KS K ISO 16604-2012 Clothing for protection against contact with blood and body fluids-Determination of resistance of protective clothing materials to penetration by blood-borne paage《.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS K ISO 16604 Phi-X174 KS K ISO 16604:2012 2012 12 28 http:/www.kats.go.krKS K ISO 16604:2012 : ( ) ( ) 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 16604:2012 i i

2、i . iii 1 1 2 1 3 .2 4 5 5 .5 6 .5 7 7 7.1 7 7.2 8 8 8 8.1 .8 8.2 9 8.3 .10 8.4 10 8.5 (settle plate) .11 8.6 .11 8.7 .11 8.8 11 8.9 .13 8.10 .14 9 .14 A( ) 18 19 KS K ISO 16604:2012 ii . KS K ISO 16604： 2007 . . , , . , , . KS K ISO 16604:2012 iii 2004 1 ISO 16604, Clothing for protection against c

3、ontact with blood and body fluids Determination of resistance of protective clothing materials to penetration by blood-borne pathogens Test method using Phi-X174 bacteriophage , . KS K ISO 16604:2012 Phi-X174 Clothing for protection against contact with blood and body fluidsDetermination of resistan

4、ce of protective clothing materials to penetration by blood-borne pathogens Test method using Phi-X174 bacteriophage 1 . . “ / ” KS K ISO 13994 . Phi-X174 . . , . 2 . . ( ) . KS K 0541, KS K ISO 5084, KS K ISO 13994, KS K ISO 16603, KS M ISO 304, KS M ISO 3696, KS K ISO 16604:2012 2 3 . 3.1 (agar) 3

5、.2 (assay) Phi-X174 . 3.3 (assay fluid) , Phi-X174 . Phi-X174 . 3.4 (bacteriophage) Phi-X174 , . 3.5 (blood-borne pathogen) , B (HBV), C (HCV), (HIV) . . 3.6 (body fluid) ( ) , , , , ( ) , , , , , , . 3.7 (body fluid simulant) , . (0.0420.002) N/m . KS K ISO 16604:2012 3 3.8 (challenge suspension) .

6、 Phi-X174 3.9 (lawn) . Escherichia coli C.(E. coli C) . 3.10 (lysis) Phi-X174 E. coli C. . 3.11 (medium, media) . 3.12 (morphology) 3.13 (nutrient broth) , E. coli C. , Phi-X174 , , Phi-X174 . 3.14 (penetration) , , , (seam), 3.15 (plaque) , KS K ISO 16604:2012 4 Phi-X174 , E. coli C. , . 3.16 (plaq

7、ue-forming unit) PFU 3.17 (plate) 3.18 (protective clothing) . . 3.19 (surrogate microbe) Phi-X174 , HBV HIV HCV . 3.20 (titre) mL , (PFU/mL). 3.21 (virus) , . 3.22 (viral penetration) . , , , Phi-X174 3.23 (viral resistant) , “ ” KS K ISO 16604:2012 5 . 4 KS K ISO 13994 , . , . . . 5 5.1 Phi-X174(A

8、TCC 13706 B1) 1.0108PFU/mL(mL ) . , Phi-X174 , (20 ) , , , , , . Phi-X174 ( 0.027 m). 5.2 E. coli(ATCC 13706) 5.3 3 (KS M ISO 3696) 5.4 5.5 (CaCl2) 5.6 (KCl) 5.7 (NaOH) 2.5 mol/L 5.8 (polysorbate) 80 5.9 - (Bacto-agar) 6 6.1 KS K ISO 13994 , , Phi-X174 KS K ISO 16604:2012 6 . . Phi-X174 60 mL . . .

9、, , . 1 2 . 6.2 6.2.1 0.02 mm . 6.2.2 , . a) 50 % b) 5.0 mm 6.2.3 (2020) kPa . 6.2.4 (361) C . 6.2.5 (452) C . 6.2.6 0.001 g . 6.2.7 (Vortex mixer) 6.2.8 (53) C . 6.2.9 (1221) C (2147) kPa . 6.2.10 KS K ISO 16604:2012 7 6.2.11 6.2.12 pH 0.1 pH . 6.2.13 6.2.14 13.6 N m . 6.2.15 640 nm . 6.2.16 10 000

10、 g . 6.3 6.3.1 15 mm100 mm . 6.3.2 1 mL, 5 mL, 10 mL . 6.3.3 13 mm100 mm 6.3.4 6.3.5 100 mL 500 mL . 6.3.6 2 L . 7 7.1 KS K ISO 16604:2012 8 7.1.1 . . . , . , , . 70 mm , 75 mm . , , , 3 . , . KS Q ISO 2859 18 . 7.1.2 . , , . , 57 mm . , . . 7.2 (215) C, (6010) % 24 h . . 8 8.1 8.1.1 (Phi-X) . - (Ba

11、cto-tryptone) (8.00.1) g (5.00.06) g (0.20.003) g (5.3) (1 00012.5) mL (5.8) (0.10.001 25) mL pH 2.5 mol/L pH (7.31) . KS K ISO 16604:2012 9 0.1 % 1： 9 . , . 0.01 % (0.0420.002) N/m . . KS M ISO 304 . (0.0420.002) N/m . 8.1.2 (Phi-X) . - (Bacto-agar) (15.00.19) g (8.00.1) g (5.00.06) g (5.3) (1 0001

12、2.5) mL (1.00.012 5) mL( .) 1 mol/L . 2.5 mol/L (7.31) pH . . 8.1.3 (Phi-X) . - (7.00.09) g (8.00.1) g (5.00.06) g (5.3) (1 00012.5) mL (1.00.012 5) mL( .) 1 mol/L . 2.5 mol/L (7.31) pH . . 8.2 . a) ： Phi-X174 . KS K ISO 16604:2012 10 b) ： c) ： Phi-X174 0.027 m (0.0500.005) m 8.3 . a) 3 . b) , . c)

13、1 . d) 13.6 N m . e) , Phi-X174 2.0 L 900 PFU 1 200 PFU . f) 2.0 L Phi-X174 5.0 mL . g) 10 min , 8.9 . h) . i) (8.8 ) , Phi-X174 (8.4 ) h) 2108PFU/mL 3108PFU/mL . 5.0 1109PFU/mL . 8.4 . a) E. coli C 250 mL 10 mL 25 mL . (22525) r/min (361) C . b) 100 mL 1 L 1： 100 . (22525) r/min (361) C . 3 h (31)1

14、08CFU/mL . 640 nm 0.3 0.5 . c) 1.0109PFU/mL 1.01010PFU/mL Phi-X174 5 mL 10 mL . 0.1 2.0 . d) , (361) C 1 h 5 h . 640 nm . e) 20 min 10 000 g . . f) 0.22 m , . g) (53) C . (5.02)1010PFU/mL . h) 8.3 . 8.9 . KS K ISO 16604:2012 11 8.5 (settle plate) , , , , Phi-X174 . . a) 2.5 mL (452) C . . b) E. coli

15、 C 100 L . c) , . d) , . e) , . 8.6 , KS K ISO 5084 0.02 mm . , KS K 0541 10 g/m2 . . 8.3 . 8.7 (1221) C, (2147) kPa 15 min . , Phi-X174 . . a) . 1 . b) ( ). , PTFE . 13.6 N m . 2 , . . 8.8 KS K ISO 16604:2012 12 . a) 1 . b) , 60 mL Phi-X174 ( ). , i) . c) . d) . e) , . f) , (3.50.5) kPa/s . g) . h) , . i) . j) , Phi-X174 . k) , . l) , 0.01 % 5.0 mL . 1 min . . , .