1. FDA浠嬬垂锛�
缇庡湅椋熷搧鍜岃棩鍝佺鐞嗗眬锛�FDA锛夎矤璨�(z茅)鐩�(ji膩n)绠￠鍝佹帴瑙告潗鏂�锛屾椤炴潗鏂欏繀闋堢稉(j墨ng)閬庢娓紝纰轰繚閬斿埌椋熷搧鎺ヨЦ瀹夊叏妯�(bi膩o)婧�(zh菙n)銆傜編鍦嬭伅(li谩n)閭︽硶瑕�(gu墨)锛�CFR锛夌21绔犲皪姝ら鏉愭枡浣滃嚭鍏烽珨瑕�(gu墨)瀹氾紝骞跺皣姝ら鏉愭枡瑕栫偤“闁撴帴椋熷搧娣诲姞鍔�”銆�
2. 缇庡湅椋熷搧鍜岃棩鍝佺鐞嗗眬锛�FDA锛夊垪鍑轰笁椤為鍝佹坊鍔犲姂锛�
|
椤� 鍨�
|
瑾� 鏄�
|
|
1)鐩存帴椋熷搧娣诲姞鍔�
|
鐩存帴鍔犲叆椋熷搧涓殑鎴愬垎
|
|
2)浜岀礆鐩存帴椋熷搧娣诲姞鍔�
|
鍦ㄩ鍝佽檿鐞嗛亷绋嬩腑鍔犲叆椋熷搧鐨勬垚鍒嗭紝渚嬪锛岀敤闆㈠瓙妯硅剛銆佹憾瑙ｈ悆鍙栬檿鐞嗛鍝�
|
|
3)闁撴帴椋熷搧娣诲姞鍔�
|
鍙兘浣滅偤鍖呰鎴栧姞宸ヨō(sh猫)鍌欑祫鎴愰儴鍒嗚垏椋熷搧鎺ヨЦ鐨勭墿璩�(zh矛)锛屼絾骞堕潪鐩存帴鍔犲叆椋熷搧涔嬩腑
|
*鍌欐敞锛氬儏“闁撴帴椋熷搧娣诲姞鍔戯紓鑸囬鍝佹帴瑙告潗鏂欑浉闂�(gu膩n)
3. 鑸囬鍝佹帴瑙告潗鏂�FDA 娓│闋呯洰锛�
缇庡湅鑱�(li谩n)閭︽硶瑕�(gu墨)锛�CFR锛変綔鍑鸿姹傜殑椋熷搧鎺ヨЦ鏉愭枡锛�21 CFR 绗� 174-190 绡€(ji茅)銆傞噸瑕佺珷绡€(ji茅)鍖呮嫭锛�
· 21 CFR 绗� 175 绡€(ji茅) 闁撴帴椋熷搧娣诲姞鍔戯細娑傚堡鐨勬坊鍔犲姂鍜屾垚鍒�
· 21 CFR 绗� 176 绡€(ji茅) 闁撴帴椋熷搧娣诲姞鍔戯細绱欏嫉鍜岀礄鏉挎垚鍒�
· 21 CFR 绗� 177 绡€(ji茅) 闁撴帴椋熷搧娣诲姞鍔戯細鑱氬悎鐗╋紙濉戞枡锛�
|
No
|
鏉� 鏂�
|
妯�(bi膩o) 婧�(zh菙n)
|
|
1.
|
鏈夋娑傚堡, 閲戝爆鍜岄浕閸嶅埗鍝�
|
FDA 21 CFR绗� 175.300.绡€(ji茅)
|
|
2.
|
绱欏埗鍝�
|
FDA 21 CFR 绗�176.170绡€(ji茅)
|
|
3.
|
鏈ㄦ潗
|
FDA 21 CFR 绗�178.3800
|
|
4.
|
ABS
|
FDA 21 CFR 绗�181.32 or 180.22绡€(ji茅)
|
|
5.
|
涓欑儻閰告ü鑴傦紙Acrylic锛�
|
FDA 21 CFR 绗�177.1010绡€(ji茅)
|
|
6.
|
椋熷搧瀹瑰櫒鐨勫瘑灏佸湀锛屽瘑灏佽ク澧�
|
FDA 21 CFR 绗�177.1210绡€(ji茅)
|
|
7.
|
EVA
|
FDA 21 CFR 绗�177.1350绡€(ji茅)
|
|
8.
|
涓夎仛姘版皑妯硅剛(瀵嗚兒)
|
FDA 21 CFR 绗�177.1460绡€(ji茅)
|
|
9.
|
灏奸緧濉戞枡
|
FDA 2 1 CFR 绗�177.1500绡€(ji茅)
|
|
10.
|
PP
|
FDA 21 CFR 绗�177.1520绡€(ji茅)
|
|
11.
|
PE,OP
|
FDA 21 CFR 绗�177.1520绡€(ji茅)
|