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