KS P ISO 15676-2007 Cardiovascular implants and artificial organs-Requirements for single-use tubing packs for cardiopulmonary bypass(CBP) and extracorporeal membrane oxygenation(E.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 15676 (CBP) (ECMO) KS P ISO 15676： 2007 (2012 ) 2007 12 18 http:/www.kats.go.krKS P ISO 15676： 2007 : ( ) ( ) () ( ) () ( ) () ( ) : (http:/www.standard.go.kr) ： ：2007 12 18 ：2012 12 6 20120679 ： ： (TC150) ( 02-509-7294) (http:/www.kats.go.kr). 10 5

2、 , . KS P ISO 15676： 2007 i .1 1 1 2 1 3 .2 4 3 4.1 3 4.2 3 4.3 3 5 .4 5.1 .4 5.2 4 5.3 5 5.4 5 6 .6 6.1 6 6.2 6 6.3 .7 6.4 .7 7 7 8 KS P ISO 15676： 2007 (2012 ) (CBP) (ECMO) Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass(CBP) and ex

3、tracorporeal membrane oxygenation(ECMO) 2005 1 ISO 15676, Cardiovascular implants and artificial organsRequirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation(ECMO) , . 1 (ECMO) . (CPB) / (ECMO) , CPB ( , 6 ) ECMO ( , 24 ) . EO (EO) (ECH) EO ECO .

4、EO . “sterile( )” . ( ), , , , . 2 . . ( ) . KS M ISO 34 1： 2004, 1： , KS M ISO 527 1： 2007, 1： KS M ISO 9352： 2007, KS P ISO 15676： 2007 2 KS P ISO 10993 1： 2007, 1： KS P ISO 10993 11： 2007, 11： KS P ISO 11134： 2003, KS P ISO 11135： 2003, KS P ISO 11607 1： 2007, 1： , KS P ISO 11607 2： 2007, 2： , IS

5、O 10993 7, Biological evaluation of medical devices Part 7： Ethylene oxide sterilization residuals ISO 11137 1, Sterilization of health care products Radiation Part 1： Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137 2, Sterilizati

6、on of health care products Radiation Part 2： Establishing the sterilization dose ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ASTM D

7、 792 00, Standard test methods for density and specific gravity (relatively density) of plastics by displacement ASTM D 1044 99, Standard test method for resistance of transparent plastics to surface abrasion ASTM D 2240 04, Standard test method for rubber property Durometer hardness 3 . 3.1 (durome

8、ter harness) A 3.2 (elongation) 3.3 (tensile strength) 3.4 (tear strength) (stress) 3.5 (tubing) CPB ECMO . 3.6 (specific gravity) 4 KS P ISO 15676： 2007 3 3.7 (spallation) 3.8 (brittle point) 1 50 % 4 4.1 4.1.1 . 5.2.1 . 4.1.2 . 5.2.2 . 4.2 4.2.1 5.3.1 . 4.2.2 , , . 4.2.3 6.4 b) , . 5.3.3 . . . a)

9、b) c) d) e) f) 4.3 KS P ISO 15676： 2007 4 4.3.1 (priming volume) , 6.2 e) . . . . 4.3.2 5.4.1 . 6.2 c) . 6.3 d) . 4.3.3 (spallation) 5.4.2 , 8 6.4 c) . 1 6 . 5 5.1 5.1.1 . 5.1.2 . 5.1.3 4 , 30 39 . 5.1.4 , . 5.1.5 . . 5.2 5.2.1 KS P ISO 11134, KS P ISO 11135, ISO 11137 1, ISO 11137 2 ISO 14937 . 5.2

10、.2 KS P ISO 10993 1 KS P ISO 10993 11 . ISO 10993 7 . KS P ISO 15676： 2007 5 5.3 5.3.1 5.3.1.1 . . 5.3.1.2 1.5 (positive pressure) . 60 kPa . 6 . (decay) . 5.3.2 15 N 15 . . 5.3.3 KS M ISO 34 1, KS M ISO 527 1, KS M ISO 9352, ASTM D 792 00, ASTM D 1044 99 ASTM D 2240 04 . 5.4 5.4.1 5.4.1.1 (glycerin

11、e-isotonic salt) . 1.010 3Pa s(1.0 cP), 2.010 3Pa s(2.0 cP), 3.0103Pa s(3.0 cP) . 5.4.1.2 , , , . . , , , . 5.4.1.3 1 mL/min . 5.4.2 5.4.2.1 , . (volume/hour) . 5.4.2.2 . 5 m CPB 20 , 5 m ECMO 39 . 5.4.2.3 5.4.1.2 KS P ISO 15676： 2007 6 . 5.4.2.4 . 8 . 5.4.2.4.1 CPB 6 . 1 , 2 , 4 6 . 5.4.2.4.2 ECMO

12、24 . 5.4.2.5 1 10 m . . 5.4.2.6 1 . 6 6.1 6.1.1 . a) b) c) d) e) , f) “ ” g) h) i) 6.1.2 . a) b) c) d) e) f) , 6.2 . a) ( ) KS P ISO 15676： 2007 7 b) c) d) , e) f) g) 1) 2) 6.3 . a) b) c) d) e) , 6.4 . a) 5.3.3 b) (4.2.3 ) c) 7 KS P ISO 11607 1 KS P ISO 11607 2 . KS P ISO 15676： 2007 8 1 ASTM D 624

13、00e1, Standard test method for tear strength of conventional vulcanized rubber and thermoplastic elastomers 2 ASTM D 638 03, Standard test method for tensile properties of plastics 3 BARRON, D., HARBOTTLE, S., HOENICH, N.A., MORLEY, A.R., APPLETON, D. and MCCABE, J.F. Particle spallation induced by

14、blood pumps in hemodialysis tubing sets. Artif. Organs, 10 (3), 1986 Jun, pp. 226 235 4 BOMMER, J., PERNICKA, E., KESSLER, J. and RITZ, E. Reduction of silicone particle release during haemodialysis. Proc. Eur. Dial Transplant Assoc. Eur. Ren. Assoc., 21, 1985, pp. 287 290 5 BRICENO, J.C. and RUNGE,

15、 T.M. Tubing spallation in extracorporeal circuits. An in vitro study using an electronic particle counter. Int. J. Artif. Organs. 15 (4), 1992 Apr, pp. 222 228 6 CAREY, R.F. and HERMAN, B.A. The effects of a glycerin-based blood analog on the testing of bioprosthetic heart valves. J. Biomech., 22 (

16、11 12), 1989, pp. 1185 1192 7 COISNE, D. et al. Quantitative assessment of reguritant flow with total digital three-dimensional reconstruction of doppler flow in the convergent region ： in vitro validation. J. Am. So. Echocardiogr.,15, 2002, pp. 233 240 8 GORDON, R.J., RAVIN, M.B. and DAICROFF, G.R.

17、 Cardiovascular Physiology For Anesthesiologists, Springfield, Ill, CHARLES, C. Thomas Publisher, 1979, pp. 27 71 9 GORDON, R.J. and RAWITCSCHER, R.E. Changes in arterial pressure, viscosity and resistance during cardioplumonary bypass J. Thoracic Cardiovasc. Surg., 69, 1975, pp. 552 561 10 HOENICH,

18、 N.A., THOMPSON, J., VARINI, E., MCCABE, J. and APPLETON, D. Particle spallation and plasticizer (DEHP) release from extracorporeal circuit tubing materials. Int. J. Artif. Organs. 13 (1), 1990 Jan, pp. 55 62 11 KIM, W.G. and YOON, C.J. Roller pump induced tubing wear of polyvinylchloride and silico

19、ne rubber tubing： phase contrast and scanning electron microscopic studies. Artif Organs, 22 (10), 1998 Oct, pp. 892 897 12 PEEK, G.J., THOMPSON, A., KILLER, H.M. and FIRMIN, R.K. Spallation performance of extracorporeal membrane oxygenation tubing. Perfusion, 15 (5), 2000 Sep, pp. 457 466 13 RAND,

20、P.W., LACOMBE, E. and HUNT, H.E., et al. Viscosities of normal human blood under normal and hypothermic conditions. J. Appl. Physiol., 19, 1963, pp. 117 122 14 ROBICSEK, F., MASTERS, T.N., NIESLUCHOWSKI, W., YEAGER, J.C., DUNCAN, G.D. Vasomotor activity during cardiopulmonary bypass. Ch.1 in Utley J

21、.R. (Ed), Pathophysiology and Techniques of Cardioplumonary Bypass, Vol. 2, Baltimore, Williams and Wilkins, 1983, p. 6 (CBP) (ECMO) 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 15676： 2007KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass(CBP) and extracorporeal membrane oxygenation(ECMO) ICS 11.040.40