寤氭埧鐢ㄥ叿缇庡湅FDA瑾嶈瓑妾㈡脯妯欐簴浠嬬垂

寤氭埧鐢ㄥ叿缇庡湅FDA瑾嶈瓑妾㈡脯妯欐簴鏈夊摢浜涳紵椋熷搧鎺ヨЦ椤炴潗鏂欐寚涓€鍒囩敤浜庡姞宸ャ€佺敓鐢€€佸寘瑁濄€佸瓨鍎插強閬嬭几椋熷搧閬庣▼涓€佽垏椋熷搧鑳藉鎺ヨЦ鍒扮殑鏉愭枡銆傚父瑕嬬殑鏉愭枡鍖呮嫭鍚勭ó濉戞枡銆侀噾灞€侀櫠鐡� 銆佺幓鐠冦€佺鏈ㄥ埗鍝佺瓑銆傞€欎簺鑸囬鍝佽兘澶犳帴瑙稿埌鐨勬潗鏂欑殑鐠颁繚瀹夊叏鎯呮硜鐩存帴浜嬮棞浣跨敤鑰呯殑椋查瀹夊叏鍜屽仴搴枫€傛墍浠ュ皪閫欓鐢㈠搧鍑哄彛鍒扮編鍦嬮渶瑕佹寜 鐓DA妯欐簴閫茶鐩搁棞鐨勬娓獚璀夈€�

銆€銆€FDA瑾嶈瓑妾㈡脯浠€涔堥儴浣嶏紵

銆€銆€鍒€鍏蜂竴鑸湁鏈ㄩ牠鎴栧鏂欏仛鐨勬墜鏌勫拰閲戝爆鍋氱殑鍒€绲勬垚锛屾墜鏌勬潗鏂欎笉闇€瑕佹娓紝妾㈡脯璺熼鍝佹帴瑙哥殑閮ㄤ綅鐨勯噾灞氨鍙互浜嗐€�

銆€銆€FDA瑾嶈瓑鎬庝箞鏀惰不锛�

銆€銆€鎸夋潗鏂欐敹璨伙紝鍍规牸1000-2000涓嶇瓑锛屽叿楂旂湅鏉愭枡锛岄潪閲戝爆鍍规牸瑕侀珮浜庨噾灞児鏍笺€�

銆€銆€涓€鍊嬬郴鍒楁湁濂藉咕鍊嬫寮忥紝鍙互涓绘脯涓€鍊嬪棊锛�

銆€銆€鏉愭枡鐩稿悓鍙互涓绘脯涓€鍊嬶紝鍏朵粬鐨勫鍦ㄩ檮鍔犲瀷铏熼噷銆�

銆€銆€FDA妾㈡脯鍫卞憡鏈夌恫绔欏彲浠ユ煡瑭㈠棊锛�

銆€銆€鍒€鍏稦DA妾㈡脯鍫卞憡娌掓湁璀夋浉锛屾墍浠ョ恫绔欐煡瑭笉浜嗭紝鍙互闆昏┍銆侀兊浠舵煡瑭€€�

銆€銆€椋熷搧鎺ヨЦ鏉愭枡FDA涓昏妾㈡脯妯欐簴渚濇摎锛�

銆€銆€1 CFR Part 177-2003锛屽嵆鑱氬悎鐗╅鐗╄唱銆�

銆€銆€21CFR Part 175-2003锛氱矘鍚堝姂鍜屾秱瑕嗘潗鏂欓銆侀噾灞锛�

銆€銆€21CFR Part 176-2003锛氱礄鍜岀礄鏉跨敘鍝�

銆€銆€21CFR Part 178-2003锛氶鍝佹坊鍔犲姂锛氬姪鍔戙€佺敓鐢㈠姪鍔戝拰娑堟瘨娈鸿弻鍔�

銆€銆€FDA CPG 7117.05 锛氶崓閵€鍒跺搧瑕佹眰

銆€銆€FDA CPG 7117.06&07鐜荤拑锛岄櫠鐡凤紝鎼摲鍣ㄧ毧瑕佹眰

銆€銆€甯歌鑸囬鍝佹帴瑙告潗鏂橣DA娓│闋呯洰濡備笅锛�

銆€銆€鏈夋娑傚堡锛� 閲戝爆鍜岄浕閸嶅埗鍝佽姹俇.S. FDA CFR 21 175.300

銆€銆€绱欏埗鍝佽姹� U.S. FDA CFR 21 176.170

銆€銆€鏈ㄦ潗瑕佹眰U.S. FDA CFR 21 178.3800

銆€銆€ABS瑕佹眰U.S. FDA CFR 21 181.32 or 180.22.

銆€銆€涓欑儻閰告ü鑴傦紙Acrylic锛夎姹俇.S. FDA CFR 21 177.1010

銆€銆€椋熷搧瀹瑰櫒鐨勫瘑灏佸湀锛屽瘑灏佽ク澧婅姹傦紝濡傜姗¤啝鍦� U.S. FDA CFR 21 177.1210

銆€銆€EVA瑕佹眰 U.S. FDA CFR 21 177.1350

銆€銆€涓夎仛姘版皑妯硅剛锛堝瘑鑳猴級瑕佹眰 U.S. FDA CFR 21 177.1460

銆€銆€灏奸緧濉戞枡瑕佹眰 U.S. FDA CFR 21 177.1500

銆€銆€PP瑕佹眰 U.S. FDA CFR 21 177.1520

銆€銆€PE锛孫P瑕佹眰 U.S. FDA CFR 21 177.1520

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