KS P ISO 16391-2011 Aids for ostomy and incontinence－Irrigation sets－Requirements and test methods《造口术和失禁辅助器具 冲洗设备 要求和试验方法》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 16391 KS P ISO 16391:2011 2011 12 13 http:/www.kats.go.krKS P ISO 16391:2011 : ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2011 12 13 2011-0564 ： ： ( 02-509-7278) (http:/www.kats.go.kr). 10 5 , . KS P ISO 16391:2011 i . ii 1 1 2 1 3 .1 4 .3 4.1 3 4.

2、2 3 4.3 4 4.4 4 4.5 4 4.6 4 5 4 5.1 .4 5.2 .4 5.3 4 6 4 6.1 4 6.2 5 6.3 5 6.4 6 6.5 6 6.6 7 7 .7 KS P ISO 16391:2011 ii 2002 1 ISO 16391, Aids for ostomy and incontinenceIrrigation setsRequirements and test methods . KS P ISO 16391:2011 Aids for ostomy and incontinence Irrigation sets Requirements a

3、nd test methods 1 . 2 . . ( ) . KS P ISO 8670 2, 2： KS P ISO 10993 1, 1： 3 . 1 . 3.1 (belt) 3.2 (colostomy) 3.3 (connector) 3.4 (drainage system) , , , (hook) KS P ISO 16391:2011 2 3.5 (drainage sleeve) 3.6 (flow controller) . 3.7 (flow indicator) 3.8 (inflow system) , , , , , , , . 3.9 (irrigation)

4、 . 3.10 (irrigation set) . 3.11 (irrigation water bag) 3.12 (pressure plate) 3.13 (stoma) KS P ISO 8670 2 3.14 (stoma adaptor) 3.15 (test volume) KS P ISO 16391:2011 3 3.16 (tube) 3.17 (volume indicator) ： mm 1 6 11 2 7 12 3 8 13 4 9 14 5 10 1 ( ) ( ) 4 4.1 6.1 , (3.17) 15 % . (3.15) 15 % . 4.2 KS P

5、 ISO 16391:2011 4 6.2 , (3.10) (3.8) . 4.3 6.3 , 200 mL/min . 4.4 6.4 , (3.11) / . 4.5 6.5 , (3.1) / (3.12) . 4.6 KS P ISO 10993 1 , (3.10) . 5 5.1 (232) . 1 . (372) , 32 . 5.2 5.2.1 , 0.3 g/L (E127) . 5.3 . 6 6.1 6.1.1 (3.11) . . 6.1.2 6.1.2.1 , 500 mL, 2 000 mL . 6.1.3 (3.6) , (3.11) , KS P ISO 16

6、391:2011 5 (3.10) (3.8) . 500 mL (6.1.2.1) (3.17) , 2 000 mL . , 2 000 mL . 6.1.4 7. . 6.2 6.2.1 (3.10) (3.8) . . 6.2.2 (3.14) (3.6) (3.8) . 6.1 (5.2.1) , . 30 . . . . 30 . . 6.2.3 , 7. . 6.3 6.3.1 . 6.3.2 6.3.2.1 , 500 mL . 6.3.2.2 , 6.3.3 (3.10) (3.6) . KS P ISO 16391:2011 6 6.1 (5.2.1) . (3.14) (

7、3.11) (60050) mm . . (6.3.2.1) 1 . 6.3.4 (6.3.3 ) 7. . 6.4 6.4.1 , . 6.4.2 . 49 N 30 . , . . 8 mm . 5 kg . 6.4.3 7. . 6.5 6.5.1 30 , (3.12) . 6.5.2 (3.1) (3.12) . 30 49 N . 5 kg . KS P ISO 16391:2011 7 . 6.5.3 7. . 6.6 6.6.1 (3.8) KS P ISO 10993 . 6.6.2 KS P ISO 10993 1 KS P ISO 10993 1 . KS P ISO 1

8、0993 1 / . 6.6.3 (3.10) (3.8) 7. . 7 . a) (KS P ISO 16391) b) c) d) e) 6.1.4, 6.2.3, 6.3.4, 6.4.3, 6.5.3 6.6.3 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 16391:2011 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Aids for ostomy and incontinence Irrigation setsRequirements and test methods ICS 11.180 Korean Agency for Technology and Standards http:/www.kats.go.kr