KS P ISO TS 23810-2009 Cardiovascular implants and artificial organs－Checklist for preoperative extracorporeal circulation equipment setup《心血管植入物和人造器官 手术前体外循环设备的调试检查清》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO TS 23810 KS P ISO TS 23810:2009 2009 12 29 http:/www.kats.go.krKS P ISO TS 23810:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： (ISO/TC 194) ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO TS 23810:2009 .

2、 . ii 1 1 2 1 3 1 3.1 1 3.2 / .2 3.3 , .3 3.4 4 3.5 5 3.6 5 3.7 6 3.8 6 3.9 7 3.10 .7 3.11 8 3.12 .8 3.13 9 3.14 .9 4 10 4.1 10 4.2 10 4.3 .10 4.4 10 5 10 i KS P ISO TS 23810:2009 2006 1 ISO/TS 23810, Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation

3、 equipment setup . . . , , . , , . ii KS P ISO TS 23810:2009 Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment setup 1 (CPB), (ECMO), (CPS), (LHB, RHB) (VV) . , . . 2 . . ( ) . American Academy of Cardiovascular Perfusion(Allentown, PA) : S

4、tandards of practice. Proc. Am. Acad. Cardiovasc. Perfusion 1987, 8, 272-274 American Society of Extra-Corporeal Technology(Reston, VA) : Pre-bypass perfusion safety checklist. Perfusion Life 1990, 7, 76-77 American Society of Extra-Corporeal Technology(Reston, VA) : AmSECT Perfusion Checklist, AmSE

5、CT Quality Committee , 2004 : Anesthesia apparatus checkout recommendations, 1993, American Society of Anesthesiology (FDA) 3 3.1 3.1.1 . 3.1.2 3.1.2.1 . 3.1.2.2 . KS P ISO TS 23810:2009 3.1.3 ID . 3.1.4 . 3.1.5 3.1.5.1 ID . 3.1.5.2 . 3.1.6 , . 3.1.7 ( : , ) . 3.1.8 3.1.8.1 . 3.1.8.2 . 3.1.9 3.1.9.1

6、 / . 3.1.9.2 . 3.2 / 3.2.1 / . 3.2.2 (, , ) ID . 2 KS P ISO TS 23810:2009 3.2.3 . 3.2.4 ( 水相) . . 3.2.5 . 3.3 , 3.3.1 3.3.1.1 3.3.1.1.1 . 3.3.1.1.2 . 3.3.1.1.3 . 3.3.2 3.3.2.1 . 3.3.2.2 AC , . 3.3.3 3.3.3.1 . 3.3.3.2 . , . 3.3.4 , , , . 3.3.5 3.3.5.1 . 3 KS P ISO TS 23810:2009 3.3.5.2 . 3.3.6 . 3.3.

7、7 . 3.3.8 / . . 3.3.9 . 3.3.10 . 3.3.11 . 3.3.12 . 3.4 3.4.1 , . 3.4.2 - . 3.4.3 . 3.4.4 . 4 KS P ISO TS 23810:2009 3.5 3.5.1 . 3.5.2 . 3.5.3 / . 3.5.4 . 3.5.5 . 3.5.6 . 3.5.7 . 3.5.8 . 3.6 3.6.1 / / , , . 3.6.2 . 3.6.3 / / . 5 KS P ISO TS 23810:2009 3.6.4 . 3.6.5 . 3.6.6 . . . 3.6.7 . 3.6.8 / . 3.7

8、 3.7.1 , 3.7.1.1 . 3.7.1.2 . 3.7.2 / . 3.7.3 / (hard-shell) . 3.7.4 . 3.7.5 . 3.8 3.8.1 6 KS P ISO TS 23810:2009 / . 3.8.2 / . 3.8.3 / . 3.8.4 3.8.4.1 . 3.8.4.2 . 3.8.4.3 . 3.9 3.9.1 ( ) . 3.9.2 / ( ) , . 3.9.3 : / , , , (haemoglobin)/ (haematocrit) . 3.9.4 (sweep gas) / ( : 21 % 100 %) . 3.10 3.10.

9、1 . 3.10.2 . 7 KS P ISO TS 23810:2009 3.11 3.11.1 ( : , ) . 3.11.2 (: , ) . 3.11.3 ( ) . 3.12 3.12.1 . 3.12.2 3.12.2.1 . 3.12.2.2 , . 3.12.3 ( : , ) . 3.12.4 . 3.12.5 / / . 3.12.6 . 3.12.7 . 8 KS P ISO TS 23810:2009 3.13 3.13.1 (hand crank) . 3.13.2 ( : ) . 3.13.3 . 3.13.4 ( : , , , , , ) . 3.13.5 .

10、 3.14 3.14.1 . 3.14.2 . 3.14.3 . 3.14.4 . 3.14.5 / . 9 KS P ISO TS 23810:2009 4 4.1 4.1.1 , . 4.1.2 . 4.2 , . 4.3 . 4.4 . 5 (point-of-care) / . 10 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO TS 23810:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Cardiovascular implants and artificial organsChecklist for preoperative extracorporeal circulation equipment setup ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr