1、 , , 1 (EN 13795-1:2002, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)EN 13795-12011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRU 4 13 2011 . 1265- EN 13795-12011 1 2013 .5 EN 13795-1:2002Surgical drapes, gown
2、s and clean air suits, used as medical devices, for patients, clinical staff andequipment Part 1: General requirements for manufacturers, processors and products ( , , . 1. ). (IDT). 13795-120086 ( ) - . - , - . - , 2013 -, II EN 13795-120111 12 13 , .34 .45 .5 () .6 () .7 () .8 ZA () , 9 10III EN 1
3、3795-12011 EN 13795 , , :- 1 ;- 2 ;- 3 . - , . - (. ). , - - (. ). , , , , , . , , , - . 1 2, 3 4, , - 5. - , , , .IV EN 13795-12011 , , 1 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment.Part 1. General requirements 201301011 - , , - 6
4、7. - , - , , - . , 8, 9, , . (- ), . - 10.2 :2.1 (clean air suit): , . - , .2.2 (cleanliness): , - . , ().2.2.1 (cleanliness microbial): , / 2 . .1 EN 13795-12011 2.2.2 (cleanliness particulate matter): , , - , 2 .2.3 (critical product area): , - , , .2.4 (drapeability): .2.5 (fabric): , , / .2.6 (f
5、ixation): . . .2.7 (infective agent): , - -.2.8 (linting): - . .2.9 (manufacturer): , , , , . 5.2.10 (processor): , - , . , , .2.11 (resistance to liquid penetration): ().2.12 (resistance to microbial penetration): - .2.12.1 (dry penetration): - () - .2.12.2 (wet penetration): - , -.2.13 (reusable p
6、roduct): , - .2.14 (single-use product): , - -.2.15 (surgical drape): , - , .2.16 (surgical gown): , - , , .2.17 (surgical procedure): , - -.2 EN 13795-120112.17.1 (clean operation): , - , , - .2.17.2 (infection-prone operation): , , .2.17.3 (invasive surgical procedure): , - .2.18 (water-vapour resistance): , - . , .3 , 3.1 , :) , - , , , -, , , ( ), ;b) , , ;) , .3.2 , :) ;b) , 13;) . 1 2 3 EN 13795-12011 2 ). 3
