KS K ISO 22610-2010 Surgical drapes gowns and clean air suits used as medical devices for patients clinic staff and equipment-Test method to determine the resistance to wet bacteri.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS K ISO 22610 , KS K ISO 22610 :2010 2010 12 2 http:/www.kats.go.krKS K ISO 22610:2010 : ( ) ( ) Pio FITI ( ) : (http:/www.standard.go.kr) ： ：2010 12 2 2010-0539 ： ： ( 02-509-7278) (http:/www.kats.go.kr). 10 5 , . KS K ISO 22610:2010 i . . , , . , , . KS K

2、 ISO 22610:2010 , Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinic staff and equipmentTest method to determine the resistance to wet bacterial penetration 2006 1 ISO 22610, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, cli

3、nic staff and equipmentTest method to determine the resistance to wet bacterial penetration , . 1 ( A ) . 2 . . ( ) . KS K ISO 139, KS K ISO 6330, KS K ISO 139372, 2： ( ) KS K ISO 15797, KS P ISO 116071, 1：, KS P ISO 116072, 2：, KS P ISO 13485, ISO 13683, Sterilization of health care productsRequire

4、ments for validation and routine control of moist heat sterilization in health care facilities KS K ISO 22610:2010 2 ISO 139341, TextilesTensile properties of fabricsPart 1：Determination of maximum force and elongation at maximum force using the strip method BS EN ISO 176651, Sterilization of health

5、 care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices 3 . 3.1 (agar plate) (nutrient) B 3.2 (carrier material) (donor) 3.3 (covering material) , , 3.4 (donor) 3.5 (finger) 3.6 (replicate test) , . 3.7 (test materia

6、l) 25 cm25 cm , 3.8 (reference material) 3.9 (resistance to wet bacterial penetration) , KS K ISO 22610:2010 3 4 . 10 m (HDPE) . (steel rings) . . (exocentric cam) 15 . , . . 15 , , . 15 5 . . . . ( C ). 5 1)5.1 6 5 14 cm (B.4 7.1 ) 5.2 5 25 cm25 cm, (7.2 ) 5.3 HDPE 5 10 m, 25 cm25 cm 25 cm, HDPE (9

7、502) kg/m 3 , (190 , 5 kg) 0.027 g/min 5.4 (Staphylococcus aureus) ATCC 29213 5.5 5 25 cm25 cm(7.3 ) 5.6 (10.3 ) KS K ISO 6330 KS K ISO 15797 3 135 g/m 2 1) sch tt Labortechnik, RudolfWisselStra e 11, D37079 G ttingen, Germany . , ISO .KS K ISO 22610:2010 4 6 6.1 (cylindrical body) 9 cm, 4 cm 6.2 A

8、, . 14 cm . (lever) , (60 r/min) , . . (5060) r/min . 11 mm , . (3 0.02) N , . . 10. . . 7 7.1 14 cm 6 (B.4 ) (30.2) mm . (5.1 ) (244) h . 20 . . , . . . , . (wire gauges) (dial indicator) . . 7.2 (5.2 ) 30 m (solvent-cast polyurethane) (PU) , MD (35050) %, CD (40075) %, . KS K ISO 22610:2010 5 25 c

9、m25 cm . ISO 13683 121 . 7.3 KS K ISO 139372 ISO 139341 5 . 8 8.1 (Staphylococcus aureus) ATCC 29213 (361) 1824 (Tryptic Soy) . (B.2 ) 3 mL 2 3 (361) 18 24 . 110 4 4 10 4CFU/mL (peptone water)(B.3 ) 1 ：10 . PU . PU . . . (Staphylococcus aureus) 1.0 mL . 56 30 . (spreader) (polymer) . . 8.2 (conditio

10、ning) KS K ISO 139 . . . 8.3 (30.02) N . . 8.4 (8001) g ( A.2, A.3 ) . , PU () . HDPE (5.3 ) PU , 3 2 . 8.5 , . . HDPE . 3 N 15 . KS K ISO 22610:2010 6 15 , . . . 4 . 5 , HDPE . 6 15 . 4 15 6 , . , (361) 48 . (Staphylococcus aureus) . 15 mm . 750 CFU ( ) . 750 CFU , . 9 . a) b) 10.2 10.3 c) ( , ) d)

11、 (brim) e) f) 7.3 g) 7.2 h) i) C . 10 (performance monitoring) 10.1 . . 10.2 (carbon paper) KS K ISO 22610:2010 7 8.4 , , HDPE . 14 cm 8.4 . HDPE 15 . . 10.3 5.6 . KS P ISO 13485 . . . KS P ISO 116071 KS P ISO 116072 BS EN ISO 17665 1 121 . CUM5 0.700.96 ( C ). KS K ISO 22610:2010 8 A () 1 2 3 4 5 6

12、 7 8 (ball bearing) A.1 KS K ISO 22610:2010 9 ：mm A.2 KS K ISO 22610:2010 10 ： mm A.3 KS K ISO 22610:2010 11 B () (nutrient) B.1 (tryptic soy) (tryptone) 15 g papaic digest of soybean meal 5 g (sodium chloride) 5 g (agar) 17 g 1 000 mL . 121 15 . B.2 (tryptone) 17 g papaic digest of soybean meal 3 g

13、 (dextrose) 2.5 g (sodium chloride) 5 g (dipotassium phosphate) 2.5 g 1 000 mL B.3 (Peptone water) (peptone) 10 g (sodium chloride) 5 g 80(polysorbate 80) 1 g 1 000 mL KS K ISO 22610:2010 12 B.4 (beef extract) 3 g (peptone) 5 g (sodium chloride) 8 g (agar) 17 g 1 000 mL B.1 . . KS K ISO 22610:2010 1

14、3 C () C.1 T . TZX 1 X 2 X 3 X 4 X 5 (C.1) Z ：5 6 ( 6) X 1 , ,X 5 ： 5 C.2 1 5 R CUM1 , ., R CUM5 . T x R 1 CUM1 (C.2) T x x R 2 1 CUM2 (C.3) T x x x R 3 2 1 CUM3 (C.4) T x x x x R 4 3 2 1 CUM4 (C.5) T x x x x x R 5 4 3 2 1 CUM5 (C.6) R CUM5 . C.3 C BP , . C BP (C.7) (C.8) . 2 1 CUM5 CUM4 CUM3 CUM2 C

15、UM1 BP R R R R R C (C.7) 2 1 2 3 4 5 4 3 2 1 4 3 2 1 BP x x x x x x x x x C (C.8) KS K ISO 22610:2010 14 (C.8) C BP , . 1 4 C BP 1/2, 5 . C.4 I B , . I B . C BP R CUM5 . I B . I B (C.9) (C.10) . I B (C.9) C BP R CUM5 , I B . 2 6 CUM5 CUM5 BP B R R C I (C.9) CUM5 CUM4 CUM3 CUM2 CUM1 B 6 R R R R R I (

16、C.10) KS K ISO 22610:2010 15 D () D.1 . D.1 () 2010.12.2. 20100539 2009 “ISO TC38/TC94 ” ： , ：ISO 22610 KS K ISO 22610:2010 16 1 EN 137951, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipmentPart 1：General requirements for manufacturers, pr

17、ocessors and products 2 EN 137952, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipmentPart 2：Test methods 3 EN 137953, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipmentPart 3：Per

18、formance requirements and performance levels 4 RANSJ, U., AND HAMBRAEUS, A., AN instrument for measuring the bacterial penetration through fabrics used for barrier clothing. Journal of Hygiene (1979) 82, pp. 361368 5 WHYTE, W., HAMBRAEUS, A., LAURELL, G., and HOBORN, J., The relative importance of r

19、outes and sources of wound contamination during general surgery. I. Nonairborne. Journal of Hospital Infection (1991) 18, pp. 93107 6 WERNER, H.P., HOBORN, J., SCHN, K., and PETRI, B., Influence of drape permeability on wound contamination during mastectomy. European Journal of Surgery (1991) 157, p

20、p. 379383 7 HOBORN, J., Theatre Drapes and GownsHow to Determine Wet Bacterial Barrier Properties. HygMed (2000) 25, pp. 7983 8 HOBORN, J., How to Determine Bacterial Barrier PropertiesPart II：Further improvements. HygMed (2000) 25, pp. 309313 9 HOBORN, J., How to Determine Bacterial Barrier PropertiesPart III：Validation of a test method. HygMed (2002) 27, pp. 7478 , 153787 1 92 3(13) (02)26240114 (02)262401489 http：/ KS K ISO 22610 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Surgical drapes, gowns and clean air suits, used as medical devices, f