×÷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¿¼ì²âΪÄúÌṩÐĵçͼ»ú×¢²á¼ì²â,ÓµÓйú¼ÒCNAS/CMA×ÊÖÊ,¿ÉΪÐĵçͼ»ú²úÎïÉÏÊÐÌṩרҵµÄ²âÊÔ¡¢¼ìÑé¡¢ÉóºË¡¢×ÉѯµÈһվʽ¼¼Êõ·þÎñ¡£ÖúÁ¦Ðĵçͼ»ú²úÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢Ðĵçͼ»ú²úÎï³ß¶È¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢Èí¼þ²âÆÀ¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤¡¢°ü×°ÔËÊäµÈ²âÊÔ·þÎñ¡£
·çÏÕÆ·¼¶·ÖÀà
ÔÚÎÒ¹úÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬Ðĵçͼ»ú·çÏÕÆ·¼¶¹ÜÀíÀà±ðΪIIÀࣻ·ÖÀà±àÂëΪ07-03-01£»
Ðĵçͼ»ú×¢²á¼ì²â
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾Ðĵçͼ»ú¡¿Ò»Õ¾Ê½×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢Ðĵçͼ»ú²úÎï³ß¶È¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢Èí¼þ²âÆÀ¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤¡¢°ü×°ÔËÊäµÈ²âÊÔ·þÎñ¡£
Ðĵçͼ»ú²âÊԳ߶È
²âÊÔÏîÄ¿ |
³ß¶È |
³ß¶ÈÃû³Æ |
°²¹æ | GB 9706.1-2020£»IEC 60601-1:2005/COR3:2022 | Ò½ÓõçÆøÉ豸 µÚ1²¿ÃÅ£ºÄþ¾²Í¨ÓÃÒªÇó |
GB 9706.225-2021£»IEC 60601-2-25:2011 | Ò½ÓõçÆøÉ豸 µÚ2-25 ²¿ÃÅ£ºÐĵçͼ»úµÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
YY 9706.247-2021£»IEC 60601-2-47:2012£»ANSI/AAMI EC38:2007 | Ò½ÓõçÆøÉ豸 µÚ 2 ²¿ÃÅ:¶¯Ì¬ÐĵçͼϵͳÄþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
YY 0782-2010£»IEC 60601-2-51:2003 | Ò½ÓõçÆøÉ豸 µÚ2-51²¿ÃÅ£º¼Ç¼ºÍ·ÖÎöÐ͵¥µÀºÍ¶àµÀÐĵçͼ»úÄþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
YY 1139-2013£»ANSI/AAMI EC11:1991/(R)2001/(R)2007 | ÐĵçÕï¶ÏÉ豸 | |
YY/T 0196-2005 | Ò»´ÎÐÔʹÓÃÐĵçµç¼« | |
YY 0828-2011£»ANSI/AAMI EC53-2013 | Ðĵç¼à»¤ÒǵçÀº͵¼ÁªÏß | |
EMC | YY 9706.102-2021£»IEC60601-1-2:2014+A1:2020 | Ò½ÓõçÆøÉ豸 µÚ1-2²¿ÃÅ£ºÄþ¾²Í¨ÓÃÒªÇó ²¢Áг߶ȣºµç´Å¼æÈÝÒªÇóºÍÊÔÑé |
»·¾³ÊÔÑé | GB/T 14710-2009 | Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì |
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¤Óë³Ù·¢Ðͳ¬Ãô·´Ó³ÊÔÑé | |
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 | |
ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤ | GB 18280.2/ISO11137-2 | ·øÉäÃð¾ú¼ÁÁ¿É趨 |
GB/T 16886.7/ ISO 10993-7/GB/T 14233.1 | »·ÑõÒÒÍéÃð¾ú²ÐÁôÁ¿£¨EO/ECH£© | |
WS 310.1/WS 310.2/WS 310.3/WS/T 367/GB 18278.1/AAMI TIR30:2011/(R)2016/ AAMI TIR 12-2020/ASTM F3208-20/ ISO 17664/ISO 20857/ISO 25424/ YY/T 0734/ YY/T 1495 | ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤ | |
Èí¼þ¼°²âÆÀ | GB/T 25000.51 | ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ51²¿ÃÅ£º¾ÍÐ÷¿ÉÓÃÈí¼þ²úÎRUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò¡· |
GB/T 25000.10 | ¡¶ÏµÍ³ÓëÈí¼þ¹¤³ÌϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£©µÚ10²¿ÃÅ£ºÏµÍ³ÓëÈí¼þÖÊÁ¿Ä£ÐÍ | |
YY/T 1843-2022 | Ò½ÓõçÆøϵͳ¼°Ò½ÁÆÆ÷еÈí¼þµÄÍøÂçÄþ¾²»ù±¾ÒªÇó | |
ÎÞ¾úÒ½ÁÆÆ÷°ü×°ÑéÖ¤ | GB/T 19633.1/ISO 11607-1/YY/T0681.1-/ASTMF1980-16 | ¼ÓËÙÀÏ»¯ÊÔÑé |
GB/T 19633.1/ISO 11607-1/GB/T 19633.2/ISO 11607-2/YY/T0681.2/ASTM F88/F88M-15 | ·â¿Ú°þÀëÊÔÑ飨ÃÜ·âÇ¿¶È£© | |
YY/T 0681.3-2010/ASTMF1140/F1140M-13 | ÕÇÆÆÊÔÑéºÍÈä±äÊÔÑé | |
YY/T 0681.4-2021/ASTMF1929-15 | ȾÁÏÉø͸ÊÔÑ飨ÃÜ·âй¶£© | |
GB/T 19633.1/ISO 11607-1/YY/T 0681.5-/ASTMF2096/YY/T0681.9/ASTMF2054/F2054M | Õæ¿Õй¶ÊÔÑé | |
YY/T 0681.9 | ÃÜ·âÕÇÆÆÊÔÑé | |
YY/T0681.11/ASTMF1886/F1886M | Ä¿ÊÓÊÔÑé | |
YY/T 0681.14/ ISO 11607-1/DIN 58953-6/GB/T 19633.1/Ïû¶¾¼¼Êõ¹æ·¶ | ΢ÉúÎïÆÁÕϼì²â | |
ÖйúÒ©µä | 𤸽Á¦²â¶¨·¨(³õð¤Á¦µÄ²â¶¨) | |
°ü×°ÔËÊäÑéÖ¤ | GB/T 4857 ASTM D4169ϵÁУ»ISTAϵÁÐ | °ü×°ÔËÊä |
ÎÂÜ°Ìáʾ£ºÊö³ß¶ÈÖ»ÁÐÉú²úÎï¼¼ÊõÒªÇóÖо³£Éæ¼°µ½µÄ³ß¶È£¬²¢·ÇÈ«²¿³ß¶È¡£
ͨÀýÑùÆ·ÒªÇó
ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏß¿Í·þ¡£
ÎÒÃǵÄÓÅÊÆ
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°¸¡£
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