ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÎÒÃǵķþÎñ

×÷ΪÖйúµÚÈý·½¼ì²âÓëÈÏÖ¤·þÎñµÄ¿ªÍØÕߺÍÁìÏÈÕߣ¬NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²âΪȫÇò¿Í»§Ìṩһվʽ¼ìÑé¡¢²âÊÔ¡¢Ð£×¼¡¢ÈÏÖ¤¼°¼¼Êõ·þÎñ¡£

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÐÐÒµ½â¾ö·½°¸

·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£

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÌØÉ«·þÎñ

È«Ãæ±£ÕÏÆ·ÖÊÓëÄþ¾²£¬Íƶ¯ºÏ¹æÓ봴У¬ÕÃÏÔÆ·ÅƾºÕùÁ¦£¬ÊµÏÖ¸ü¸ßÖÊÁ¿¡¢¸ü½¡¿µ¡¢¸üÄþ¾²¡¢¸üÂÌÉ«µÄ¿ÉÁ¬ÐøÉú³¤¡£

¼ÓÈëÎÒÃÇ
È˲ÅÕþ²ß
ÕÐÏÍÄÉÊ¿
ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
È˲ÅÕþ²ß
±£ÕÏÔ±¹¤»ù±¾È¨ÒæÓ븣Àû£»Ìṩרҵ¼¼ÄÜÅàѵ£¬´Ù½øÔ±¹¤Éú³¤£»¿ªÕ¹¸»ºñ¶à²ÊµÄ»î¶¯£¬Æ½ºâÔ±¹¤ÊÂÇéÓëÉú»î¡£
ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ÕÐÏÍÄÉÊ¿
»¶Ó­¼ÓÈëÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¸÷ÈËÍ¥£¬ÎÒÃǽ«ÎªÄã´î½¨Ò»¸ö³äʵʩչ²ÅÆø£¬ÊµÏÖÖ°ÒµÀíÏëµÄÎę̀¡£
ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿
ȨÍþ¹«Õý ͨ±¨ÐÅÈÎ
ÕÃÏÔÆ·ÖÊ µÞÔì¼ÛÖµ
Ò»´ÎÐÔʹÓÃƤ·ô·ìºÏÆ÷×¢²á¼ì²â

NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩһ´ÎÐÔʹÓÃƤ·ô·ìºÏÆ÷×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÉúÎïÏàÈÝÐÔ²âÊÔ¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢Ãð¾úÑéÖ¤¡¢°ü×°ÔËÊäµÈ·þÎñ¡£

Ò»´ÎÐÔʹÓÃƤ·ô·ìºÏÆ÷×¢²á¼ì²â

·çÏÕÆ·¼¶·ÖÀà

ÒÀ¾Ý¡¶Ò½ÁÆÆ÷е·ÖÀàĿ¼¡·£¬Ò»´ÎÐÔʹÓÃƤ·ô·ìºÏÆ÷µÄ¹ÜÀíÀà±ðΪIIÀࣻ·ÖÀà±àÂëΪ02-13-01£»

ÐòºÅ

Ò»¼¶

²úÎïÀà±ð

¶þ¼¶

²úÎïÀà±ð

²úÎïÃèÊö

Ô¤ÆÚÓÃ;

Æ·Ãû¾ÙÀý

¹ÜÀíÀà±ð

13

ÊÖÊõÆ÷е-ÎÇ£¨·ì£©ºÏÆ÷е¼°ÖÊÁÏ

01ÎǺÏÆ÷

£¨´ø¶¤£©

ͨ³£ÓÉÎǺÏÆ÷»ò·ìºÏÆ÷ºÍ¶¤²Ö£¨´ø¶¤£©×é³É¡£ÎǺ϶¤Ò»°ãÓÉîѺϽ𡢴¿îѵȲ»ÐÐÎüÊÕÖÊÁÏÖƳÉ¡£

ÓÃÓÚÌåÄÚÆ÷¹Ù¡¢×éÖ¯µÄÀë¶Ï¡¢ÇгýºÍ/»ò½¨Á¢ÎǺÏ¡££¨²»°üÂÞѪ¹ÜÎǺϣ©

ÎǺÏÆ÷¡¢ÇиîÎǺÏÆ÷¡¢ÄÚ¿ú¾µÎǺÏÆ÷¡¢ÄÚ¿ú¾µÇиîÎǺÏÆ÷¡¢·ìºÏÆ÷¡¢ÄÚ¿ú¾µ·ìºÏÆ÷

¢ò

 

Ò»´ÎÐÔʹÓÃƤ·ô·ìºÏÆ÷×¢²á¼ì²â

NG28ÄϹ¬28NGÏàÐÅÆ·ÅÆÁ¦Á¿¼ì²â¿ÉÒÔΪÄúÌṩһ´ÎÐÔʹÓÃƤ·ô·ìºÏÆ÷×¢²á¼ì²â½â¾ö·½°¸£¬¿ÉÁýÕֵļì²â·þÎñ·¶Î§ÓУºÉúÎïÏàÈÝÐÔ²âÊÔ¡¢ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤¡¢Ãð¾úÑéÖ¤¡¢°ü×°ÔËÊäµÈ·þÎñ¡£

 

Ò»´ÎÐÔʹÓÃƤ·ô·ìºÏÆ÷²âÊԳ߶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 16886.10-2024£¨2025-09-01ʵʩ£©

Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ10²¿ÃÅ£ºÆ¤·ôÖÂÃôÊÔÑé

GB/T 16886.23-2023

£¨2024-12-01ʵʩ£©

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 18279.1-2015

Ò½ÁƱ£½¡²úÎïÃð¾ú »·ÑõÒÒÍé µÚ1²¿ÃÅ£ºÒ½ÁÆÆ÷еÃð¾ú¹ý³ÌµÄ¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó

GB 18279.2-2015

Ò½ÁƱ£½¡²úÎïµÄÃð¾ú »·ÑõÒÒÍé µÚ2²¿ÃÅ£ºGB 18279.1Ó¦ÓÃÖ¸ÄÏ

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¿

ÐÔÄܳ߶È

YY/T 1415-2016

Ƥ·ôÎǺÏÆ÷

YY/T 0149-2006

²»Ðâ¸ÖÒ½ÓÃÆ÷е Ä͸¯Ê´ÐÔÄÜÊÔÑéÒªÁì

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°¸

씀
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 10993-23:2021

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£»

ASTM F2096-11

ÄÚѹ·¨¼ì²â´Ö´óй©£¨ÆøÅÝ·¨£©

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

±¸×¢£ºÉÏÊö³ß¶È°üÂÞÁ˲úÎï¼¼ÊõÒªÇóÖо­³£Éæ¼°µ½µÄ³ß¶È£¬·ÇÈ«²¿³ß¶È£¬ÆóÒµÐèҪƾ¾Ý²úÎïµÄÌصãÒýÓÃÊÊÓõij߶È¡£

 

ͨÀýÑùÆ·ÒªÇó

ÍêÕûÄÜÕý³£ÊÂÇéµÄÑù»ú£¬ÆäËû¾ßÌåÏêÇéÇë×ÉѯNG28ÔÚÏß¿Í·þ¡£

 

ÎÒÃǵÄÓÅÊÆ

1¡¢NG28¾ßÓÐרҵ×ÊÖÊ¡¢¾­Ñ鸻ºñµÄ¼¼Êõר¼ÒÍŶÓ£¬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

ÄϹ¬(28NG¡¤¹ú¼Ê)¹Ù·½ÍøÕ¾-ÏàÐÅÆ·ÅÆÁ¦Á¿

Ïà¹ØÍƼö
ÍøÕ¾µØͼ