KS P ISO 15675-2009 Cardiovascular implants and artificial organs－Cardiopulmonary bypass systems－Arterial blood line filters《心脏脉管和人工器官 心脉旁通系统 动脉血过滤器》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 15675 KS P ISO 15675:2009 2009 12 21 http:/www.kats.go.krKS P ISO 15675:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 15675:2009 i .1 1 1 2 1 3

2、.2 4 (requirements).2 4.1 (biological characteristics).2 4.2 (biocompatibility).3 4.3 (physical characteristics) 3 4.4 (performance characteristics).3 5 (tests and measurements to determine compliance with this international standard)4 5.1 (general).4 5.2 (biological characteristics).4 5.3 (physical

3、 characteristics) 4 5.4 (performance characteristics).5 6 (information supplied by the manufacturer)7 6.1 (information to be given on the arterial filter).7 6.2 (information to be given on the packaging)7 6.3 (information to be given in the accompanying documents).7 6.4 (information to be given in t

4、he accompanying documents in a prominent form) 8 7 (packaging).8 9 KS P ISO 15675:2009 Cardiovascular implants and artificial organs Cardiopulmonary bypass systems Arterial blood line filters 2009 2 ISO 15675, Cardiovascular implants and artificial organsCardiopulmonary bypass systems Arterial blood

5、 line filters , 1 , , . 2 . . ( ) . KS P ISO 10993 1, 1： KS P ISO 10993 11, 11： KS P ISO 11135, KS P ISO 11137 1, 1： , KS P ISO 11607 1, 1： , KS P ISO 13485, KS P ISO 17665 1, , 1： , ISO 594 2, Conical fittings with 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 2： Lo

6、ck fittings ISO 10993 7, Biological evaluation of medical devices Part 7： Ethylene oxide sterilization residuals 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 pr

7、ocess for medical devices KS P ISO 15675:2009 2 3 . 3.1 (arterial blood line filter) , 3.2 (blood pathway) 3.3 (blood) 3.4 (blood cell damage) 3.5 (platelet percentage reduction) , ( ), 3.6 (plasma-free heamoglobin generation) , 3.7 (white blood cell percentage reduction) , ( ), 3.8 (filtration effi

8、ciency) , . 3.9 (blood analogue) 4 (requirements) 4.1 (biological characteristics) 4.1.1 (sterility and nonpyrogenicity) KS P ISO 15675:2009 3 . 5.2.1 . 4.1.2 (biocompatibility) . 5.2.2 . 4.2 (physical characteristics) 4.2.1 (blood pathway integrity) 5.3.1 , . 4.2.2 (blood volume) (6.3 ). 4.2.3 (con

9、nectors) 5.3.3 , . ISO 594 2 . 4.8 mm, 6.3 mm, 9.5 mm, 12.7 mm KS P ISO 7199 . 4.3 (performance characteristics) 4.3.1 (blood cell damage) 5.4.1 , , (6.3 ). 4.3.2 (filtration efficiency) 5.4.2 , 40 m 100 m 50 % 80 % . 4.3.3 (flowrate capacity) 5.4.3 , . 4.3.4 (shelf life) 5.4.4 , . 4.3.5 (air-handli

10、ng capacity) 5.4.5 , . KS P ISO 15675:2009 4 5 (tests and measurements to determine compliance with this international standard) 5.1 (general) 5.1.1 . 5.1.2 . 5.1.3 , (371) . 5.1.4 , . 5.1.5 . . 5.2 (biological characteristics) 5.2.1 (sterility and nonpyrogenicity) KS P ISO 17665 1, KS P ISO 11135,

11、KS P ISO 11137 1, ISO 14937 KS P ISO 10993 11 . 5.2.2 (biocampatibility) KS P ISO 10993 1 ISO 10993 7 . 5.3 (physical characteristics) 5.3.1 ( )determination of blood pathway integrity(sterile final assembly) 1.5 152 kPa(22 psi) 6 . . 5.3.2 (test liquid) . (6.3 ). 5.3.3 (connector) KS P ISO 15675:20

12、09 5 . 15 15 N . 5.4 (performance characteristics) 5.4.1 (blood cell damage) 5.4.1.1 (test media) . 5.4.1.2 (procedure) , , ( , ) . . 1 % . 1 . 1 (6.3 ) 6 L/min 5 % 10 mmol/dL 0.5 mmol/dL 12 g/dL 1 g/dL 2 . 2 () Prior to test 30 180 360 5.4.2 (filtration efficiency) 5.4.2.1 (test liquid) 40 m 100 m

13、350 5 000 KS P ISO 15675:2009 6 33 % . 5.4.2.2 (procedure) 152 kPa(22 psi) , 100 mL/ 500 mL . . ANSI/AAMI AT6 1991 4.2.4 . 40 m 100 m 100 . 10 . 5.4.3 (filter flow rate) 5.4.3.1 (test liquid) ( ). 5.4.3.2 (procedure) . 6 . . . . 5.4.4 (shelf life or expiry date) , . 5 . 5.4.5 (air-handling capacity)

14、 5.4.5.1 (test liquid) (121) g/dL . 5.4.5.2 (procedure) 1 (3.2 mm I.D.) . 26.6 kPa(3.9psi)5 % . 5 . 33 %, 67 % 100 % 30 mL( 10 mL) . 5.4.5.3 (results) . KS P ISO 15675:2009 7 6 (information supplied by the manufacturer) 6.1 (information to be given on the arterial filter) . a) b) c) 6.2 (information

15、 to be given on the packaging) 6.2.1 (information to be given on the unit container) . a) b) c) d) , e) f) , g) “ ” h) i) 6.2.2 (information to be given on the shipping container) . a) b) c) d) e) 6.3 (information to be given in the accompanying documents) “ ” . a) b) c) d) , e) f) , g) h) KS P ISO

16、15675:2009 8 i) j) k) l) m) n) 1) 2) 3) 4) o) , 6.4 (information to be given in the accompanying documents in a prominent form) . a) b) , , 7 (packaging) KS P ISO 13485 KS P ISO 11607 1 . KS P ISO 15675:2009 9 1 KS P ISO 7199, ( ) 2 KS P ISO 10993 10, 10： 3 KS P ISO 13485, 4 ISO 14971, Medical devic

17、es Application of risk management to medical devices 5 KS P ISO 15223, , 6 ISO/TS 23810, Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment setup 7 ANSI/AAMI AT6 2005, Autologous transfusion devices 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 15675:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Cardiovascular implants and artificial organsCardiopulmonary bypass systemsArterial blood line filters ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr