1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 32336 2013 2014 32336 2013 II , - 1.092 . - 1.22009 . -, . , -, , 1 - ( - ), - 160 , 4 2 3 , ( 60- 18 2013 .) : ( 3166) 00497 ( 3166) 00497 - AZ AM BY KG MD - RU TJ UZ 4 ASTM D 632408 Standard test method for male condom
2、s made from polyurethane ( -)11). ASTM D11 - . (en). . 1.52001 ( 3.6). ASTM, - , ASTM , , . (IDT). 5 22 - 2013 . 761- 323362013 - 1 2015 . 6 1 1 2008 . 2008 . - 1999 . 2005 32336 2013 III - , . () - - . , , 2014 , 32336 2013 1 Mechanical contraceptives. Condoms made from polyurethane. Test methods 2
3、015 01 01 1 1.1 -, , -. . 1.2 - . - . 1.3 , , . 1.4 . 1.5 . - . 1.6 -, . - , - . 2 . , - ( ). ASTM D 37404 Test methods for thickness of solid electrical insulation ( ) ASTM D 61808 Practice for conditioning plastics for testing ( - ) ASTM D 63810 Test method for tensile properties of plastics ( ) A
4、STM D 88210 Test method for tensile properties of thin plastic sheeting ( ) ASTM D 307808 Test method for determination of leaks in flexible packaging by bubble emission ( - ) ASTM D 376708 Practice for rubber Measurement of dimensions (. -) ANSI/ASQC Z1.4 Sampling procedures and tables for inspecti
5、on by attributes ( ) 32336 2013 2 ISO 37:2011 Rubber vulcanized or thermoplastic Determination of tensile stress-strain ( . ) ISO 10993 (all parts) Biological evaluation of medical device ( ) Properties preclinical and clinical requirements for approval to market non-latex condoms. World health orga
6、nization, 1997 ( - , , 1997) - , 1 , - . (), - () . , , , , . 3 3.1 . - . 3.2 , . 4 4.1 . 4.2 , , - ISO 10993 . , , , 9, . 5 5.1 5.1.1 . . 1. 1 A) - (AQL) , S-2 4,0 160 , S-2 4,0 2 - , - G1 0,25 . 2), , S2 15 35 50 S-3 2,5 - 5.1.2 . , , , ( ). 32336 2013 3 5.1.3 . . . 5.1.4 . , , , -, - , , - , - .
7、500000 . 5.1.5 . . 5.2 , (AQL) 1. 5.2.1 . 5.2.1.1 1 1 . 5.3 , (AQL) 1. 5.3.1 . 0,5 2, 30 . 5.4 5.4.1 . , , 4, (-, , . .), , 25 . (AQL) 1. 5.4.2 . , . 5.5 5.5.1 - . - 2. . 5.5.2 - , . 5.5.2.1 675%. 5.5.2.2 675% 500%. 5.5.2.3 500%. 2 , . 5.6 5.6.1 , . 5.6.2 ASTM D 3078 - 50 (300 . . 15 . .). - (AQL) 1. 32336 2013 4 5.7 - . , , () . - , , 4 - . 6 6.1 . 6.1.1 6.1.1.1 1 , , 16 , : (30 5) , (90 5) (150 5) -, . 6.1.1.2 . 6.2 , . 6.2.1 2. 6.2.2 . 6.3 -. 6.3.1 2. 6.3.2 - . 6.4 . 6.4.1 3. 6.4.2 -. 7 7.1
