Ò½ÁÆ°ü×°ÊÇÖ¸¶ÔÒ½ÁÆÆ÷еµÄ³õ°ü×°£¬£¬£¬¿É¶ÔÆä½øÐÐÃð¾ú£¬£¬£¬¿É½øÐÐÎÞ¾ú²Ù×÷£¨Èç¸É¾»¿ªÆô£©£¬£¬£¬ÄÜÌṩ¿É½ÓÊܵÄ΢ÉúÎï×è¸ô»úÄÜ£¬£¬£¬Ãð¾úÇ°ºóÄܶԲúÆ·½øÐб£»£»¤²¢ÇÒÃð¾úºóÄÜÔڿ϶¨ÆÚÏÞÄÚ£¨±ê×¢µÄÓÐЧÆÚ£©Î¬³ÖϵͳÄÚ²¿ÎÞ¾ú»·¾³µÄ°üװϵͳ¡£

¿ÉÊʺϵÄÃð¾ú·½Ê½£º£ºETO»·ÑõÒÒÍé¡¢¸ßÎÂʪÈÈÕôÆû£¬£¬£¬gammaîÜ60ÉäÏß·øÕÕ¡¢µÈÀë×Ó¡¢¼×È©µÈ¡£

½á¹¹×é³É£º£º´ü×Ó»òÕßÎüËܺÐ

¡ñ´ü×Ó£º£ºÖ½ËÜ´üºÍ Ö½Ö½´üΪÖ÷£¨Ö½ËÜ´ü¶àΪÃÀ¹úÖ½£¬£¬£¬·¨¹úÖ½£¬£¬£¬Ó¢¹úÖ½£»£»Ö½Ö½´üΪ¹ú²úÖ½£©¡£

¡ñÎüËܺУº£ºÎüËÜ×ÊÁÏPET¡¢»òÕßPP¡¢»òÕßPETGµÈ×é³ÉµÄÎüËܺÐÍâ ÈÈ·âÒ½ÓÃÍ¿½ºÖ½£¬£¬£¬Ä¿Ç°¶àΪ¶Å°îÌØÎÀÇ¿ÎüËܸDzÄTyvekÍ¿½ºÖ½¡£

¶ÔÏ󣺣ºÒ½ÁÆÆ÷е³§¼ÒºÍҽԺΪÖ÷¡£

·â¿Ú´ó¾Ö£º£ºÈÈѹ·â¿Ú»ú·âºÍË«Ã潺×Ô·´¿ÛÕ³ºÏ·â¡£

ÖÊÁ¿³ß¶È£º£º¹ú¼ÊΪISO11607£»£»Å·ÃËΪEN868£»£»ÖйúΪGB/T19633¡£

°ü×°µÀÀí£º£º×°ÈëÆ÷е£¬£¬£¬·â¿Ú£¬£¬£¬Ãð¾ú£¬£¬£¬´ü×Ó×è¾ú͸¹ýÃð¾úÒò×ӵĵÀÀíÄܹ»±£Áô1-5Ä꣬£¬£¬´ïµ½Ò½ÓÃÃð¾ú°ü×°´üµÄ×è¸ô×÷Óá£

Ö°ÄÜ×÷ÓÃ:½«Äâ×îÖÕÃð¾úµÄÆ÷еװÈë°ü×°´üÄÚ£¬£¬£¬¾­ÃÜ·âºó£¬£¬£¬¿Éͨ¹ýÎïÀí»ò»¯Ñ§µÄ²½Ö裬£¬£¬½«´üÌåÄÚÆ÷еÉϵÄ΢ÉúÎïɱÃ𣬣¬£¬²¢ÄÜÔÚ»®¶¨µÄЧÆÚÄÚ£¬£¬£¬Î¬³Ö´üÄÚµÄÆ÷е´¦ÓÚÎÞ¾ú״̬¡£¾ßÌå¿ÉÔ̺¬ÒÔϹ¦ÄÜ£º£º

¡¡¡¡—¿ÉÊÊÓ¦ÏàÓ¦µÄÃð¾ú¹ý³Ì£»£»

¡¡¡¡—±£»£»¤Æ÷е£¬£¬£¬Ê¹Æ÷еά³ÖÔÚÒ»¸ö¿É½ÓÊܵÄʹÓÃÇ°ÌáÏ£»£»

¡¡¡¡—ÓµÓÐϸ¾ú×è¸ô»úÄÜ£¬£¬£¬Ê¹ÓÃÇ°¿Éά³ÖÆ÷еµÄÎÞ¾úÐÔºÍÆëÈ«ÐÔ£»£»¡¡

¡¡¡¡—Äܹ»ÎÞ¾ú¿ªÆô£¬£¬£¬ÒÔʹÓÃÆ÷е£»£»¡¡

¡¡¡¡—ÕýÈ·µØ¼ø±ðÓëʹÓòúÆ·¡£

ÖÊÁ¿¼¼ÊõÒªÇ󣺣º

1¡¢Ô̺¬×ÊÁϱØÐëÓÐЧ×è¸ô΢ÉúÎï/ϸ¾ú ASTM F-1608£»£»

2¡¢±ØÐëÊÊÓ¦³ÐŵµÄÃð¾ú·½Ê½ISO11134\ISO11135\ISO11137£»£»

3¡¢Î¬³Ö²úÆ·µÄÎÞ¾ú״̬¡£°ü×°²»³ÉÄÜÓб»¿ÕÆø´«È¾£¬£¬£¬ÏËάÆÆË𣬣¬£¬³¾°£µÈÍâÀ´Î£¬£¬Î¢ÉúÎïÇÖÈëµÄ»úÓö£¨ASTM D- 2019£©¡£Òò¶ø£¬£¬£¬°ü×°ÐèÈ·±££º£º

--Ô̺¬×ÊÁÏÎÞÆÆË𣻣»

--·âºÏÆëÈ«£¬£¬£¬°þÀëÇ¿¶È£¨ASTM F88£©ºÏÊÊ£¬£¬£¬ÎÞÉøÈ루ASTM :1998£©£¬£¬£¬ÎÞ±¬ÆÆ(ASTM F-1150 / ASTM F-2054)¡¢°þÀë¸É¾»£¨EN868-5£©¡£

4¡¢Ô̺¬×ÊÁÏ»ò°ü×°ºóÐøÓ¦ÒËÓÚ±»¼Ó¹¤£»£»

¡¡ ×ÊÁÏÖÆ×÷µÄʱÐë×î´óˮƽµÄÏ÷¼õ¿ÅÁ£µÄÍÑÂ䣬£¬£¬ÀýÈçÏËά£¬£¬£¬±¡Æ¬, ÓÍÄ«ÍÑÂä, ³¾°£¡££¨ASTM D-2019 £»£»

5¡¢°ü×°¿ªÆôºó, Ó¦ÓÐÏÔÖøµÄºÛ¼£ÏÔʾÔø±»´ò¿ª¹ý£»£»

¡¡ °ü×°Æô·â¿Ú¿ªÆôºó£¬£¬£¬²»Ó¦ÓÐËÁÒâÔÙ·âºÏÐÔ¡££¨Ô¤·À°ü×°´ò¿ª±»´«È¾¶øºóÔÙÖØкÏÉÏ£©£»£»

6¡¢Ó¦±êʶ¿ªÆôµØλºÍ·½Ïò£»£»

¡¡ Ó¦Ò×ÓÚ¿ª·â£¬£¬£¬ÇÒ¿ª·âµØλӦ·½±ãʹÓÃÕß´ò¿ªÆô£¨EN980£©£»£»

7¡¢±ØÐëÄܹ»Èϱð²úÆ·£¨Ó¡Ë¢ßéÍ·Ó¦ÇкÏÒ½Æ÷е˾·¨ÂɹæÒªÇ󣬣¬£¬Ô̺¬×ÊÁÏÓÐÒ»ÃæͨÃ÷µÄ×ÊÁÏ£¬£¬£¬Äܹ»¿´µ½ÄÚ²¿µÄ²úÆ·£©EN980 £»£»

Ò½ÁÆÆ÷еÃð¾ú°ü×°£­»¯Ñ§Åúʾ¼Á¼°Ó¡Ë¢Ä«Ë®

1¡¢Ãð¾ú±äÉ«»¯Ñ§Åúʾ¼Á£¬£¬£¬¸Ã²úÆ·ÀàËÆÓÚӡˢīˮ£¬£¬£¬¼Ó¹¤µÀÀíͬӡˢī£¬£¬£¬Í¨³£½«ÆäÓ¡Ë¢ÓÚ°ü×°´üÄÚ»òÍⲿ¡£ÆäµÀÀíΪÔÚÌض¨µÄÃð¾úÇ°ÌáÏ£¬£¬£¬Åúʾ¼ÁÓ¡Ä«Óɳõʼɫ²ÊÔì³ÉÔ¤ÏÈÉ趨µÄÉ«²Ê¡£Ö°ÄÜÔÚÓÚÖ±¹ÛµØÅú×¢Ãð¾ú²úÆ·ÊÇ·ñ¾­¹ý²¢Çкϻ®¶¨µÄÃð¾úÇ°Ìá¡£Ãð¾ú±äÉ«»¯Ñ§Åúʾ¼Á·ÖΪˮÐÔºÍÓÍÐÔ£¬£¬£¬Çø±ðÔÚÓÚË®ÐÔ²»º¬ÖؽðÊô¡£

2¡¢Ó¡Ë¢Ä«Ë®£¬£¬£¬Í¨³£·ÖΪˮÐÔºÍÓÍÐÔ£¬£¬£¬»ùÓÚÒ½ÁƲúÆ·µÄÖÊÁ¿ÒªÇ󣬣¬£¬Ò½ÁÆ°üװͨ³£Ê¹ÓÃË®ÐÔ»·°üÐÍÄ«Ë®£¬£¬£¬¸ÃīˮӦͨ¹ýISO10993ÉúÎï¼æÈÝÐÔ¼ìÑ飬£¬£¬ÖؽðÊôº¬Á¿ÇкÏIEC 62321,US EPA 3052ÒªÇó¡£

 

Ò½ÁÆÆ÷еÃð¾ú°ü×° –ͨÀýÖÆ×÷¹¤ÒÕµÀÀí

͸ÎöÖ½

¡¡¡¡→ľ½¬Ë®½â→ÆÌÍø¡¢¹õѹ¡¢ºæ¸É¾«ÖÆÖ½ÕÅ→ÊÕ¾í→·ÖÇÐ→°ü×°¡££¨×ÔÕ³Óë·Ç×ÔÕ³Ö½µÄÖØÒªÇø±ðΪÔÚÔìÖ½³ÉÐ͹ý³ÌÖУ¬£¬£¬ÔÚÖ½µÄÀíÂÛÇÖÅÝ»¯¹¤Ô­ÁÏ£©

¸´ºÏĤ£¨¸´ºÏ»ú£©

¡¡¡¡→ÅäÑ¡ÁÏÁ£→´µÄ¤»òÁ÷ÑÓ³ÉĤÁÏ→¶þ²ã»ò¶à³ÉԤѡĤ¸´ºÏ¶ø³É¡£

¡¡¡¡´µÄ¤¹²¼Á»òÁ÷ÑÓ¹²¼ÁĤ£¨´µÄ¤»ú»òÁ÷ÑÓ»ú£©

¡¡¡¡→¶þÖÖÒÔÉϵÄÏàÕ³ÈÜÁÏÁ£→¶à²ã´µÄ¤»ò¶à²ãÁ÷ÑÓ¹²¼Á³ÉÐÍĤÁÏ→ÊÕ¾í→·ÖÇÐ→°ü×°¡£

ÁÜĤ£¨ÁÜĤ»ú£©

¡¡¡¡→ÔÚÖ½ÕÅ»òÆä»ù²ÄÉÏ£¬£¬£¬½«ËÜÁÏÁ£×Óͨ¹ýÁÜĤÉ豸¸ßÎÂÈÜ»¯£¬£¬£¬¶øºóͨ¹ý¿Éµ÷½Úºñ¶ÈµÄģͷ΢¿×ÖÐÁÜÔÚ»ù²ÄÉÏ£¬£¬£¬¶øºóÀäÈ´³ÉÐÍ¡£

Í¿²ãÁÏ£¨Í¿²¼»ú£©

¡¡¡¡→ÔÚÖ½ÕÅ»òÆäËü»ù²ÄÉÏ£¬£¬£¬Í¨¹ýÍøÎƹõ£¬£¬£¬½«Ô¤ÏÈÈÜ»¯µÄÈÈÈܽºÍ¨¹ýѹÁ¦¹õѹµÄ·½Ê½×ªÒƵ½»ù²ÄÉÏ£¬£¬£¬¶øºóºæ¸ÉÄý¹Ì¡£

Ò½ÓÃÒ½ÁÆÆ÷еÃð¾úÏû¶¾Ö½ËÜ°ü×°´ü–¸ù»ùÇкÏÐÔÉêÃ÷

ISO13485Ò½ÁÆÆ÷еÖÊÁ¿ÏµÍ³“ÇкÏÐÔÈÏÖ¤”£»£»

ISO11607-1×ÊÁÏ¡¢ÎÞ¾ú·®ÀéϵͳºÍ°üװϵͳµÄ“ÇкÏÐÔÖ¤Ã÷”£»£»

ISO11607-2 ³ÉÐΡ¢ÃÜ·âºÍ×°Åä¹ý³ÌµÄ“ÓÐЧÐÔÈ·ÈÏÖ¤Ã÷”£»£»

EN868-2¡«10´ýÃð¾úÒ½ÁÆÆ÷е°ü×°×ÊÁϺÍϵͳ“Óйز¿ÃŵÄÑéÖ¤Ö¤Ã÷”£»£»

ISO10993Ò½ÁÆÆ÷еµÄÉúÎïÆÀ¶¨µÄ“°²È«ÐÔÖ¤Ã÷”£»£»

94/62/EC°ü×°ºÍ°ü×°·ÏÁÏÖ¸Áî“ÇкÏÐÔÖ¤Ã÷”£»£»

ISO11140Ò½ÁƲúÆ·Ãð¾ú¡¡»¯Ñ§ÅúʾÎïµÄ“ÇкÏÐÔÖ¤Ã÷”£»£»

FDA 510K¡¡×¢²áÖ¤Ã÷£»£»

ISO Class 8£¬£¬£¬GMP 10Íò¼¶¾»»¯³µ¼ä“ÇкÏÐÔÖ¤Ã÷”¡£

Ò½ÁÆÆ÷еÃð¾ú°ü×°´üÖÐһЩÓÐЧµÄÉè¼Æ²½Öè

ÕâЩÉè¼Æ²½Öè¾ùÀ´×Ôʵ¼Ê£¬£¬£¬²¢ÇÒÒѾ­±»Ö¤Ã÷ÊÇÇÐʵÓÐЧµÄÄÜΪҽÁÆÆ÷еÃð¾ú°ü×°Éè¼Æ´øÀ´¼ÛÖµµÄһЩ˼Ï뷽ʽºÍʵ¼Ê²Ù×÷²½Ö裬£¬£¬µ±È»ÕâЩ²½Ö趼ÒѾ­µÃµ½ÁËÈϿɲ¢Ð´½øÁËISO 11607ÀïÃæ×÷Ϊ³ß¶ÈµÄÒ»²¿ÃŹ©Òµ½ç²Î¿¼¡£

×Çé¿ö£¨Worst Case£©

ÐÔÖÊÉÏÀ´Ëµ£¬£¬£¬'×Çé¿ö”Ò²¼´Ê¹ÓÿÆѧºÏÀíµÄɸѡ¼¿Á©£¬£¬£¬ÔÚ±£ÕÏÁ˾ÖÕýÈ·µÄÇ°ÌáµÄÏ£¬£¬£¬½øÐÐÖÁÉÙ´ÎÊýµÄʵ¼Ê»ò³¢ÊÔ³¢ÊÔ¡£¶øÆäÀíÂÛÖ§³Ö£¬£¬£¬ÆäʵҲ¼«¶Èµ¥Ò»£¬£¬£¬Í¨Ë×µÄ˵£¬£¬£¬¿ÉÄܾÍÊÇÈç¹ûA´óÓÚB£¬£¬£¬BÓÖ´óÓÚC£¬£¬£¬ÔòÄܹ»µÃ³öA´óÓÚCµÄ½áÂÛ¡£

'×Çé¿ö”µÄÁìÓòÄܹ»Ô̺¬ÔÚ×ö°ü×°¹¤ÒÕÑéÖ¤ºÍÃð¾ú¹¤ÒÕÑé֤ʱµÄ¸÷À๤ÒÕ²ÎÊý¼«ÏÞÖµµÄ°ÎÈ¡£¬£¬£¬¶øºó°Ñ¾­ÊܹýÕâЩ¹¤ÒÕ²ÎÊýµÄÑùÆ·È¥½øÐÐÔ¤Ô¼µÄ»úÄܳ¢ÊÔ£¬£¬£¬ÈôÊÇÕâÑùµÄÑùÆ·¶¼Äܹ»Í¨¹ýÕâЩ»úÄܳ¢ÊÔ£¬£¬£¬ÄÇôҲÄܹ»ºÏÀíµÄ´§¶ÈÄÇЩֻÊǾ­¹ýºÏÀí²ÎÊýµÄÕý³£ÑùÆ·¸üÓÐÀíÓÉͨ¹ýÔ¤ÆڵĻúÄܳ¢ÊÔ£¬£¬£¬ÕâÑù²»½öÔÚ³¢ÊÔ´ÎÊý·½ÃæÓÐËùÏ÷¼õ£¬£¬£¬¸ü¶àµÄÊÇÔÚ°²È«ÐÔ·½ÃæÓÐËùÌá¸ß¡£ '×Çé¿ö”µÄÁíÒ»ÖÖ´ó¾ÖÔòÌå´Ë¿Ì½ÓÏÂÀ´µÄ'²úÆ·¼Ò×å”Õâ¸öÄÚÈÝÀï¡£

²úÆ·¼Ò×壨Product Family£©

´ÓÐÔÖÊÉÏÀ´Ëµ£¬£¬£¬'²úÆ·¼Ò×å”ÊÇ×Çé¿ö”µÄÒ»ÖÖ²û·¢´ó¾Ö£¬£¬£¬¾ßÌ嵽ʵ¼ÊʹÓ㬣¬£¬¶Ô'²úÆ·¼Ò×å'¶øÑÔ£¬£¬£¬ºÃ±Èij¹«Ë¾¿ª·¢ÁËÒ»¸öϵÁеÄijÀàÒ½ÁÆÆ÷е²úÆ·£¬£¬£¬ËüÃÇÓÖ¶¼Ñ¡È¡Ò»ÑùµÄ°ü×°·½Ê½£¬£¬£¬ÄÇôƾ¾Ý‘²úÆ·¼Ò×å’ÕâÖÖÀíÂÛ£¬£¬£¬Äܹ»ÔÚÕâ¸öϵÁÐÖÐÕÒµ½Ò»¸ö×îÓдú±íÐԵIJúÆ·£¬£¬£¬ÕâÖÖ´ú±íÐÔÌå´Ë¿ÌÖîÈç³ß´ç×î´ó¡¢Ó²¶È×î¸ß¡¢Á㲿¼þ×î¶à»ò½á¹¹×ÔÓ¡¢²úÆ·×î´àµÈһϵÁп´ÆðÀ´ÊÇ×îÈÝÒ׳öÎÊÌâµÄ´¦Ëù£¬£¬£¬ÕâÑùÄܹ»Ï÷¼õ±ØÒª²âÊÔ²úÆ·µÄÊýÁ¿£¬£¬£¬Ï÷¼õ³¢ÊÔ´ÎÊýºÍ¹¤×÷Á¿£¬£¬£¬´Ó¶ø´ïµ½ºÏÀí½ÚÔ¼³É±¾ºÍ¹¦·òµÄÖ÷ÕÅ¡£

²»ÄÑ¿´³ö£¬£¬£¬ÔÚÒýÓÃÉÏÊö‘²úÆ·¼Ò×å’¸ÅÄîʱ£¬£¬£¬µ±Ì¸µ½ÈôºÎÑ¡Ôñ´ú±íÐÔ²úÆ·µÄʱ³½£¬£¬£¬Ò²ÌìÈ»¶øÈ»µÄ¾ÍÒýÓÃÁË‘×Çé¿ö’Õâ¸ö¸ÅÄ£¬£¬ÓÉÓÚÑ¡Ôñ³öÀ´µÄÄǸö´ú±íÐÔ²úÆ·£¬£¬£¬Ò²Í¬Ê±¾ÍÊÇÕâ¸ö‘×Çé¿ö’µÄ´ú±í£¬£¬£¬ÕâÖÖ˼ÏëÔÚ¿ª·¢ÏµÁвúƷʱÉè¼Æ°ü×°»á¼«¶ÈÓмÛÖµ¡£

º¹ÇྭÑéºÍÊý¾Ý£¨Experience and Data£©

ÎÞÂÛ´ÓÄĸö·½Ã濼Á¿£¬£¬£¬Ò½ÁÆÆ÷еÃð¾ú°ü×°¶¼ËãÊǸö¼«¶È×ÛºÏÐÔµÄѧ¿Æ£¬£¬£¬²¢ÇÒÔÚÊÀ½çÁìÓòÄÚ¶¼¼«¶ÈµÄÐÂÏÊ£¬£¬£¬ºÃ¶àÓйصÄÀíÂÛÒâʶ¶¼Ã»Óж¨ÂÛ£¬£¬£¬ÉõÖÁºÃ¶àרҵÃû³ÆµÄ³ÆºôÒ²»¹Ã»ÓкܺõĹ̶¨ºÍͳһ¡£»£»ùÓÚÕâЩÏÖʵµÄÎÊÌ⣬£¬£¬ÒÔ¼°Ò½ÁÆÐÐÒµÕýÊÓ°²È«ÐԺͽÐø²»±äÐÔµÄÌìÈ»´«Í³£¬£¬£¬²»ÑÔ¶øÓ÷µÄÊÇ£¬£¬£¬²Î¿¼º¹ÇྭÑéºÍÊý¾ÝÊǼ«¶È±ØÒªµÄ£¬£¬£¬Ò²³¤¶Ì³£¿¿µÃסµÄ¡£