×÷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 > ²âÊÔ·þÎñ > Ò½Ò©¼°Ò½Ñ§ > Ò½ÁÆÆ÷е > ·þÎñÏêÇé
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩÎÞÓ°µÆ×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÒ½ÁÆÆ÷еµçÆøÄþ¾²¡¢EMC²âÊÔ¡¢°ü×°ÔËÊä¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤µÈ·þÎñ¡£
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾ÎÞÓ°µÆ¡¿×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÒ½ÁÆÆ÷еµçÆøÄþ¾²¡¢EMC²âÊÔ¡¢°ü×°ÔËÊä¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤µÈ·þÎñ¡£
ƾ¾Ý¡¶Ò½ÁÆÆ÷е·ÖÀàĿ¼¡·£¬ÎÞÓ°µÆµÄ¹ÜÀíÀà±ðΪIIÀà¡£
¹úÄÚ×¢²á-¼ì²â·½°¸
ÏîĿ˵Ã÷ | ³ß¶È±àºÅ | ³ß¶ÈÃû³Æ |
°²¹æ | GB 9706.1-2020 | Ò½ÓõçÆøÉ豸 µÚ1²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó |
YY/T 9706.106-2021 | Ò½ÓõçÆøÉ豸 µÚ1-6²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣº¿ÉÓÃÐÔ | |
GB/T 14710-2009 | Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì | |
YY 9706.241-2020 | Ò½ÓõçÆøÉ豸 µÚ2-41²¿ÃÅ£ºÊÖÊõÎÞÓ°µÆºÍÕï¶ÏÓÃÕÕÃ÷µÆµÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
EMC | YY 9706.102-2021 | Ò½ÓõçÆøÉ豸 µÚ1-2²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣºµç´Å¼æÈÝ ÒªÇóºÍÊÔÑé |
ÐÔÄÜ³ß¶È | GB/T 20145-2006 | µÆºÍµÆϵͳµÄ¹âÉúÎïÄþ¾²ÐÔ |
°ü×°ÔËÊä | GB/T 4857ϵÁÐ | °ü×° ÔËÊä°ü×°¼þ»ù±¾ÊÔÑé |
ÇåÏ´Ïû¶¾Ãð¾ú | WS/T 367£»WS 310.1£»WS 310.2£»WS 310.3 | ÇåÏ´Ïû¶¾¼°Ãð¾ú¼¼Êõ²Ù×÷¹æ·¶ |
¹úÍâ×¢²á-¼ì²â·½°¸
ÏîĿ˵Ã÷ | ³ß¶È±àºÅ | ³ß¶ÈÃû³Æ |
°²¹æ | IEC 60601-1: 2005 + A1: 2012 + A2: 2020 | Ò½ÓõçÆøÉ豸 µÚ1²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó |
IEC 60601-1-6: 2010 + A1: 2013 + A2: 2020 | Ò½ÓõçÆøÉ豸 µÚ1-6²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣº¿ÉÓÃÐÔ | |
IEC 60601-2-41:2021 | Ò½ÓõçÆøÉ豸 µÚ2-41²¿ÃÅ£ºÊÖÊõÎÞÓ°µÆºÍÕï¶ÏÓÃÕÕÃ÷µÆµÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
EMC | IEC 60601-1-2: 2014 + A1: 2020 | Ò½ÓõçÆøÉ豸 µÚ1-2²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣºµç´Å¼æÈÝ ÒªÇóºÍÊÔÑé |
ÐÔÄÜ³ß¶È | IEC 62471:2006 | µÆºÍµÆϵͳµÄ¹âÉúÎïÄþ¾²ÐÔ |
°ü×°ÔËÊä | ASTM D 4169 | °ü×° ÔËÊä°ü×°¼þ»ù±¾ÊÔÑé |
ÇåÏ´Ïû¶¾Ãð¾ú | AAMI TIR12£»AAMI TIR30 £»FDA Guidance | ÇåÏ´Ïû¶¾¼°Ãð¾ú¼¼Êõ²Ù×÷¹æ·¶ |
±¸×¢£ºÉÏÊö³ß¶È°üÂÞÁ˲úÎï¼¼ÊõÒªÇóÖо³£Éæ¼°µ½µÄ³ß¶È£»ÆóÒµÐèҪƾ¾Ý²úÎïµÄÌصãÒýÓÃÆäËûÊÊÓõij߶ȡ£
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¡£