GOST EN 13795-3-2011 Surgical drapes gowns and clean air suits used as medical devices for patients clinical staff and equipment Part 3 Performance requirements and performance lev.pdf

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1、 , , 3 (EN 13795-3:2006, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)EN 13795-32011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRU 4 13 2011 . 1267- EN 13795-32011 1 2013 .5 EN 13795-3:2006Surgical drapes, gown

2、s and clean air suits, used as medical devices, for patients, clinical staff andequipment Part 3: Performance requirements and performance levels ( , , . 3. ). (IDT). - . 13795-320086 ( ) - . , - . - C, 2013 -, II EN 13795-320111 .12 13 14 .2ZA() 93/42/ .4() .5 6III EN 13795-32011 EN 13795 , , :- 1

3、;- 2 ;- 3 . - , . , - - . EN 13795, 1 2, , - 93/42/. , , .IV EN 13795-32011 , , 3 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment.Part 3. Performance requirements and performance levels1 , - . -13EN13795-1EN13795-2,12.2 :EN 13795-1:2002

4、 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 13795-2:2004 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinic

5、alstaff and equipment Part 2: Test methods ( , , . 2. )3 :3.1 (less critical product area): , .1 . EN 13795-1.2 , EN 13795-1 , , (. EN 13795-1).3.2 (performance level): 4 . EN 13795 , , .3.2.1 (standard performance): , - (. 4), .1 EN 13795-32011 201301013.2.2 (high performance): , , - . , - , , -, .

6、3.3 (product): , , ( ).4 EN 13795 , - 13, EN 13795-2.1 , , - , , EN 13795-1.2 EN 13795-2, 1 2.3 . . 1 - - - - Lg(CFU) -c163 2a), c) c163 2a), c) - BIc179 2,8b) -6,0b), d) Lg(CFU/2)15 15 20 20 c179 15 -c179 20 -a) : 108CF/ talc. 30 .b) (LSD) BI, 1, 0,98 95 %- . , , - . , , 0,98 BI, , - ; , 0,98 BI, ,

7、 (95 %- , () 19 20 , ).c) Lg CFU c163 2 300 CFU.d)BI = 6,0 : . BI = 6,0 . 3 b) Lg (CFU)c163 2a), c) Lg (CFU/2)c) IPM 3,5-, Lg ( ) 4,0 c179 40 c179 20a) : 108CF/ talc. 30 .b) , . . , .c) Lg CFU c163 2 300 CFU.3 EN 13795-32011 ZA() 93/42/ , CEN , - 93/42/. () 93/42/ , , , , - ZA, 93/42/ - (EFTA). ZA.1

8、 93/42/ 93/42/4 1, 2, 3, 4, 7.2, 7.5, 7.6, 8.1 - EN 13795-1 EN 13795-2 , - .4 EN 13795-32011 (c) .1 EN 13795-1:2002 , - , - . 1. IDT EN 13795-12011 , - , - . 1. EN 13795-2:2004 , - , - . 2. IDT EN 13795-22011 , - , - . 2. - :- IDT .5 EN 13795-320111 ISO 22610:2006 Surgical drapes, gowns and clean ai

9、r suits, used as medical devices, for patients, clinical staffand equipment Test method to determine the resistance to wet microbial penetration( , , . - )2 ISO 22612:2005 Clothing for protection against infectious agent Test method for resistance to dry microbialpenetration( . )6 EN 13795-32011 613.48:006.354 11.140 38 IDT : , , , - , , 7 EN 13795-32011 . . . . 28.05.2013. 14.06.2013. 60c1808418. . . . 1,40. .-. . 0,75. 61 . . 619. , 123995 , ., 4.www.gostinfo.ru infogostinfo.ru . . , 105062 , ., 6.