9888À­Ë¹Î¬¼Ó˹

9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÎÒÃǵķþÎñ

×÷ΪÖйúµÚÈý·½¼ì²âÓëÈÏÖ¤·þÎñµÄ¿ªÍØÕߺÍÁìÏÈÕߣ¬CTI9888À­Ë¹Î¬¼Ó˹¼ì²âΪȫÇò¿Í»§ÌṩһվʽĥÁ·¡¢²âÊÔ¡¢Ð£×¼¡¢ÈÏÖ¤¼°ÊÖÒÕ·þÎñ¡£

9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÐÐÒµ½â¾ö¼Æ»®

·þÎñÄÜÁ¦ÒÑÖÜÈ«ÁýÕÖµ½·ÄÖ¯´ò°ç¼°Ð¬°ü¡¢Ó¤Í¯Íæ¾ß¼°¼Ò¾ÓÉúÑÄ¡¢µç×ÓµçÆ÷¡¢Ò½Ñ§¿µ½¡¡¢Ê³Îï¼°Å©²úÆ·……µÈÐÐÒµµÄ¹©Ó¦Á´ÉÏÏÂÓΡ£

9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÌØÉ«·þÎñ

ÖÜÈ«°ü¹ÜÆ·ÖÊÓëÇå¾²£¬Íƶ¯ºÏ¹æÓëÁ¢Ò죬ÕÃÏÔÆ·ÅƾºÕùÁ¦£¬ÊµÏÖ¸ü¸ßÖÊÁ¿¡¢¸ü¿µ½¡¡¢¸üÇå¾²¡¢¸üÂÌÉ«µÄ¿ÉÒ»Á¬Éú³¤¡£

¼ÓÈëÎÒÃÇ
È˲ÅÕþ²ß
ÕÐÏÍÄÉÊ¿
9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
È˲ÅÕþ²ß
°ü¹ÜÔ±¹¤»ù±¾È¨ÒæÓ븣Àû£»ÌṩרҵÊÖÒÕÅàѵ£¬Ôö½øÔ±¹¤Éú³¤£»¿ªÕ¹¸»ºñ¶à²ÊµÄ»î¶¯£¬Æ½ºâÔ±¹¤ÊÂÇéÓëÉúÑÄ¡£
9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÕÐÏÍÄÉÊ¿
½Ó´ý¼ÓÈë9888À­Ë¹Î¬¼Ó˹¼ì²â¸÷ÈËÍ¥£¬ÎÒÃǽ«ÎªÄã´î½¨Ò»¸ö³ä·ÖÑéÕ¹²Å»ª£¬ÊµÏÖÖ°ÒµÀíÏëµÄÎę̀¡£
9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ȨÍþ¹«Õý ת´ïÐÅÈÎ
ÕÃÏÔÆ·ÖÊ ´´Á¢¼ÛÖµ
͸Ã÷ÖÊËáÄÆ·óÁÏ×¢²á¼ì²â

CTI9888À­Ë¹Î¬¼Ó˹¼ì²â¿ÉÒÔΪÄúÌṩ͸Ã÷ÖÊËáÄÆ´´Ãæ·óÁÏ×¢²á¼ì²â½â¾ö¼Æ»®£¬¿ÉÁýÕֵļì²â·þÎñ¹æÄ£ÓУºÉúÎïÏàÈÝÐÔ²âÊÔ¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊä¼°ÀÏ»¯ÊµÑé¡¢Ãð¾úÑéÖ¤µÈ·þÎñ¡£

 

͸Ã÷ÖÊËáÄÆ·óÁÏ×¢²á¼ì²â

Σº¦Æ·¼¶·ÖÀà

±¾ÆÚÏÈÈݵÄÒ½ÓÃ͸Ã÷ÖÊËáÄÆ×é³ÉÒòËØÖк¬ÓÐ͸Ã÷ÖÊËáÄÆ»òÕß¾­ÐÞÊεÄ͸Ã÷ÖÊËáÄÆµÄ´´Ãæ·óÁÏ£¬°´µÚ¶þÀàÒ½ÁÆÆ÷е¹ÜÀí£¬·ÖÀà±àÂëÊÇ14-10£¬¸ÃÀà²úÆ·ÁÙ´²ÉÏÓÃÓÚ·ÇÂýÐÔ´´Ãæ¼°ÆäÖÜΧƤ·ôµÄÁýÕÖºÍÕչ˻¤Ê¿¡£

²úÆ·ÐÍʽͨ³£ÓÐÄý½ºÐÍ¡¢ÒºÌåÐÍ¡¢·óÌùÐÍ¡¢¸à¼ÁÐ͵È£¬¿ÉÒÔÎÞ¾ú»ò·ÇÎÞ¾úÐÎʽÌṩ¡£

²úÆ·ÖÐËùº¬ÒòËØ²»¾ßÓÐÒ©Àíѧ×÷Ó㬲»¿É±»ÈËÌåÎüÊÕ¡£

 

 

͸Ã÷ÖÊËáÄÆ´´Ãæ·óÁÏ×¢²á¼ì²â

CTI9888À­Ë¹Î¬¼Ó˹¼ì²â¿ÉÒÔΪÄúÌṩ͸Ã÷ÖÊËáÄÆ·óÁÏ×¢²á¼ì²â½â¾ö¼Æ»®£¬¿ÉÁýÕֵļì²â·þÎñ¹æÄ£ÓУºÉúÎïÏàÈÝÐÔ²âÊÔ¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢°ü×°ÔËÊä¼°ÀÏ»¯ÊµÑé¡¢Ãð¾úÑéÖ¤µÈ·þÎñ¡£

 

͸Ã÷ÖÊËáÄÆ·óÁϲâÊÔ±ê×¼

º£ÄÚ×¢²á-¼ì²â¼Æ»®

ÏîĿ˵Ã÷

±ê×¼±àºÅ

±ê×¼Ãû³Æ

ÉúÎïÏàÈÝÐÔ

GB/T 16886.1-2022

Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ1²¿·Ö£ºÎ£º¦¹ÜÀíÀú³ÌÖÐµÄÆÀ¼ÛÓëÊÔÑé

GB/T 16886.5-2017

Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ5²¿·Ö£ºÌåÍâϸ°û¶¾ÐÔÊÔÑé

GB/T 16886.10-2024

£¨2025-09-01ʵÑ飩

Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ10²¿·Ö£ºÆ¤·ôÖÂÃôÊÔÑé

GB/T 16886.23-2023

£¨2024-12-01ʵÑ飩

Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ23²¿·Ö£º´Ì¼¤ÊÔÑé

GB/T 16886.11-2021

Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ11²¿·Ö£ºÈ«Éí¶¾ÐÔÊÔÑé

͸ƤÊÔÑé

GB/T 27818-2011

»¯Ñ§Æ· Ƥ·ôÎüÊÕ ÌåÍâÊÔÑéÒªÁì

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤

YY 0681.1-2018

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ1²¿·Ö£º¼ÓËÙÀÏ»¯ÊÔÑéÖ¸ÄÏ

YY/T 0681.2-2010

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ2²¿·Ö£ºÈíÐÔÆÁÕÏÖÊÁϵÄÃÜ·âÇ¿¶È

YY/T 0681.3-2010

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ3²¿·Ö£ºÎÞÔ¼Êø°ü×°¿¹ÄÚÑ¹ÆÆËð

YY/T 0681.4-2021

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ4²¿·Ö£ºÈ¾É«Òº´©Í¸·¨²â¶¨Í¸Æø°ü×°µÄÃÜ·â×ß©

YY/T 0681.5-2010

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ5²¿·Ö£ºÄÚѹ·¨¼ì²â´Ö´ó×ß©£¨ÆøÅÝ·¨£©

YY/T 0681.9-2011

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ9²¿·Ö£ºÔ¼Êø°åÄÚ²¿ÆøÑ¹·¨Èí°ü×°ÃÜ·âÕÍÆÆÊÔÑé

YY/T 0681.11-2014

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ11²¿·Ö£ºÄ¿Á¦¼ì²âÒ½Óðü×°ÃÜ·âÍêÕûÐÔ

YY/T 0681.14-2018

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÊÔÑéÒªÁì µÚ14²¿·Ö£ºÍ¸Æø°ü×°ÖÊÁÏʪÐԺ͸ÉÐÔ΢ÉúÎïÆÁÕÏÊÔÑé

GB/T 19633.1-2015

×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×°-ÖÊÁÏ¡¢ÎÞ¾úÆÁÕÏϵͳºÍ°üװϵͳµÄÒªÇó

GB/T 19633.2-2015

×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×°-³ÉÐÍ¡¢ÃÜ·âºÍ×°ÅäÀú³Ì¼òÖ±ÈϵÄÒªÇó

Ãð¾úÑéÖ¤

GB 18278.1-2015

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ʪÈÈ µÚ1²¿·Ö£ºÒ½ÁÆÆ÷еÃð¾úÀú³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó

GB 18280.1-2015

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ·øÉä µÚ1²¿·Ö£ºÒ½ÁÆÆ÷еÃð¾úÀú³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó

GB 18280.2-2015

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ·øÉä µÚ2²¿·Ö£º½¨ÉèÃð¾ú¼ÁÁ¿

GB 18280.3-2015

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ·øÉä µÚ3²¿·Ö£º¼ÁÁ¿ÕÉÁ¿Ö¸ÄÏ

΢ÉúÎïʵÑé

GB/T 19973.1-2023

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ΢ÉúÎïѧҪÁì µÚ1²¿·Ö:²úÆ·ÉÏ΢ÉúÎï×ÜÊý¼òÖ±¶¨

GB/T 19973.2-2018

Ò½ÁÆÆ÷еµÄÃð¾ú ΢ÉúÎïѧҪÁì µÚ2²¿·Ö£ºÓÃÓÚÃð¾úÀú³ÌµÄ½ç˵¡¢È·ÈϺÍά»¤µÄÎÞ¾úÊÔÑé

²úÆ·ÐÔÄÜ

YY/T 1627-2018

¼±ÐÔ´´ÃæÓ÷óÌù¡¢´´ÌùͨÓÃÒªÇó

YY/T 1571-2017

×éÖ¯¹¤³ÌÒ½ÁÆÆ÷е²úƷ͸Ã÷ÖÊËáÄÆ

YY/T 0308-2015

Ò½ÓÃ͸Ã÷ÖÊËáÄÆÄý½º

YY/T 0471.1-2004

½Ó´¥ÐÔ´´Ãæ·óÁÏÊÔÑéÒªÁì µÚ1²¿·Ö£ºÒºÌåÎüÊÕÐÔ

YY/T 0471.2-2004

½Ó´¥ÐÔ´´Ãæ·óÁÏÊÔÑéÒªÁì µÚ2²¿·Ö£ºÍ¸ÆøÄ¤·óÁÏË®ÕôÆû͸¹ýÂÊ

YY/T 0471.3-2004

½Ó´¥ÐÔ´´Ãæ·óÁÏÊÔÑéÒªÁì µÚ3²¿·Ö£º×èË®ÐÔ

YY/T 0471.4-2004

½Ó´¥ÐÔ´´Ãæ·óÁÏÊÔÑéÒªÁì µÚ4²¿·Ö£ºÌñ¾²ÐÔ

YY/T 0471.5-2004

½Ó´¥ÐÔ´´Ãæ·óÁÏÊÔÑéÒªÁì µÚ5²¿·Ö£º×è¾úÐÔ

YY/T 0471.6-2004

½Ó´¥ÐÔ´´Ãæ·óÁÏÊÔÑéÒªÁì µÚ6²¿·Ö£ºÆøÏ¢¿ØÖÆ

°ü×°ÔËÊä

GB/T 4857ϵÁбê×¼

°ü×°ÔËÊäÊÔÑé

 

ÍâÑó×¢²á-¼ì²â¼Æ»®

씀
±ê×¼±àºÅ

±ê×¼Ãû³Æ

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

ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤

ASTM F1980-2016

¼ÓËÙÀÏ»¯ÊÔÑé

ASTM F88/F88M-2015

ÈíÐÔÆÁÕÏÖÊÁϵÄÃÜ·âÇ¿¶È

ASTM F1140-2013

ÎÞÔ¼Êø°ü×°¿¹ÄÚÑ¹ÆÆËð

ASTM F1929-15

ȾɫҺ´©Í¸·¨²â¶¨Í¸Æø°ü×°µÄÃÜ·â×ß©

ISO 11607-1-2019 ¸½Â¼B£»

ASTM F2096-11

ÄÚѹ·¨¼ì²â´Ö´ó×ß©£¨ÆøÅÝ·¨£©

ASTM F1886/F1886M-16

Ä¿Á¦¼ì²âÒ½Óðü×°ÃÜ·âÍêÕûÐÔ

ISO 11607-1:2019 5.2

Í¸Æø°ü×°ÖÊÁÏʪÐԺ͸ÉÐÔ΢ÉúÎïÆÁÕÏÊÔÑé

ISO 11607-1:2019/Amd 1:2023

×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×° µÚ1²¿·Ö£ºÖÊÁÏ¡¢ÎÞ¾úÆÁÕÏϵͳºÍ°üװϵͳµÄÒªÇó

ISO 11607-2:2019/Amd 1:2023

×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×° µÚ2²¿·Ö£º³ÉÐΡ¢ÃÜ·âºÍ×°ÅäÀú³Ì¼òÖ±ÈϵÄÒªÇó

Ãð¾úÑéÖ¤

ISO 17665:2024

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ʪÈÈ µÚ1²¿·Ö£ºÒ½ÁÆÆ÷еÃð¾úÀú³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó

ISO 11137-1:2006/Amd 2:2018

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ·øÉäµÚ1²¿·Ö:Ò½ÁÆÆ÷еÃð¾úÀú³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó

ISO 11137-2:2013/Amd 1:2022

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ·øÉäµÚ2²¿·Ö½¨ÉèÃð¾ú¼ÁÁ¿

ISO 11137-3:2017

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ·øÉäµÚ2²¿·Ö½¨ÉèÃð¾ú¼ÁÁ¿

΢ÉúÎïÊÔÑé

ISO 11737-1:2018/Amd 1:2021

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ΢ÉúÎïѧҪÁì µÚ1²¿·Ö ²úƷ΢ÉúÎïÊýÄ¿µÄ²â¶¨

ISO 11737-2:2019

Ò½ÁƱ£½¡²úÆ·Ãð¾ú ΢ÉúÎïѧҪÁì µÚ2²¿·Ö È·ÈÏÃð¾úÀú³ÌµÄÎÞ¾úÊÔÑé

°ü×°ÔËÊä

ISTAϵÁÐ;ASTM D4169

°ü×°ÔËÊä

±¸×¢£º 1£©ÉÏÊö±ê×¼°üÀ¨Á˲úÆ·ÊÖÒÕÒªÇóÖо­³£Éæ¼°µ½µÄ±ê×¼£¬·ÇËùÓбê×¼£¬ÆóÒµÐèҪƾ֤²úÆ·µÄÌØµãÒýÓÃÊÊÓõıê×¼¡£ 2£©Èô²úÆ·Éæ¼°µ½ÎÞ¾ú״̬½»¸¶£¬ÐèҪ˼Á¿ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢Ãð¾úÑéÖ¤£¬²¢ËµÃ÷ÆäÎÞ¾úÆÁÕÏϵͳµÄÐÅÏ¢£»ÒÔ·ÇÎÞ¾úÐÎʽÌṩµÄ£¬Ó¦µ±ËµÃ÷¼á³ÖÆä΢ÉúÎïÖ¸±êµÄ°ü×°ÐÅÏ¢£»

 

ͨÀýÑùÆ·ÒªÇó

ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËûÏêϸÏêÇéÇë×ÉѯCTIÔÚÏ߿ͷþ¡£

 

ÎÒÃǵÄÓÅÊÆ

1¡¢CTI¾ßÓÐרҵ×ÊÖÊ¡¢ÂÄÀú¸»ºñµÄÊÖÒÕר¼ÒÍŶÓ£¬ÎªÄúÌṩרҵ×ÉѯºÍ·þÎñ¡£

2¡¢CTIÓµÓÐÏȽøµÄʵÑéÊÒ×°±¸£¬È·±£²âÊÔÊý¾ÝµÄ׼ȷºÍ¿É¿¿¡£

3¡¢CTI×÷ΪȫÇò¿Í»§ÐÅÈεĵÚÈý·½²âÊÔÈÏÖ¤»ú¹¹£¬ÎÒÃÇÊÇÄúÆ·Öʵı³Êé¡£

4¡¢ÎÒÃÇÒÀ¸½±é²¼È«ÇòµÄʵÑéÊÒÍøÂ磬ΪÄúÌṩÖÜÈ«ÍêÉÆµÄһվʽ²âÊÔÈÏÖ¤½â¾ö¼Æ»®¡£

 

³£¼ûÎÊÌâ

CTIµÄÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÖÜÆÚÊǶà¾Ã£¿

ÏÖʵÖÜÆÚÆ¾Ö¤Î¯ÍеIJúÆ·±ê×¼À´È·¶¨£¬ÇëÓëCTI¿Í·þÁªÏµÈ·ÈÏ¡£

CTIÒ½ÁÆÆ÷е¼ì²âµÄ²âÊÔÒªÁìÊÇʲô£¿

Õë¶Ô²úÆ·µÄ³ö¿ÚÒªÒÔ¼°¿Í»§Î¯ÍеÄÒªÇ󣬾ÙÐбê×¼¼ì²â¡£

CTI¹ØÓÚÑùÆ·µÄÁôÑùÖÜÆÚÊǶà¾Ã£¿

ÍËÑù¡£

 

·þÎñÁ÷³Ì

9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾

Ïà¹ØÍÆ¼ö
ÍøÕ¾µØÍ¼