GOST EN 13795-2-2011 Surgical drapes gowns and clean air suits used as medical devices for patients clinical staff and equipment Part 2 Test methods《患者和医务人员用作为医疗用具的手术帘、手术服和清洁气衣及设备 .pdf

1、 , , 2 (EN 13795-2:2004, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)EN 13795-22011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRU 4 13 2011 . 1266- EN 13795-22011 1 2013 .5 EN 13795-2:2004Surgical drapes, gown

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3、III EN 13795-22011 EN 13795 , , :- 1 ;- 2 ;- 3 . - , . EN 13795, EN ISO 22610 EN ISO 22612, , 1. , -, , .IV EN 13795-22011 , , 2 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment.Part 2. Test methods1 - , .1 , , .2 . . EN 13795-1, .2 :EN

4、13795-1:2002 Surgical drapes, gowns and clean air suits, used as medical devices, for patients,clinical staff and equipment Part 1: General requirements for manufacturers, processors and products( , , . 1. )EN 20811:1992 Textiles Determination of resistance to water penetration Hydrostatic pressuret

5、est ( . . )EN 29073-3:1992 Textiles Test methods for nonwovens Part 3: Determination of tensile strengthand elongation ( . . 3. )EN ISO 139:2005 Textiles Standard atmospheres for conditioning and testing ( -. )EN ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1:Determ

6、ination of a population of microorganisms on products ( . - . 1. )EN ISO 13938-1:1999 Textiles Bursting properties of fabrics Part 1: Hydraulic method fordetermination of bursting strength and bursting distension ( . -. 1. )EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medica

7、l devices, for patients,clinical staff and equipment Test method to determine the resistance to wet bacterial penetration (- , , - . )1 EN 13795-22011 20130101EN ISO 22612:2005 Clothing for protection against infectious agents Test method for resistance todry microbial penetration ( . - )ISO 9073-10

8、:2003 Textiles Test methods for nonwovens Part 10: Lint and other particlesgenerationinthedrystate(.10.- , )3 EN 13795-1, - :3.1 (colony forming unit CFU): , - . , , .3.2 (product): , , ( ).4 4.1 , , . .4.2 , , , EN ISO 139. .5 5.1 EN ISO 117371. EN ISO 11737-1 , - . EN ISO 11737-1 , , , . CFU/100 2

9、.5.2 ISO 9073-10.1 ISO 9073-10 ., , , - , . .2 , - :- 3 25 .3 , 3 25 :- , 30, 60 90 c, - (PM):PM = C30+C60+C90.2 EN 13795-22011 (IPM), - lg :IPM = lgPM.5.3 - ISO 9073-10. ISO 9073-10 . , , , , . , . . , 3 25 . , 3 25 -.5.4 EN 20811. , EN 20811, :a) 100 2;b) (10,0 c177 0,5) /;c) , , .5.5 - EN ISO 13938-1. EN 29073-3.1 , , .2 , .5.6 - EN 29073-3, , .5.7 , , , :) ;b) (% RO) - (% Retention), :% Retention = 10 % RO, % Retention , . . 3 4, , - .5.8 EN ISO 22612.5.9 EN ISO 22610.3 EN 13795-22011 ZA()