1、 ,()INTERSTATE COUNCIL FOR STANDARDIZATION,METROLOGY AND CERTIFICATION(ISC)32336 2013 2014 323362013 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 condoms made from polyurethane(-)11).ASTM
2、D11 -.(en).1.52001(3.6).ASTM,-,ASTM ,.(IDT).5 22-2013.761-323362013 -1 2015.6 1 1 2008.2008.-1999.2005 323362013 III -,.()-.,2014 ,323362013 1 Mechanical contraceptives.Condoms made from polyurethane.Test methods 20150101 1 1.1 -,-.1.2 -.-.1.3 ,.1.4 .1.5 .-.1.6 -,.-,-.2 .,-().ASTM D 37404 Test metho
3、ds 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()ASTM D 88210 Test method for tensile properties of thin plastic sheeting()ASTM D 307808 Test method for determination of leaks i
4、n flexible packaging by bubble emission(-)ASTM D 376708 Practice for rubber Measurement of dimensions(.-)ANSI/ASQC Z1.4 Sampling procedures and tables for inspection by attributes()323362013 2 ISO 37:2011 Rubber vulcanized or thermoplastic Determination of tensile stress-strain(.)ISO 10993(all parts
5、)Biological evaluation of medical device()Properties preclinical and clinical requirements for approval to market non-latex condoms.World health organization,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 3
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7、23362013 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 .,-5.5.2.7.2 .7.3 -.8 8.1 ,.8.2 .323362013 5 ()1 1.1 1.1.1 .1.2 1.2.1 (.1.1),.1.3 1.3.1 1 ,1.1,.1.1 1.4 1.4.1 ,.-.1.4.2 20 -323362013 6,.,-.1.
8、4.3 ,.,1.1.5 1.5.1 .1.5.1.1 ,.1.5.1.2,1.4.3.1.5.1.3 .1.6 1.6.1,.2 -2.1 2.1.1 -.-.2.2 2.2.2 -.2.3 2.3.1 ,2%.2.3.2 ASTM D 412,C,DIN 53504,S3A ISO 37,3.2.3.3,.2.3.4 ,0,001 ASTM D 374 .2.3.5 ().2.3.6 (23 2)(73,4 3,6)F (50 5)%16 ASTM D 618.(23 2)(73,4 3,6)F (50 5)%.2.4 2.4.1 ASTM D 882.A2.4.2 DIN 53505,S
9、3A ISO 37,3 45 10.2.5 2.5.1 ,.-,.,-,.,.2.5.2 .2.5.3 0,001 :.2.5.4 ,.,.2.5.5 ,-.323362013 7.2.5.6 .2.5.7 ,.2.6 2.6.1 ,.(-).2.6.2 ,-100.2.7 2.7.1 .2.7.1.1.2.7.1.2 .2.7.1.3 -.2.7.1.4 .2.7.1.5 .2.7.1.6 .2.7.1.7 .2.7.1.8 .2.7.1.9 .2.7.1.10 .2.7.1.11 .3 3.1 3.1.1 .3.2 3.2.1 ,.3.3 3.3.1 0,5.3.4 3.4.1 ,.-.3
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11、,5.4.1.323362013 9 ()1 1.1 1.1.1 .1.2 1.2.1 ,-.1.3 1.3.1 0,001,ASTM D 3767,.1.4 1.4.1 ,.-.1.4.2.20 .,-.1.4.3 0,01.1.5 1.5.1 .1.5.1.1 ,.1.5.1.2,1.4.3.1.5.1.3 ,.1.5.1.4 .1.6 1.6.1 .2 2.1 2.1.1 ,.-,.,.2.1.2 ,-.2.2 2.2.1 ,-.2.3 2.3.1,0,2 3 0,05.2.3.2 ,.-,-()(150 3).323362013 10 .2.4 2.4.1 ,.-,.2.4.2 400
12、500 3/.-.2.4.3 .2.4.4 -,1,0 3,0,1.2.5 2.5.1 .2.5.1.1 .2.5.1.2 .2.5.1.3 .2.5.1.4 ,-().3 3.1 3.1.1 .3.2 3.2.1 ,-2%.3.2.2 2070.3.2.3 20,(15 1).3.2.4 ().3.2.5 40 ASTM D 618()(23 2)(73,4 3,6)F (50 5)%.:(23 2)(73,4 3,6)F (50 5)%.3.3 3.3.1 ASTM D 638.3.4 3.4.1 (20,0 0,1)70 -80 .,-.3.4.2 100 -,ASTM D 638.20
13、 (15 1).610.3.4.3 ,-.3.4.4 .3.5 3.5.1 .3.5.1.1 .3.5.1.2 .3.5.1.3 ().323362013 11 3.5.1.4 ().3.5.1.5 .3.5.1.6 .4 4.1 4.1.1 -.,-.4.2 4.2.1 ,.4.2.2 -.4.3 4.3.1 ,.1.1 -(FDA),5600 Fishers Ln.,Rockville,MD 20857.323362013 .()ASTM -.1 -ASTM D 37404 *ASTM D 61808 -*ASTM D 63810 *ASTM D 88210 *ASTM D 307808 -*ASTM D 376908.-ISO 37:2011 -.IDT ISO 372013 .ISO 10993 *ANSI/ASQC Z1.42003 *.-.-.-:IDT 615.477.86:006.354 84.140 IDT :,-,01.09.2014.60 x841/8.1,86.35.3407 ,123995,.,4.www.gostinfo.ru infogostinfo.ru
