KS K ISO 22612-2012 Clothing for protection against infectious agents－Test method for resistance to dry microbial penetration《防止传染介质的防护服装 抗干微生物穿透性的试验方法》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS K ISO 22612 KS K ISO 22612:2012 2012 12 28 http:/www.kats.go.krKS K ISO 22612:2012 : ( ) ( ) FITI PIO ( ) : (http:/www.standard.go.kr) ： ：2007 10 04 ：2012 12 28 2012-0822 ： ： ( 02-509-7278) (http:/www.kats.go.kr). 10 5 , . KS K ISO 22612:2012 i ii . iii 1

2、 1 2 1 3 .1 4 1 5 2 6 2 6.1 2 6.2 .2 6.3 .2 7 3 8 .4 A( ) TGE .7 A.1 .7 A.2 7 8 KS K ISO 22612:2012 ii . KS K ISO 22612： 2007 . . , , . , , . KS K ISO 22612:2012 iii 2005 1 ISO 22612, Clothing for protection against infectious agents Test method for resistance to dry microbial penetration , . KS K I

3、SO 22612:2012 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration 1 . , EU Directive 93/42/EEC . 2 . . ( ) . EN 13795 1:2002, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment Part 1： G

4、eneral requirements for manufacturers, processors and products 3 EN 13795 1:2002 . 4 . 1 (Bacillus subtilis) . 1 . . . . . . 2 2 2 . , EN 13795 3 . KS K ISO 22612:2012 2 5 (202) C, (655) % . 6 6.1 1 6.1.1 10 mm , 40 cm40 cm (： ) , 4 . 6.1.2 650 N , 20 800 1)6.1.3 . 6.1.4 20 800 . 6.1.5 6 6.1.6 6 , .

5、 6.1.7 6.2 2 6.2.1 . 10 mm . 6.2.2 . 6.2.3 , . 6.2.4 , . 6.2.5 TGE 9 cm ( A ). 6.3 6.3.1 1) , K13 ERKALAITE OY . , CEN .KS K ISO 22612:2012 3 6.3.1.1 (500.5) g (95 % 15 m)2)6.3.1.2 109/mL ATCC 9372 3)6.3.1.3 TGE 6.3.2 6.3.2.1 50 g . 160 C 210+ . 6.3.2.2 5 mL . 6.3.2.3 50 (50 L100 L) . 6.3.2.4 , . 6.

6、3.2.5 , silica gel 2 3 . 6.3.2.6 . 6.3.2.7 35 C TGE (bioburden) cfu/g (3 2 ). 6.3.2.8 104cfu/g 108cfu/g . . 7 7.1 200 mm200 mm 12 . 7.2 ( ) . 7.3 . 7.4 . 7.5 . 7.6 , . 7.7 . 7.8 (0.50.1) g (plunger orifice) 5 . 6 . 2) , FINNTALC M15 OMYA BENELUX S.A. . Place Eug. Keym 43 B 27, B-1170, Bruxelles, tel

7、.： 32 26 74 23 11, fax. 32 2672 92 68. , KS .3) , SIMICON GmbH Schuhmacherring 12, D 81737 Mnchen, fax. 49 89 67 33 66 22. , KS .KS K ISO 22612:2012 4 7.9 . 7.10 (bag) . 7.11 . 7.12 . 7.13 20 800 . 7.14 . 7.15 . 7.16 35 C 24 h . 7.17 . (6 ) 0 . , . 7.18 7.1 7.17 . 7.19 10 . 8 . a) b) , 6.3.2.8 7.13

8、c) d) e) f) (7.19 ) KS K ISO 22612:2012 5 ： mm 1 2 3 4 5 6 7 8 1 KS K ISO 22612:2012 6 ： mm 1 2 3 4 5 6 7 8 2 KS K ISO 22612:2012 7 A ( ) TGE A.1 (Beef extract) 3 g (Tryptone) 5 g Dextrose(glucose) 1 g 15 1 000 mL A.2 , 25 C HCl NaOH pH (7.00.2) . 120 C 15 min . . KS K ISO 22612:2012 8 1 EN 13795 3,

9、 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Part 3： Performance requirements and performance levels 153787 1 92 3(16) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS K ISO 22612:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Clothing for protection against infectious agentsTest method for resistance to dry microbial penetration ICS 13.340.10