×÷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¿¼ì²âΪÄúÌṩÊàŦѵÁ·É豸ע²á¼ì²â£¬ÓµÓйú¼ÒCNAS/CMA×ÊÖÊ£¬¿ÉΪÊàŦѵÁ·É豸²úÎïÉÏÊÐÌṩרҵµÄ²âÊÔ¡¢¼ìÑé¡¢ÉóºË¡¢×ÉѯµÈһվʽ¼¼Êõ·þÎñ¡£ÖúÁ¦ÊàŦѵÁ·É豸²úÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢ÉúÎïѧÆÀ¼Û¡¢°ü×°ÔËÊäÑéÖ¤µÈ²âÊÔ·þÎñ¡£
ÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬ÊàŦѵÁ·É豸·çÏÕÆ·¼¶¹ÜÀíÀà±ðÓÐIÀàºÍIIÀࣻ
·ÖÀà±àÂëΪ19-02-05£»ÊôÓÚ19 Ò½Óÿµ¸´Æ÷е£¬02Ô˶¯¿µ¸´ÑµÁ·Æ÷еÖеÄ05ÊàŦѵÁ·É豸£»
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾ÊàŦѵÁ·É豸¡¿×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢ÉúÎïѧÆÀ¼Û¡¢°ü×°ÔËÊäÑéÖ¤µÈ²âÊÔ·þÎñ¡£
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 | ||
»·¾³ | GB/T 14710-2009 | Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì |
½Å̤¿ª¹Ø | YY/T 1057-2016 | Ò½ÓýÅ̤¿ª¹ØͨÓü¼ÊõÌõ¼þ |
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 |
¿µ¸´ÑµÁ·Æ÷е | GB 24436-2009 | ¿µ¸´ÑµÁ·Æ÷е Äþ¾²Í¨ÓÃÒªÇó |
¿µ¸´ÑµÁ·´² | GB/T 20403-2006 | ÆÕͨÀιÌʽ¿µ¸´ÑµÁ·´² |
¿µ¸´ÑµÁ·´² | GB/T 26340-2010 | ¿Éµ÷ʽ¿µ¸´ÑµÁ·´² |
Ö⡢ϥÊàŦ±»¶¯Ô˶¯É豸 | YY/T 0997-2015 | Ö⡢ϥÊàŦ±»¶¯Ô˶¯É豸 |
ÎÂÜ°Ìáʾ£ºÊö³ß¶ÈÖ»ÁÐÉú²úÎï¼¼ÊõÒªÇóÖо³£Éæ¼°µ½µÄ³ß¶È£¬²¢·ÇÈ«²¿³ß¶È£¬ÆóҵӦƾ¾Ý²úÎïµÄÌصãÒýÓÃһЩÐÐÒµÍâµÄ³ß¶ÈºÍһЩ½ÏΪÌØÊâµÄ³ß¶È¡£
ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏß¿Í·þ¡£
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¡¢ÎÒÃÇƾ½è±é²¼È«ÇòµÄʵÑéÊÒÍøÂ磬ΪÄúÌṩȫÃæÍêÉƵÄһվʽ²âÊÔÈÏÖ¤½â¾ö·½°¸¡£
NG28µÄÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÖÜÆÚÊǶà¾Ã£¿
ʵ¼ÊÖÜÆÚƾ¾ÝίÍеIJúÎï³ß¶ÈÀ´È·¶¨£¬ÇëÓëNG28¿Í·þÁªÏµÈ·ÈÏ¡£
NG28Ò½ÁÆÆ÷е¼ì²âµÄ²âÊÔÒªÁìÊÇʲô£¿
Õë¶Ô²úÎïµÄ³ö¿ÚÒªÒÔ¼°¿Í»§Î¯ÍеÄÒªÇ󣬽øÐг߶ȼì²â¡£
NG28¶ÔÓÚÑùÆ·µÄÁôÑùÖÜÆÚÊǶà¾Ã£¿
ÍËÑù¡£