×÷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¿¼ì²âΪÄúÌá¹©ÖÆÑõ»ú×¢²á¼ì²â£¬ÓµÓйú¼ÒCNAS/CMA×ÊÖÊ£¬¿ÉÎªÖÆÑõ»úÉ豸²úÎïÉÏÊÐÌṩרҵµÄ²âÊÔ¡¢¼ìÑé¡¢ÉóºË¡¢×ÉѯµÈһվʽ¼¼Êõ·þÎñ¡£ÖúÁ¦ÖÆÑõ»ú²úÎïºÏ¹æ£¬¼øÖ¤ÖÊÁ¿Äþ¾²£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ºôÎüÆøÌåͨ·ÉúÎïÏàÈÝÐÔÆÀ¼Û¡¢ÉúÎïѧÆÀ¼Û¡¢Èí¼þ²âÊÔ¼°ÍøÂçÄþ¾²²âÊÔ¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊäµÈ²âÊÔ·þÎñ¡£
ƾ¾Ý¡¶Ò½ÁÆÆ÷е·ÖÀàĿ¼¡·£¬ÖÆÑõ»úµÄ·çÏÕÆ·¼¶¹ÜÀíÀà±ðIIÀࣻ
NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩ¡¾ÖÆÑõ»ú¡¿Ò»Õ¾Ê½×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºµçÆøÄþ¾²¡¢µç´Å¼æÈÝ¡¢»·¾³ÊÔÑé¡¢ºôÎüÆøÌåͨ·ÉúÎïÏàÈÝÐÔÆÀ¼Û¡¢ÉúÎïѧÆÀ¼Û¡¢Èí¼þ²âÊÔ¼°ÍøÂçÄþ¾²²âÊÔ¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊäµÈ²âÊÔ·þÎñ¡£
³ß¶È˵Ã÷ | ³ß¶È±àºÅ | ³ß¶ÈÃû³Æ |
¹úÄÚ³ß¶È | GB 9706.1-2020 | Ò½ÓÃµçÆøÉ豸 µÚ1²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó |
YY 9706.111-2021 | Ò½ÓÃµçÆøÉ豸µÚ 1-11 ²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó²¢Áг߶ȣºÔÚ¼ÒÍ¥»¤Àí»·¾³ÖÐʹÓõÄÒ½ÓÃµçÆøÉ豸ºÍÒ½ÓÃµçÆøÏµÍ³µÄÒªÇó | |
YY/T 9706.106-2021 | Ò½ÓÃµçÆøÉ豸 µÚ 1-6 ²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó - ²¢Áг߶ȣº¿ÉÓÃÐÔ | |
YY 9706.108-2021 | Ò½ÓÃµçÆøÉ豸 µÚ 1-8 ²¿ÃÅ: »ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶È: ͨÓÃÒªÇó£¬Ò½ÓÃµçÆøÉ豸ºÍÒ½ÓÃµçÆøÏµÖÐͳ±¨¾¯ÏµÍ³µÄ²âÊÔºÍÖ¸ÄÏ | |
YY 9706.269-2021 | Ò½ÓÃµçÆøÉ豸 µÚ2-69²¿ÃÅ£ºÑõÆøÅ¨ËõÆ÷µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
YY 9706.102-2021 | Ò½ÓÃµçÆøÉ豸 µÚ1-2²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣºµç´Å¼æÈÝÒªÇóºÍÊÔÑé | |
GB/T 14710-2009 | Ò½ÓõçÆ÷»·¾³ÒªÇó¼°ÊÔÑéÒªÁì | |
GB/T 16886.1-2022 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ1²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖÐµÄÆÀ¼ÛÓëÊÔÑé | |
GB/T 16886.5-2017 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ5²¿ÃÅ£ºÌåÍâϸ°û¶¾ÐÔÊÔÑé | |
GB/T 16886.10-2017 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ10²¿ÃÅ£º´Ì¼¤ÓëÆ¤·ôÖÂÃôÊÔÑé | |
GB/T 16886.17-2005 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ17²¿ÃÅ£º¿ÉÁ¤ÂËÎïÔÊÐíÏÞÁ¿µÄ½¨Á¢ | |
GB/T 16886.18-2022 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ18²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖÐÒ½ÁÆÆ÷еÖÊÁϵĻ¯Ñ§±íÕ÷ | |
YY/T 1778.1-2021 | Ò½ÁÆÓ¦ÓÃÖкôÎüÆøÌåͨ·ÉúÎïÏàÈÝÐÔÆÀ¼Û µÚ1²¿ÃÅ£º·çÏÕ¹ÜÀí¹ý³ÌÖÐµÄÆÀ¼ÛÓëÊÔÑé | |
YY 0681ϵÁÐ | ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑé | |
GB /T 4857 | °ü×°ÔËÊäÊÔÑé | |
YY/T 1843-2022 | Ò½ÓÃµçÆøÉè±¸ÍøÂçÄþ¾²»ù±¾ÒªÇó | |
GB/T 25000.51-2016 | ϵͳÓëÈí¼þ¹¤³Ì ϵͳÓëÈí¼þÖÊÁ¿ÒªÇóºÍÆÀ¼Û£¨SQuaRE£© µÚ51²¿ÃÅ£º¾ÍÐ÷¿ÉÓÃÈí¼þ²úÎRUSP£©µÄÖÊÁ¿ÒªÇóºÍ²âÊÔϸÔò | |
¹ú¼Ê³ß¶È | IEC 60601-1:2005/COR3:2022 | Ò½ÓÃµçÆøÉ豸 µÚ1²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó |
IEC 60601-1-11:2015,AMD1:2020 | Ò½ÓÃµçÆøÉ豸µÚ 1-11 ²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó²¢Áг߶ȣºÔÚ¼ÒÍ¥»¤Àí»·¾³ÖÐʹÓõÄÒ½ÓÃµçÆøÉ豸ºÍÒ½ÓÃµçÆøÏµÍ³µÄÒªÇó | |
IEC 60601-1-6:2010+A1:2013+A2:2020 | Ò½ÓÃµçÆøÉ豸 µÚ 1-6 ²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó - ²¢Áг߶ȣº¿ÉÓÃÐÔ | |
IEC 60601-1-8:2006+A2:2020 | Ò½ÓÃµçÆøÉ豸 µÚ 1-8 ²¿ÃÅ: »ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶È: ͨÓÃÒªÇó£¬Ò½ÓÃµçÆøÉ豸ºÍÒ½ÓÃµçÆøÏµÖÐͳ±¨¾¯ÏµÍ³µÄ²âÊÔºÍÖ¸ÄÏ | |
ISO 80601-2-69: 2020 | Ò½ÓÃµçÆøÉ豸 µÚ2-69²¿ÃÅ£ºÑõÆøÅ¨ËõÆ÷µÄ»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
ISO 80601-2-67: 2020 | Ò½ÁÆµçÆøÉ豸 µÚ 2-67 ²¿ÃÅ£º´¢Ñõ×°ÖõĻù±¾Äþ¾²ºÍ»ùÌìÐÔÄÜרÓÃÒªÇó | |
IEC 60601-1-2:2014+A1:2020 | Ò½ÓÃµçÆøÉ豸 µÚ1-2²¿ÃÅ£º»ù±¾Äþ¾²ºÍ»ùÌìÐÔÄܵÄͨÓÃÒªÇó ²¢Áг߶ȣºµç´Å¼æÈÝÒªÇóºÍÊÔÑé | |
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 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process | |
ISO 18562-2:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter | |
ISO 18562-3:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic substances | |
ISO 10993-17:2023 | Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents | |
ISO 10993-18:2020/Amd 1:2022 | Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process.Amendment 1: Determination of the uncertainty factor | |
ISTAϵÁÐ / ASTMD 4169 | °ü×°ÔËÊäÊÔÑé | |
ASTM F1980-2016 | ¼ÓËÙÀÏ»¯ÊÔÑé | |
ASTM F88/F88M-2015 | ÈíÐÔÆÁÕÏÖÊÁϵÄÃÜ·âÇ¿¶È | |
ASTM F1140-2013 | ÎÞÔ¼Êø°ü×°¿¹ÄÚÑ¹ÆÆ»µ | |
ASTM F1929-15 | ȾɫҺ´©Í¸·¨²â¶¨Í¸Æø°ü×°µÄÃÜ·âй© | |
ISO 11607-1-2019 ¸½Â¼B£»ASTM F2096-11 | ÄÚѹ·¨¼ì²â´Ö´óй©£¨ÆøÅÝ·¨£© | |
ASTM F1886/F1886M-16 | Ä¿Á¦¼ì²âÒ½Óðü×°ÃÜ·âÍêÕûÐÔ | |
ISO 11607-1:2019 5.2 | Í¸Æø°ü×°ÖÊÁÏʪÐԺ͸ÉÐÔ΢ÉúÎïÆÁÕÏÊÔÑé |
ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏ߿ͷþ¡£
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¡¢ÎÒÃÇÆ¾½è±é²¼È«ÇòµÄʵÑéÊÒÍøÂ磬ΪÄúÌá¹©È«ÃæÍêÉÆµÄһվʽ²âÊÔÈÏÖ¤½â¾ö·½°¸¡£
NG28µÄÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÖÜÆÚÊǶà¾Ã£¿
ʵ¼ÊÖÜÆÚÆ¾¾ÝίÍеIJúÎï³ß¶ÈÀ´È·¶¨£¬ÇëÓëNG28¿Í·þÁªÏµÈ·ÈÏ¡£
NG28Ò½ÁÆÆ÷е¼ì²âµÄ²âÊÔÒªÁìÊÇʲô£¿
Õë¶Ô²úÎïµÄ³ö¿ÚÒªÒÔ¼°¿Í»§Î¯ÍеÄÒªÇ󣬽øÐг߶ȼì²â¡£
NG28¶ÔÓÚÑùÆ·µÄÁôÑùÖÜÆÚÊǶà¾Ã£¿
ÍËÑù¡£