬Íƶ¯ºÏ¹æÓ봴У¬ÕÃÏÔÆ·ÅƾºÕùÁ¦£¬ÊµÏÖ¸ü¸ßÖÊÁ¿¡¢¸ü½¡¿µ¡¢¸üÄþ¾²¡¢¸üÂÌÉ«µÄ¿ÉÁ¬ÐøÉú³¤¡£

¼ÓÈëÎÒÃÇ
È˲ÅÕþ²ß
ÕÐÏÍÄÉÊ¿
ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
È˲ÅÕþ²ß
±£ÕÏÔ±¹¤»ù±¾È¨ÒæÓ븣Àû£»Ìṩרҵ¼¼ÄÜÅàѵ£¬´Ù½øÔ±¹¤Éú³¤£»¿ªÕ¹¸»ºñ¶à²ÊµÄ»î¶¯£¬Æ½ºâÔ±¹¤ÊÂÇéÓëÉú»î¡£
ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÕÐÏÍÄÉÊ¿
»¶Ó­¼ÓÈëÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¸÷ÈËÍ¥£¬ÎÒÃǽ«ÎªÄã´î½¨Ò»¸ö³äʵʩչ²ÅÆø£¬ÊµÏÖÖ°ÒµÀíÏëµÄÎę̀¡£
ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ȨÍþ¹«Õý ͨ±¨ÐÅÈÎ
ÕÃÏÔÆ·ÖÊ µÞÔì¼ÛÖµ
ÇòÄÒÀ©Õŵ¼¹Ü×¢²á¼ì²â

NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âΪÄúÌṩÇòÄÒÀ©Õŵ¼¹Ü×¢²á¼ì²â£¬ÓµÓйú¼ÒCNAS/CMA×ÊÖÊ£¬¿ÉΪÄÒÀ©Õŵ¼¹Ü²úÎïÉÏÊÐÌṩרҵµÄ²âÊÔ¡¢¼ìÑé¡¢ÉóºË¡¢×ÉѯµÈһվʽ¼¼Êõ·þÎñ¡£ÖúÁ¦ÄÒÀ©Õŵ¼¹Ü²úÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÉúÎïѧÆÀ¼Û¡¢Ãð¾úÑéÖ¤¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊäÑéÖ¤µÈ²âÊÔ·þÎñ¡£

ÇòÄÒÀ©Õŵ¼¹Ü×¢²á¼ì²â

·çÏÕÆ·¼¶·ÖÀà

ÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬ÇòÄÒÀ©Õŵ¼¹ÜµÄ·çÏÕ¹ÜÀíÀà±ðΪ¢óÀ࣬·ÖÀà±àÂëΪ03-13-06£»

 

ÇòÄÒÀ©Õŵ¼¹Ü×¢²á¼ì²â

NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾ÇòÄÒÀ©Õŵ¼¹Ü¡¿×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÉúÎïѧÆÀ¼Û¡¢Ãð¾úÑéÖ¤¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊäÑéÖ¤µÈ²âÊÔ·þÎñ¡£

 

ÇòÄÒÀ©Õŵ¼¹Ü¼ì²â³ß¶È

 

²âÊÔÏîÄ¿

³ß¶È

³ß¶ÈÃû³Æ

ÉúÎïѧÆÀ¼Û   GB/T 16886.1-2022   Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ1²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖÐµÄÆÀ¼ÛÓëÊÔÑé
  GB/T 16886.4-2022   Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ4²¿ÃÅ£ºÓëѪҺÏ໥×÷ÓÃÊÔÑéÑ¡Ôñ
  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
  GB/T 16886.11:2021   Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ11²¿ÃÅ£ºÈ«Éí¶¾ÐÔÊÔÑé
  ISO 10993-1:2018   Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
  ISO 10993-4:2017   Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
  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
  ISO 10993-11:2017   Biological evaluation of medical devicesPart 11: Tests for systemic toxicity
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¤
  GB 18280.1:2015   Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉä µÚ1²¿ÃÅ£ºÒ½ÁÆÆ÷еÃð¾ú¹ý³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó
  GB 18280.2:2015   Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉä µÚ2²¿ÃÅ£º½¨Á¢Ãð¾ú¼ÁÁ¿
  GB 18281.2:2015   Ò½ÁƱ£½¡²úÎïÃð¾ú ÉúÎïָʾÎï µÚ2²¿ÃÅ£º»·ÑõÒÒÍéÃð¾úÓÃÉúÎïָʾÎï
ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤   YY/T 0681ϵÁÐ   ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤
°ü×°ÔËÊäÑéÖ¤   GB/T 4857£»ASTM D4169ϵÁУ»ISTAϵÁÐ   °ü×°ÔËÊä
ÎÞ¾úµ¼¹Ü   YY 0285.1-2017   Ѫ¹ÜÄÚµ¼¹ÜÒ»´ÎÐÔʹÓÃÎÞ¾úµ¼¹ÜµÚ1 ²¿ÃÅ£ºÍ¨ÓÃÒªÇó
  YY 0285.4-2017   Ѫ¹ÜÄÚµ¼¹ÜÒ»´ÎÐÔʹÓÃÎÞ¾úµ¼¹ÜµÚ4 ²¿ÃÅ£ºÇòÄÒÀ©Õŵ¼¹Ü

ÎÂܰÌáʾ£ºÊö³ß¶ÈÖ»ÁÐÉú²úÎï¼¼ÊõÒªÇóÖо­³£Éæ¼°µ½µÄ³ß¶È£¬²¢·ÇÈ«²¿³ß¶È£¬ÆóҵӦƾ¾Ý²úÎïµÄÌØµãÒýÓÃһЩÐÐÒµÍâµÄ³ß¶ÈºÍһЩ½ÏÎªÌØÊâµÄ³ß¶È¡£

 

ͨÀýÑùÆ·ÒªÇó

ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏ߿ͷþ¡£

 

ÎÒÃǵÄÓÅÊÆ

1¡¢NG28¾ßÓÐרҵ×ÊÖÊ¡¢¾­Ñ鸻ºñµÄ¼¼Êõר¼ÒÍŶÓ£¬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°¸¡£

 

³£¼ûÎÊÌâ

NG28µÄÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÖÜÆÚÊǶà¾Ã£¿

ʵ¼ÊÖÜÆÚÆ¾¾ÝίÍеIJúÎï³ß¶ÈÀ´È·¶¨£¬ÇëÓëNG28¿Í·þÁªÏµÈ·ÈÏ¡£

NG28Ò½ÁÆÆ÷е¼ì²âµÄ²âÊÔÒªÁìÊÇʲô£¿

Õë¶Ô²úÎïµÄ³ö¿ÚÒªÒÔ¼°¿Í»§Î¯ÍеÄÒªÇ󣬽øÐг߶ȼì²â¡£

NG28¶ÔÓÚÑùÆ·µÄÁôÑùÖÜÆÚÊǶà¾Ã£¿

ÍËÑù¡£

 

·þÎñÁ÷³Ì

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿

Ïà¹ØÍÆ¼ö
ÍøÕ¾µØÍ¼