×÷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´ÉÏÏÂÓÎ ¡£
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¿ÉÒÔΪÄúÌṩ²»ÐÐÎüÊÕ·ìºÏÏß×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУº£ºÉúÎïÏàÈÝÐÔ²âÊÔ¡¢Ãð¾úÑéÖ¤¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊäµÈ·þÎñ ¡£
·çÏÕÆ·¼¶·ÖÀà
ÔÚÎÒ¹úµÄÒ½ÁÆÆ÷еע²á¹ÜÀíÖУ¬£¬²»ÐÐÎüÊÕ·ìºÏÏߵĹÜÀíÀà±ðΪIIÀࣻ·ÖÀà±àÂë02-13-07£»
²»ÐÐÎüÊÕ·ìºÏÏß×¢²á¼ì²â
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ²»ÐÐÎüÊÕ·ìºÏÏß×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУº£ºÉúÎïÏàÈÝÐÔ²âÊÔ¡¢ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊä¼°ÀÏ»¯ÊµÑéµÈ·þÎñ ¡£
²»ÐÐÎüÊÕ·ìºÏÏß²âÊԳ߶È
¹úÄÚ×¢²á-¼ì²â·½°¸
| ÏîĿ˵Ã÷ | ³ß¶È±àºÅ | ³ß¶ÈÃû³Æ |
| 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«Éí¶¾ÐÔÊÔÑé | |
| GB/T 16886.23-2023 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ23²¿ÃÅ£º´Ì¼¤ÊÔÑé | |
|
ÎÞ¾úÒ½ÁÆÆ÷е °ü×°ÑéÖ¤ |
YY 0681.1-2018 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ1²¿ÃÅ£º¼ÓËÙÀÏ»¯ÊÔÑéÖ¸ÄÏ |
| YY/T 0681.2-2010 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ2²¿ÃÅ£ºÈíÐÔÆÁÕÏÖÊÁϵÄÃÜ·âÇ¿¶È | |
| YY/T 0681.3-2010 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ3²¿ÃÅ£ºÎÞÔ¼Êø°ü×°¿¹ÄÚѹÆÆ»µ | |
| YY/T 0681.4-2021 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ4²¿ÃÅ£ºÈ¾É«Òº´©Í¸·¨²â¶¨Í¸Æø°ü×°µÄÃÜ·âй© | |
| YY/T 0681.5-2010 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ5²¿ÃÅ£ºÄÚѹ·¨¼ì²â´Ö´óй©£¨ÆøÅÝ·¨£© | |
| YY/T 0681.9-2011 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ9²¿ÃÅ£ºÔ¼Êø°åÄÚ²¿Æøѹ·¨Èí°ü×°ÃÜ·âÕÍÆÆÊÔÑé | |
| YY/T 0681.11-2014 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ11²¿ÃÅ£ºÄ¿Á¦¼ì²âÒ½Óðü×°ÃÜ·âÍêÕûÐÔ | |
| YY/T 0681.14-2018 | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ14²¿ÃÅ£ºÍ¸Æø°ü×°ÖÊÁÏʪÐԺ͸ÉÐÔ΢ÉúÎïÆÁÕÏÊÔÑé | |
| GB/T 19633.1 | ×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×°-ÖÊÁÏ¡¢ÎÞ¾úÆÁÕÏϵͳºÍ°üװϵͳµÄÒªÇó | |
| GB/T 19633.2 | ×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×°-³ÉÐÍ¡¢ÃÜ·âºÍ×°Åä¹ý³Ì¼òÖ±ÈϵÄÒªÇó | |
| Ãð¾úÑéÖ¤ | GB 18278.1-2015 | Ò½ÁƱ£½¡²úÎïÃð¾ú ʪÈÈ µÚ1²¿ÃÅ£ºÒ½ÁÆÆ÷еÃð¾ú¹ý³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó |
| GB 18280.1-2015 | Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉä µÚ1²¿ÃÅ£ºÒ½ÁÆÆ÷еÃð¾ú¹ý³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó | |
| GB 18280.2-2015 | Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉä µÚ2²¿ÃÅ£º½¨Á¢Ãð¾ú¼ÁÁ¿ | |
| GB 18280.3-2015 | Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉä µÚ3²¿ÃÅ£º¼ÁÁ¿ÕÉÁ¿Ö¸ÄÏ | |
| GB/T 16886-7-2015 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ7²¿ÃÅ£º»·ÑõÒÒÍéÃð¾ú²ÐÁôÁ¿ | |
| ÐÔÄÜ³ß¶È | YY 0167-2020 | ·Ç¿ÉÎüÊÕÐÔÍâ¿Æ·ìÏß |
| YY/T 0043-2016 | Ò½Ó÷ìºÏÕë | |
| GB/T 14233.1-2020 | Ò½ÓÃÊäÒº¡¢ÊäѪ¡¢×¢ÉäÆ÷¾ß¼ìÑéÒªÁì µÚ1²¿ÃÅ£º»¯Ñ§·ÖÎöÒªÁì | |
| GB/T 14233.2-2005 | Ò½ÓÃÊäÒº¡¢ÊäѪ¡¢×¢ÉäÆ÷¾ß¼ìÑéÒªÁì µÚ2²¿ÃÅ£ºÉúÎïѧÊÔÑéÒªÁì |
¹ú¼Ê×¢²á-¼ì²â·½°¸
| ÏîÄ¿ | ³ß¶È±àºÅ | ³ß¶ÈÃû³Æ |
| 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 10993-11:2017 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity | |
| ISO 10993-23:2021 | Biological evaluation of medical devices Part 23: Tests for irritation | |
| ÎÞ¾úÒ½ÁÆÆ÷е °ü×°ÑéÖ¤ |
ASTM F1980-2016 | ¼ÓËÙÀÏ»¯ÊÔÑé |
| ASTM F88/F88M-2015 | ÈíÐÔÆÁÕÏÖÊÁϵÄÃÜ·âÇ¿¶È | |
| ASTM F1140-2013 | ÎÞÔ¼Êø°ü×°¿¹ÄÚѹÆÆ»µ | |
| ASTM F1929-15 | ȾɫҺ´©Í¸·¨²â¶¨Í¸Æø°ü×°µÄÃÜ·âй© | |
| ISO 11607-1-2019 ¸½Â¼B£» | ÄÚѹ·¨¼ì²â´Ö´óй©£¨ÆøÅÝ·¨£© | |
| ASTM F2096-11 | ||
| ASTM F1886/F1886M-16 | Ä¿Á¦¼ì²âÒ½Óðü×°ÃÜ·âÍêÕûÐÔ | |
| ISO 11607-1:2019 5.2 | ͸Æø°ü×°ÖÊÁÏʪÐԺ͸ÉÐÔ΢ÉúÎïÆÁÕÏÊÔÑé | |
| Ãð¾úÑéÖ¤ | ISO 11135 | Ò½ÁƱ£½¡²úÎïÃð¾ú »·ÑõÒÒÍé Ò½ÁÆÆ÷еÃð¾ú¹ý³Ì¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó |
| ISO11137-1 | Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉäµÚ1²¿ÃÅ:Ò½ÁÆÆ÷еÃð¾ú¹ý³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó | |
| ISO11137-2 | Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉäµÚ2²¿ÃŽ¨Á¢Ãð¾ú¼ÁÁ¿ | |
| ISO 10993-7 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ7²¿ÃÅ »·ÑõÒÒÍé²ÐÁôÁ¿ | |
| ISO 11607-1 | ×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×° µÚ1²¿ÃÅ£ºÖÊÁÏ¡¢ÎÞ¾úÆÁÕÏϵͳºÍ°üװϵͳµÄÒªÇó | |
| ISO 11607-2 | ×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×° µÚ2²¿ÃÅ£º³ÉÐΡ¢ÃÜ·âºÍ×°Åä¹ý³Ì¼òÖ±ÈϵÄÒªÇó | |
| ISO 11737-1 | Ò½ÁƱ£½¡²úÎïÃð¾ú ΢ÉúÎïѧҪÁì µÚ1²¿ÃÅ ²úÎï΢ÉúÎïÊýÁ¿µÄ²â¶¨ | |
| ISO 11737-2 | Ò½ÁƱ£½¡²úÎïÃð¾ú ΢ÉúÎïѧҪÁì µÚ2²¿ÃÅ È·ÈÏÃð¾ú¹ý³ÌµÄÎÞ¾úÊÔÑé | |
| °ü×°ÔËÊä | ISTAϵÁÐ;ASTM D4169 | °ü×°ÔËÊä |
±¸×¢£º 1£©ÉÏÊö³ß¶È°üÂÞÁ˲úÎï¼¼ÊõÒªÇóÖо³£Éæ¼°µ½µÄ³ß¶È£¬·ÇÈ«²¿³ß¶È£¬ÆóÒµÐèҪƾ¾Ý²úÎïµÄÌصãÒýÓÃÊÊÓÃµÄ³ß¶È ¡£ 2£©Èô²úÎïÉæ¼°µ½ÎÞ¾ú״̬£¬½¨Ò鿼ÂÇÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢Ãð¾úÑéÖ¤£»
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 ¡£
Á®ÕþÉùÃ÷ | Òþ˽Õþ²ß | È«Çò·þÎñÍøÂç | ÍøÕ¾µØͼ | ͶËß¾Ù±¨ | ×ÔÎÒÉùÃ÷ | Ö´·¨ÉùÃ÷ | ¼ì²â·þÎñͨÓÃÌõ¿î Copyright Centre Testing International All rights reserved
ÔÁICP±¸10021358ºÅ 
ÔÁ¹«Íø°²±¸ 44030602000441ºÅ
