GOST EN 455-2-2014 Medical gloves for single use Part 2 Method for determination of physical-mechanical properties《一次性医用手套 第2部分 物理特性的测定方法》.pdf

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1、 2 - (EN 455-2:2009, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)EN 455-22014, - 1.092 . 1.22009 . -, . , , 1 - , , ( ), 160 - , 52 (-)3 , (- 14 2014 . 72-) : ( 3166) 00497 ( 3166) 00497 MBYKZKGMDRUTJ -4 19 2015 . 375- EN 455-22014 1 2016 .5 EN 455-2:2009 Medical

2、gloves for single use Part 2: Requirements and testing for physical properties ( . 2. ). CEN/TC 205 CEN. (en). - 1.52001 ( 3.6). , - , , , . . (IDT)6 II EN 455-22014 -, - . () . , - - , 2015 -, III EN 455-22014 2 - Medical gloves for single use. Part 2. Methods for determination of physico-mechanica

3、l properties1 1.1 (, / ) - , , . . -, . 500000 .2 . - , ( ).IS 188 Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance tests ( . )EN 455-4:2009 Medical gloves for single use Part 4: Requirements and testing for shelf lifedetermination ( . 4. )IS 23529:2004* Rubber General proc

4、edures for preparing and conditioning test pieces for physicaltest methods (. )3 :3.1 (medical gloves for single use): , - -.3.2 (surgical gloves): , , , .* ISO 23529:2010.1 EN 455-22014 201607013.3 / (examination gloves/procedure gloves): , , , .3.4 (lot): , , , , - , , - , (. EN 455-4).4 4.1 4.2 4

5、.3 13 . - 1 2. 1 ), , b), c),5 250 67 c177 45,5 250 72 c177 46 260 77 c177 56,5 260 83 c177 57 270 89 c177 57,5 270 95 c177 58 270 102 c177 68,5 280 108 c177 69 280 114 c177 69,5 280 121 c177 6) l 1.b) w 1.c) . . 2 / ), , b), c), 240c163 80 80 c177 10 95 c177 10 110 c177 10 c179 110) l 1.b) w 1.c) .

6、 . , 1.2 EN 455-220144.2 ( l 1), ,- . , . . , .4.3 ( w 1), , 1 , .5 5.1 . .- .3 EN 455-22014w ; l 1 5.2 (23c1772) - (50 c1775) % , 3. 3 , /a) b) c) d) e) 5.2 12 5.3 c179 9,0 c179 9,0 c179 6,0 c179 6,0 c179 3,6) .b) , , , , -, .c) , , , , , -, .d) .) (, , ).5.2 5.2.1 EN 455-4.5.2.2 13 ( 7 ) , , -, ,

7、2, - .5.2.3 13 16 . - , ; 500 /. , .5.2.4 ) tf 5.2.2 (13 c1773) , ISO 23529 ,(22c1775).- .b) tx ISO 23529, -5.2.4).c) tf tx.tf/txc1790,9, . tf/tx 0,9, (. 5.2.3) tf/tx. , - , - , , , - . , 3, . ( 10 %), . 10 %, - .5.2.5 () 13 - 5.2.4. , 3.4 EN 455-220145.3 5.3.1 , , (70 c177 2) 7 - ISO 188.5.3.2 5.2.6 :) ;b) ;c) , ;d) ;e) .5 EN 455-220141 6 /; 2 ; 3 2 ZA() , 93/42/EEC. . ZA.l , 93/42/EEC. - EFTA. ZA.1 93/42/EEC/ 93/42/EEC4 1,3,5,9.25 1,3,4,9.25.2 9.2 , , ZA.2 , 93/42/EEC, - 89/686/EC . ZA.2 OJEU 93/42/EEC, . ZA.2 89/686/EC ( 1(6) , - 93/42/EEC)/ 93/42/EEC4 1.1.15 1.3.25.2 2.4

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