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
ÖúÌýÆ÷×¢²á¼ì²â

NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âΪÄúÌṩÖúÌýÆ÷×¢²á¼ì²â£¬ÓµÓйú¼ÒCNAS/CMA×ÊÖÊ£¬¿ÉΪÖúÌýÆ÷²úÎïÉÏÊÐÌṩרҵµÄ²âÊÔ¡¢¼ìÑé¡¢ÉóºË¡¢×ÉѯµÈһվʽ¼¼Êõ·þÎñ¡£ÖúÁ¦ÖúÌýÆ÷²úÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢°ü×°ÔËÊäµÈ²âÊÔ·þÎñ¡£

ÖúÌýÆ÷×¢²á¼ì²â

·çÏÕÆ·¼¶·ÖÀà

• Æøµ¼Ê½ÖúÌýÆ÷£ºÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬Æøµ¼Ê½ÖúÐÐÆ÷ÊôÓÚIIÀàÆ÷е£»·ÖÀà±àÂëΪ19-01-07¡£

• ¹Çµ¼Ê½ÖúÌýÆ÷£ºÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬¹Çµ¼Ê½ÖúÌýÆ÷ÊôÓÚIIÀàÆ÷е£»·ÖÀà±àÂëΪ19-01-07¡£

• Ö²Èëʽ¹Çµ¼ÖúÌýÆ÷£ºÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬Ö²Èëʽ¹Ç´«µ¼ÖúÌýÆ÷ÊôÓÚIIIÀàÒ½ÁÆÆ÷е£»·ÖÀà±àÂëΪ12-03-01¡£

 

ÖúÌýÆ÷×¢²á¼ì²â

NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾ÖúÌýÆ÷¡¿×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢°ü×°ÔËÊäµÈ²âÊÔ·þÎñ¡£

 

ÖúÌýÆ÷²âÊԳ߶È

 

²âÊÔÏîÄ¿

³ß¶È

³ß¶ÈÃû³Æ

µç´Å¼æÈÝ   YY 9706.102-2021   Ò½ÓõçÆøÉ豸 µÚ1-2²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣºµç´Å¼æÈÝ ÒªÇóºÍÊÔÑé
  IEC60601-1-2:2014+A1:2020
Ò½ÁÆÆ÷еµçÆøÄþ¾²   GB 9706.1-2020   Ò½ÓõçÆøÉ豸 µÚ1²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó
  IEC 60601-1:2005/COR3:2022
  YY 9706.111-2021   ÔÚ¼ÒÍ¥»¤Àí»·¾³ÖÐʹÓõÄÒ½ÓõçÆøÉ豸ºÍÒ½ÓõçÆøϵͳµÄÒªÇó
  IEC 60601-1-11:2015,AMD1:2020
  YY/T 9706.106-2021   »ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣº¿ÉÓÃÐÔ
  IEC 60601-1-6:2010+A1:2013+A2:2020
»·¾³   GB/T 14710-2009   Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì
ÐÔÄÜ   IEC 60601-2-66:2019   ÖúÌýÆ÷ºÍÖúÌýÆ÷ϵͳµÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄÌØÊâÒªÇó
  IEC 60118-7:2005   µçÉùѧ-ÖúÌýÆ÷Éú²ú¡¢¹©Ó¦ºÍ½»¸¶ÖÊÁ¿±£Ö¤ÓÃÖúÌýÆ÷ÐÔÄÜÌØÐÔµÄÕÉÁ¿
µç´Å¿¹ÈÅ¶È   IEC 60118-13: 2019   ÖúÌýÆ÷-Òƶ¯Êý×ÖÎÞÏßÉ豸µç´Å¿¹ÈŶȵÄÒªÇóºÍÕÉÁ¿ÒªÁì
ÉúÎïѧÆÀ¼Û   GB/T 16886.1-2022   Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ1²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖеÄÆÀ¼ÛÓëÊÔÑé
  GB/T 16886.5-2017   Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ5²¿ÃÅ£ºÌåÍâϸ°û¶¾ÐÔÊÔÑé
  GB/T 16886.10-2017   Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ10²¿ÃÅ£º´Ì¼¤ÓëƤ·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
°ü×°ÔËÊäÑéÖ¤ GB/T 4857 ASTM D4169ϵÁУ»ISTAϵÁÐ °ü×°ÔËÊä

ÎÂÜ°Ìáʾ£ºÊö³ß¶ÈÖ»ÁÐÉú²úÎï¼¼ÊõÒªÇóÖо­³£Éæ¼°µ½µÄ³ß¶È£¬²¢·ÇÈ«²¿³ß¶È£¬ÆóҵӦƾ¾Ý²úÎïµÄÌصãÒýÓÃһЩÐÐÒµÍâµÄ³ß¶ÈºÍһЩ½ÏΪÌØÊâµÄ³ß¶È¡£

 

ͨÀýÑùÆ·ÒªÇó

ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏß¿Í·þ¡£

 

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¡¢ÎÒÃÇƾ½è±é²¼È«ÇòµÄʵÑéÊÒÍøÂ磬ΪÄúÌṩȫÃæÍêÉƵÄһվʽ²âÊÔÈÏÖ¤½â¾ö·½°¸¡£

 

³£¼ûÎÊÌâ

NG28µÄÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÖÜÆÚÊǶà¾Ã£¿

ʵ¼ÊÖÜÆÚƾ¾ÝίÍеIJúÎï³ß¶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¿

Ïà¹ØÍƼö
ÍøÕ¾µØͼ