×÷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
ÖúÁ¦³¬ÉùÓ°ÏñÕï¶ÏÉ豸²úÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤¡¢Èí¼þ²âÊÔ¡¢°ü×°ÔËÊäµÈ²âÊÔ·þÎñ¡£
• ÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬³¬ÉùÓ°ÏñÕï¶ÏÉ豸ÓÐIIÀàºÍIIIÀࣨƾ¾Ý×¢²á̽ͷ²îÒ죬·ÖÀàÓÐËù²îÒ죩£»
• ·ÖÀàĿ¼£º³¬ÉùÓ°ÏñÕï¶ÏÉ豸ÊôÓÚ±àÂë 06“Ò½ÓóÉÏñÆ÷е”£¬Ò»¼¶²úÎïÀà±ðΪ07“³¬ÉùÓ°ÏñÕï¶ÏÉ豸”
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾³¬ÉùÓ°ÏñÕï¶ÏÉ豸¡¿Ò»Õ¾Ê½×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ÉúÎïѧÆÀ¼Û¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤¡¢°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 | ||
GB 9706.237-2020 | Ò½ÓõçÆøÉ豸 µÚ2-37²¿ÃÅ£º³¬ÉùÕï¶ÏºÍ¼à»¤É豸µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
IEC 60601-2-37:2007+A1:2015 | ||
»·¾³ | GB/T 14710-2009 | Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì |
½Å̤¿ª¹Ø | YY/T 1057-2016 | Ò½ÓýÅ̤¿ª¹ØͨÓü¼ÊõÌõ¼þ |
BÐͳ¬Éù | GB 10152-2009 | BÐͳ¬ÉùÕï¶ÏÉ豸 |
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 | |
Èí¼þ | GB/T 25000.51-2016 | ϵͳÓëÈí¼þ¹¤³Ì ϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£© µÚ51²¿ÃÅ£º¾ÍÐ÷¿ÉÓÃÈí¼þ²úÎRUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò |
ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤ | GB 18280.2/ISO11137-2 | ·øÉäÃð¾ú¼ÁÁ¿É趨 |
GB/T 16886.7/ ISO 10993-7 | »·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¤ | |
ÎÞ¾úÒ½ÁÆÆ÷е°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/T0681.3-2010/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 |
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¡£