1、 201(,)201 -201(,)1 -,(),42 160 3 201.4 7160-05(2010)(ASTM D 7160-05(2010)Standard practice for determination of expiration dating for medical gloves,IDT).1.5-2012(3.5).,5 II -201(,)26 .(1 ),-.().,-(www.gost.ru),201 ,III 1-201(,)Medical gloves.Determination of expiration dating -201-1 1.1 .1.2 ,.,.2
2、 :2.1 1 412,.(ASTM D 412,Standard test methods for vulcanized rubber and thermoplastic elastomers-Tension)573,.(ASTM D 573,Standard test method for rubber-Deterioration in an air oven)1)ACTM ,www.astm.org :serviceastm.org.(Annual Book of ASTM Standards).,1 -201(,)3078,(ASTM D 3078,Standard test meth
3、od for determination of leaks in flexible packaging by bubble emission)3577,(ASTM D 3577,Standard specification for rubber surgical gloves)3578,(ASTM D 3578,Standard specification for rubber examination gloves)5151,(ASTM D 5151,Standard test method for detection of holes in medical gloves)5250,(ASTM
4、 D 5250,Standard specification for poly(vinyl chloride)gloves for medical application)6319,(ASTM D 6319,Standard specification for nitrile examination gloves for medical application)7161,(ASTM D 7161,Standard practice for determination of real time expiration dating of mature medical gloves stored u
5、nder typical warehouse conditions)88,(ASTM F 88,Standard test method for seal strength of flexible barrier materials)1929,(ASTM F 1929,Standard test method for detecting seal leaks in porous medical packaging by dye penetration)1980,(ASTM F 1980,Standard guide for accelerated aging of sterile barrie
6、r systems for medical devices)2.2 (ISO)2)2859,(ISO 2859,Sampling procedures and tables for inspection by attributes)4074,.(ISO 4074,Natural latex rubber condoms-Requirements and test methods)2)(ISO),1,ch.De la Voie-Creuse,Case postale 56,CH-1211,Geneva 20,Switzerland,http:/www.iso.ch.23 3.1 :3.1.1 (
7、accelerated aging):.3.1.2 (date of manufacture):.3.1.3 (real time aging):,.,.3.1.4 (real time expiration date):,.3.1.5 (shelf life):(),.,.3.1.6 (time zero):.4 4.1 -,/.,.4.2 ,.1980 ,.-201(,)3 -201(,)4.3 ,7161.5 5.1 .6 6.1 ,ACTM ,.6.2 ,.6.2.1 6.4.6.2.2 6.5.6.2.3 6.4.6.3,.,.1.6.4 6.4.1 .,ASTM .96 .4 -2
8、01(,)6.4.2 ,1.9.1.3.1 -,(,)(72 2)()70 2(166 2)()70 2(90 1)()50 26.4.3 7.16 96 573.6.5 6.5.1 ,.6.5.2 ,.25.24 .6.5.3 7.6.5.4 ,.5 -201(,)7 7.1 2 .2-5151 -2859,S-3,32.AQL=1,50 AQL=2,50 412 -2859,S-3,32.(3577,3578,5250,6319 .).AQL=4,00 -3078 -2859,S-4,50.AQL=0,65 AQL=1,50 -1929:2859,S-4,50.AQL=0,65 AQL=1
9、,50 -88:2859,S-4,50.AQL=0,65 AQL=1,50 6 -201(,)8 ,8.1 ,50 C,.8.2 ,(50 2)C,.8.3 25%,.,.1 -.8.4 ().9 9.1 9.1.1 .9.1.2 .9.1.3 6.4.2 .4074,K .,2.,A3.,-7 -201(,).,.9.2 .,.(),.8 -201(,)1()1.1.1.1-9 2()A2.1 A2.1.1 ,83/,(.4074,K ).,83/.,.,().A2.1.2 (-7.1).,50 70 C.80.5.2.1-75%.2.2 2.2.1 k -201(,)10 -201(,)k
10、=A e*aRT(2.1)A-,;Ea -;R-(R=8,314 103 );-T-,.2.2.2 ,_ k2a =ki k2-2;k1 -1 (1 2).2.2.3 (2.1)(2.2),(2.2)a=eR l Ti T2(2.3)2.2.4 a i 12(2.4)Ea I 1 1 t1 -1 ;t2-2 (1 2).2.3 A2.3.1 (50 60 C,60 C 70 C,70 C 80 C)(A2.4).A2.3.2 ,A2.3.1,(2.3).83/.(2/),83/.4074,.A2.4.11 -201(,)A2.3.3 ,Tstorage(Tstorage=30)(A2.3),-
11、Tstorage;2-;-,A2.3.2 .A2.4.2.4 A2.4.1 tstorage Tstorage(Tstorage=30 C)(A2.4),t1 -tstorage;t2-;-,A2.3.2 A2.3.3.tstorage .12 1-201(,)3()A3.1 A3.1.1 .().(.A3.1),.3.1-3.1.2 50 C,60 C,70 C,80 C 90 C().,.-13 -201(,).,.3.2 3.2.1 ,(.A3.1).3.2.2 (.3.1).,.,R 0,90,(.3.2).,.(.A3.3).A3.3 A3.3.1 412.A3.4 3.4.1 ,.
12、,.14 1-201(,)1 -;2-;3-;4-3.2-.1 -S;2-;3-3.3-15 -201(,)A3.5 A3.5.1 412.N .A3.5.1.1 ,.A3.5.1.2 b,-/.A3.5.1.3 .A3.5.2 N N=b c+a.(A3.1)A3.5.3 .N=.,.A3.6 A3.6.1 .,.A3.6.2 ,.,8-10.,.-3.1.16 -201(,)3.1-,302 4 8 7142842567016880XXXXX70XXXXX60XXXXX50XXXXXA3.7 A3.7.1 ,.A3.8 A3.8.1 .A3.8.2 .A3.8.3 .A3.8.4 (.3.
13、2).A3.1-,.A3.8.5 ;,.,(.A3.3).A3.9 A3.9.1 ,17 ,.,30 -40 .,.,.-201(,)18()()-201(,).1 ()412MOD 54553-2011 .573-*3078 3577IDT -201 .3578IDT -201 .5151IDT 33076-2014 .5250IDT -201 .6319IDT 32337-2013 .7161-*88-*1929-*1980-*2859-1IDT 2859-1-2007 .1.2859-2MOD 50779.72-99(2859-2:85).2.LQ19 .1 -201(,)()2859-3IDT 2859-3-2009 .3.2859-4IDT 2859-4-2006 .4.2859-5IDT 2859-5-2009 .5.AQL 2859-10IDT 2859-10-2008 .10.2859 4074-*.-:IDT-;MOD-.20 615.479.47:006.354 83.140.01:,-201(,).14.14.21