2021Äê6ÔÂ2ÈÕ£¬Ê³ÎïÇå¾²¹ú¼Ò±ê×¼ÆÀÉóίԱ»áÃØÊé´¦Ðû²¼¡¶Ê³ÎïÇå¾²¹ú¼Ò±ê×¼ Ï¡ÄÌÓÍ¡¢ÄÌÓͺÍÎÞË®ÄÌÓÍ£¨Õ÷ÇóÒâ¼û¸å£©¡·£¬Òâ¼ûÕ÷Çó×èÖ¹2021Äê7ÔÂ20ÈÕ¡£ÓëÏÖÐÐ2010Äê±ê×¼Ïà±È£¬ÓÐÄÄЩת±ä£¿Ê³Îïͬ°éÍø¶ÔÖ÷Ҫת±ä¾ÙÐÐÁËÊáÀí£¬¹©ÒµÄڲο¼¡£
1.ÊõÓïºÍ½ç˵ 
       ÐÞ¶©Ï¡ÄÌÓͽç˵£¬½öÔÊÐíÌí¼ÓʳÎïÌí¼Ó¼Á»òÓªÑøÇ¿»¯¼Á£¬Óëµ÷ÖÆÏ¡ÄÌÓÍ×÷³öÇø±ð¡£ÒÀ¾ÝÐÐÒµµ÷ÑкÍÏÖʵÐèÇó£¬ÐÂÔöµ÷ÖÆÏ¡ÄÌÓ͵Ľç˵£¬ÔÊÐíÌí¼ÓÆäËûʳÎïÖÊÁϵ«²»µÃ°üÀ¨·ÇÈéÔ´ÐÔÖ¬·¾¡£ÐÞ¶©ÄÌÓͺÍÎÞË®ÄÌÓ͵Ľç˵£¬É¾³ý¡°¾­·¢½Í»ò²»·¢½Í¡±µÄ±íÊö£¬ÔÊÐíÄÌÓÍÌí¼ÓÆäËûʳÎïÖÊÁÏ£¬µ«²»µÃÌí¼Ó·ÇÈéÔ´ÐÔÖ¬·¾µÈ¡£
       ¹ØÓÚ´Ë´ÎÐÞ¶©ÖÐÐÂÔöµÄ¡°µ÷ÖÆÏ¡ÄÌÓÍ¡±£¬¹ú¼ÊʳÎï·¨µäίԱ»áÐû²¼µÄ¡¶ÄÌÓͺ;«ÖÆÄÌÓÍ·¨µä±ê×¼¡·£¨CXS 288-1976£©ÖÐÒ²ÓÐÏàËƵķÖÀà¡°µ÷ÅäÏ¡ÄÌÓÍ¡±£¬µ«ÓëÎÒ¹ú»®¶¨ÓÐËù²î±ð¡£ÔÚCXS 288-1976ÖУ¬µ÷ÅäÏ¡ÄÌÓÍÊÇÖ¸ÈéÖÆÆ·µ÷Åä¶ø³ÉµÄÏ¡ÄÌÓÍ£¬¿É¼Ó»ò²»¼ÓÒûÓÃË®£¬×îÖÕ²úÆ·µÄÌصãÓëÏ¡ÄÌÓÍËùÊö²úÆ·µÄÌصãÒ»Ö¡£±ðµÄ£¬¡¶ÄÌÓͺ;«ÖÆÄÌÓÍ·¨µä±ê×¼¡·£¨CXS 288-1976£©»¹Öƶ©ÁËÆäËûµÄ²úÆ··ÖÀ࣬È磺»Ø¸´Ï¡ÄÌÓͺÍÔ¤ÖÆÏ¡ÄÌÓÍ£¬ÇÒ½«Ô¤ÖÆÏ¡ÄÌÓÍÓÖϸ·ÖΪԤ°üװҺ̬ÄÌÓÍ¡¢½Á´òÏ¡ÄÌÓÍ¡¢¼Óѹ°ü×°Ï¡ÄÌÓÍ¡¢½Á´òµÄÏ¡ÄÌÓÍ¡¢·¢½ÍÏ¡ÄÌÓͺÍËữϡÄÌÓÍ¡£
2.Àí»¯Ö¸±ê 
      ÐÂÔöµ÷ÖÆÏ¡ÄÌÓ͵ÄÀí»¯Ö¸±êÒªÇó£¬Ö¸±êÊýÖµÓëÏ¡ÄÌÓÍÒ»Ö¡£½«Ö¬·¾µÄÄ¥Á·ÒªÁìÐÞ¶©ÎªGB 5009.6£¬ÓëÄ¥Á·ÒªÁì±ê×¼µÄµ÷½â¼á³ÖÒ»Öµȡ£
3.΢ÉúÎïÏÞÁ¿
      ɾ³ý¶ÔÖ²¡¾ú£¨½ð»ÆÉ«ÆÏÌÑÇò¾ú¡¢É³ÃÅÊϾú£©µÄÏÞÁ¿»®¶¨£¬¸ÄΪ¡°Ö²¡¾úÓ¦ÇкÏGB 29921µÄ»®¶¨¡±¡£Áí£¬GB 29921ÕýÔÚÐÞ¶©£¬¶øÈéÖÆÆ·ÒÑÄÉÈëÆäÖС£
4.ÆäËû
      ÐÂÔö¡°4 ÆäËû¡±£¬Ã÷È·ÁËÊõÓï¼äµÄµÈЧÐÔ£¬Ö÷Òª°üÀ¨£º²úÆ·±êÇ©Ó¦±êÃ÷²úÆ·ÖÖ±ð

£»¾­·¢½ÍµÄÏ¡ÄÌÓÍ¡¢µ÷ÖÆÏ¡ÄÌÓͿɳÆΪ·¢½ÍÏ¡ÄÌÓÍ¡¢·¢½Íµ÷ÖÆÏ¡ÄÌÓÍ

£»¾­È˹¤µ÷ËáµÄÏ¡ÄÌÓÍ¡¢µ÷ÖÆÏ¡ÄÌÓͿɳÆΪËữϡÄÌÓÍ¡¢Ëữµ÷ÖÆÏ¡ÄÌÓÍ

£»¾­È˹¤µ÷ËáµÄÏ¡ÄÌÓÍ¡¢µ÷ÖÆÏ¡ÄÌÓͿɳÆΪËữϡÄÌÓÍ¡¢Ëữµ÷ÖÆÏ¡ÄÌÓÍ

£»ÄÌÓÍÒ²¿É³ÆΪ»ÆÓÍ£¬ÎÞË®ÄÌÓÍÒ²¿É³ÆΪÎÞË®»ÆÓÍ¡£
      ÏÖÔÚ£¬ÆäËû¹ú¼Ò/µØÇøÏà¹ØµÄ²úÆ·±ê·¨°üÀ¨£¬Öйų́ÍåÐû²¼µÄ¡¶ÈéÖ¬¡·£¨CNS 2878£©ºÍ¡¶ÄÌÓÍ¡·£¨CNS 2877£©

£»¹ú¼ÊʳÎï·¨µäίԱ»áÐû²¼µÄ¡¶»ÆÓÍ¡·£¨CXS 279-1971£©¡¢¡¶ÄÌÓͺ;«ÖÆÄÌÓÍ·¨µä±ê×¼¡·£¨CXS 288-1976£©ºÍ¡¶ÈéÖ¬·¾ÖÆÆ··¨µä±ê×¼¡·£¨CXS 280-1973£©

£»ÃÀ¹úÐû²¼µÄ¡¶Èé¼°ÄÌÓÍ¡·£¨21 CFR PART 131£©

£»°ÄÐÂÐû²¼µÄ¡¶ÄÌÓÍ¡·£¨Standard 2.5.2£©µÈ¡£ÎÒ¹ú´Ë´Î¶ÔÏ¡ÄÌÓÍ¡¢ÄÌÓͺÍÎÞË®ÄÌÓ͵ıê×¼Õ÷ÇóÒâ¼û¸å£¬Ò²ÊÇÔÚµ÷ÑÐÆäËû¹ú¼Ò/µØÇø±ê·¨µÄ»ù´¡ÉÏÐγÉ£¬ÐÅÍÐÕýʽÐû²¼ÊµÑéºó£¬½«ÓÐÀûÓÚÎÒ¹ú¸ÃÐÐÒµÄÚ²úÆ·µÄ¹æ·¶ÐԺͿɲÙ×÷ÐÔ¡£
      Ïà¹Ø±¨µÀ£ºÊ³ÎïÇå¾²¹ú¼Ò±ê×¼ÉóÆÀίԱ»áÃØÊé´¦¹ØÓÚÕ÷Çó¡¶Ï¡ÄÌÓÍ¡¢ÄÌÓͺÍÎÞË®ÄÌÓÍ¡·µÈ23ÏîʳÎïÇå¾²¹ú¼Ò±ê×¼£¨Õ÷ÇóÒâ¼û¸å£©Òâ¼ûµÄº¯£¨Ê³±êÃØ·¢¡²2021¡³6?ºÅ£©