GOST ISO 29941-2013 Mechanical contraceptives Natural rubber latex condoms Determination of nitrosamines content《机械性避孕法 天然橡胶乳胶避孕套 亚硝胺含量的测定》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) ISO 29941 2013 (ISO 29941:2010, IDT) 2014 ISO 299412013 II , 1.092 . 1.22009 . , . , , , 1 - ( ), 160 , 4 2 3 , ( 28 2013 . 58-) : ( 3166) 00497 ( 3166) 00497 AZ AM BY KG MD RU TJ UZ - 4 ISO 29941:2010 Condoms Determinat

2、ion of nitrosamines migrating from natural rubber latex condoms (. , ). ISO/TC 157 , (ISO). (en). . 1.5 ( 3.6). (IDT) 5 28 2013 . 760- ISO 299412013 1 2015 . 6 ISO 299412013 III , . () . , , 2014 , ISO 299412013 1 Mechanical contraceptives. Natural rubber latex condoms. Determination of nitrosamines

3、 content 20150101 1 N-, . , , , , . 2 . . ISO 3696:1987 Water for analytical laboratory use Specification and test methods ( . ) ISO 4074:2002, Natural rubber latex condoms Requirements and test methods ( . ) ISO/IEC 17025:2005, cor. 1:2006, General requirements for the competence of testing and cal

4、ibration laboratories ( , 1) 3 : 3.1 (condom): , , . , , . . . 4 N- . . N- . N- N- -, . N-. N- . 5 N- , . , ISO 299412013 2 5 . , . 3 ISO 3696. 5.1 , N-. 5.2 1 2/, 3000 8000 150 650 . 1 200 , . , . 5.3 -. 5.4 (NaOH)=1 /3. 5.5 99,996% . 5.6 . 5.7 (6.3 6.4). 5.8 . 5.9 N-. N- - (5.3) 100 300 /3. N- ( )

5、: - N- (NDMA); - N- (NDA); - N- (NDA). N-, , N-, N-, : - N- (NDBzA); - N- (NDiNA), N-3,3,5-. 5.10 N- (NDiA) 200 /3 (5.8). N-. 5.11 . 30 25 3 (5.1). 5.12 (NH3)=0,1/3. 5.13 , . 6 , . 6.1 , , (5.12), . 6.2 , (40 2) . 6.3 (300 10) , (26 1) . 6.4 (300 10) , (15 1) . 6.5 -, . -. 6.6 , 40 60 . 6.7 , N-, ,

6、. 6.8 . 6.9 , . 6.10 200 3. 6.11 100 3. ISO 299412013 3 6.12 - 1). . 6.13 . , , : - N-, 5.9 , (5.10); - N- N- N-. N- N- . N- . 1 . 200 . 200 . 2,5 3,0 , 1/8 , : - 15% Carbowax 20 M, Chromosorb WHP 100/120 2); - 10% Carbowax 20 M, 2 % Chromosorb WHP 100/120 . 4,0 5,0 , 1/8 , 15% SP 1220, 1% H3PO4 Chr

7、omosorb WAW 100/120 . 480 . -: , (20 1) 3/. , 250 . -N- : - 150 ; - 120 130 . 2 , 1/4 , 2,0 , : - 10% OV-101 Chromosorb WHP 80/100 ; - 3% OV-225 Chromosorb WHP 80/100 . 480 . 250 . 2 200 . 60 , 230 (10 /). 25,0 , 0,53 FFAP 1 . 480 . 250 50 , 1 200 (75 /). 40 , 7 60 (1 /), 230 (14 /). 30,0 , 0,53 , S

8、E-542 . 480 . 250 . 1) . , ISO. 2) Carbowax Chromosorb . , ISO. ISO 299412013 4 7 7.1 N- 7.1.1 , ISO 4074. (. 8) . . . . (5 1) 0,05 50 3. 40,0 3 . , , . 10 30 (40 2) . 5 , . (5.10) 1,0 3. 7.1.2 50 3 , 4,0 3 , , 1 . 7.2 N- 7.2.1 , , 1,0 3 1,0 3 . . 7.2.2 7.2.2.1 26 , (6.9), (25,0 0,1) (5.2). (5.7) 1 (5.13). . 7.2.2.2. (7.2.1) . . 10 15 . 50 70 . 7.2.2.3 60 80 3 , 40 3 - (6.5) 1525