×÷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¿¼ì²â¿ÉÒÔΪÄúÌṩ¼ÒÓúôÎü»ú×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÒ½ÁÆÆ÷еµçÆøÄþ¾²¡¢EMC²âÊÔ¡¢ÉúÎïÏàÈÝÐÔ²âÊÔ¡¢Èí¼þ&ÍøÂçÄþ¾²²âÊÔ¡¢°ü×°ÔËÊä¼°ÀÏ»¯ÊµÑé¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤µÈ·þÎñ¡£
·çÏÕÆ·¼¶·ÖÀà
ÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУº ¼ÒÓúôÎü»ú£¨·ÇÉúÃüÖ§³Ö£©·çÏÕÆ·¼¶¹ÜÀíÀà±ðΪ¢òÀà¡£
¼ÒÓúôÎü»ú£¨ÉúÃüÖ§³Ö£©µÄ·çÏÕÆ·¼¶¹ÜÀíÀà±ðΪ¢óÀà¡£
¼ÒÓúôÎü»ú×¢²á¼ì²â
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾¼ÒÓúôÎü»ú¡¿×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÒ½ÁÆÆ÷еµçÆøÄþ¾²¡¢EMC²âÊÔ¡¢ÉúÎïÏàÈÝÐÔ²âÊÔ¡¢Èí¼þ&ÍøÂçÄþ¾²²âÊÔ¡¢°ü×°ÔËÊä¼°ÀÏ»¯ÊµÑé¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤µÈ·þÎñ¡£
¼ÒÓúôÎü»ú²âÊԳ߶È
¹úÄÚ×¢²á-¼ì²â·½°¸
ÏîĿ˵Ã÷ | ³ß¶È±àºÅ | ³ß¶ÈÃû³Æ |
EMC | YY 9706.102-2021 | µç´Å¼æÈÝÒªÇóºÍÊÔÑé |
°²¹æ | GB 9706.1-2020 | Ò½ÓõçÆøÉ豸 µÚ1²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó |
YY 9706.111-2021 | ÔÚ¼ÒÍ¥»¤Àí»·¾³ÖÐʹÓõÄÒ½ÓõçÆøÉ豸ºÍÒ½ÓõçÆøϵͳµÄÒªÇó | |
YY/T 9706.106-2021 | Ò½ÓõçÆøÉ豸 µÚ 1-6 ²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó - ²¢Áг߶ȣº¿ÉÓÃÐÔ | |
YY 9706.108-2021 | Ò½ÓõçÆøÉ豸ºÍÒ½ÓõçÆøϵÖÐͳ±¨¾¯ÏµÍ³µÄ²âÊÔºÍÖ¸ÄÏ | |
GB/T 14710-2009 | Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì | |
²úÎïÐÔÄÜ³ß¶È | YY 9706.270-2021 | ˯ÃߺôÎüÔÝÍ£ÖÎÁÆÉ豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó |
YY 9706.272-2021 | ÒÀÀµºôÎü»ú»¼ÕßʹÓõļÒÓúôÎü»úµÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
YY 9706.274-2022 | ºôÎüʪ»¯É豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
GB 9706.290-2022 | ¸ßÁ÷Á¿ºôÎüÖÎÁÆÉ豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
ºôÎü»úÅä¼þÐÔÄÜÒªÇó | YY/T 0671-2021 | ˯ÃߺôÎüÔÝÍ£ÖÎÁÆ ÃæÕÖºÍÓ¦Óø½¼þ |
YY/T 0461-2003 | Âé×í»úºÍºôÎü»úÓúôÎü¹Ü· | |
YY/T 1040.1-2015 | Âé×íºÍºôÎüÉ豸 Բ׶½ÓÍ· µÚ1²¿ÃÅ£º×¶Í·Óë׶Ì× | |
YY/T 1040.2-2008 | Âé×íºÍºôÎüÉ豸 Բ׶½ÓÍ· µÚ2²¿ÃÅ£ºÂÝÎƳÐÖؽÓÍ· | |
ÉúÎïÏàÈÝÐÔ | 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 | |
GB/T 16886.11-2021 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ11²¿ÃÅ£ºÈ«È«Éí¶¾ÐÔÊÔÑé | |
YY/T 1778.1-2021 | Ò½ÁÆÓ¦ÓÃÖкôÎüÆøÌåͨ·ÉúÎïÏàÈÝÐÔÆÀ¼Û µÚ1²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖеÄÆÀ¼ÛÓëÊÔÑé | |
Èí¼þ²âÆÀ | GB/T 25000.10 | ϵͳÓëÈí¼þ¹¤³Ì µÚ10²¿ÃÅ£ºÏµÍ³ÓëÈí¼þÖÊÁ¿Ä£ÐÍ |
GB/T 25000.51 | ϵͳÓëÈí¼þ¹¤³Ì µÚ51²¿ÃÅ£º¾ÍÐ÷¿ÉÓÃÈí¼þ²úÎRUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò | |
°ü×°ÔËÊä | GB /T 4857 | °ü×°ÔËÊäÊÔÑé |
ÇåÏ´/Ïû¶¾ÑéÖ¤ | WS 310.1 / WS 310.2 / WS 310.3/WS/T 367 / GB 18278.1/ YY/T 0734 / YY/T 1495 | ¿ÉÖظ´Ê¹ÓÃÒ½ÁÆÆ÷еµÄÇåÏ´Ïû¶¾ÑéÖ¤ |
ÎÞ¾úÒ½ÁÆÆ÷е °ü×°ÑéÖ¤ |
YY 0681ϵÁÐ | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑé |
¹úÍâ×¢²á-¼ì²â·½°¸
ÏîÄ¿ | ³ß¶È±àºÅ | ³ß¶ÈÃû³Æ |
EMC | IEC 60601-1-2:2014+A1:2020 | µç´Å¼æÈÝÒªÇóºÍÊÔÑé |
°²¹æ | IEC 60601-1:2005/COR3:2022 | Ò½ÓõçÆøÉ豸 µÚ1²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó |
IEC 60601-1-11:2015,AMD1:2020 | ÔÚ¼ÒÍ¥»¤Àí»·¾³ÖÐʹÓõÄÒ½ÓõçÆøÉ豸ºÍÒ½ÓõçÆøϵͳµÄÒªÇó | |
IEC 60601-1-6:2010+A1:2013+A2:2020 | Ò½ÓõçÆøÉ豸 ²¢Áг߶ȣº¿ÉÓÃÐÔ | |
IEC 60601-1-8:2006+A2:2020 | Ò½ÓõçÆøÉ豸ºÍÒ½ÓõçÆøϵÖÐͳ±¨¾¯ÏµÍ³µÄ²âÊÔºÍÖ¸ÄÏ | |
²úÎïÐÔÄÜ³ß¶È | ISO 80601-2-70: 2020 | ˯ÃߺôÎüÔÝÍ£ÖÎÁÆÉ豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó |
ISO 80601-2-72: 2023 | ÒÀÀµºôÎü»ú»¼ÕßʹÓõļÒÓúôÎü»úµÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
ISO 80601-2-74: 2021 | ºôÎüʪ»¯É豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
ISO 80601-2-90:2021 | ¸ßÁ÷Á¿ºôÎüÖÎÁÆÉ豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
ÉúÎïÏàÈÝÐÔ | 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 | |
ISO 10993-23:2021 | Biological evaluation of medical devices Part 23: Tests for irritation | |
ISO 10993-11:2017 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity | |
ISO 18562ϵÁÐ | ºôÎüÆø·ÉúÎïÏàÈÝÐÔÆÀ¹À | |
»õ¼ÜÊÙÃü&°ü×°ÔËÊä | ASTM F1980 / ASTM F88/F88M-15 / ASTMF1140/F1140M-13 / ASTMF1929-15 / /ASTMF2096 / ASTMF1886/F1886M / ISO 11607-1 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤ |
ISTAϵÁÐ / ASTMD 4169 | °ü×°ÔËÊäÊÔÑé | |
ÇåÏ´/Ïû¶¾ | AAMI TIR12£»AAMI TIR30 £»FDA Guidance | ¿ÉÖظ´Ê¹ÓÃÒ½ÁÆÆ÷еµÄÇåÏ´Ïû¶¾¼°Ãð¾úÑéÖ¤ |
±¸×¢£ºÉÏÊö³ß¶È°üÂÞÁ˲úÎï¾³£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¡£