KS P ISO 15674-2009 Cardiovascular implants and artificial organs-Hard-shell cardiotomy venous reservoir systems(with without filter) and soft venous reservoir bags 《心脏脉管植入物和人工.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 15674 / KS P ISO 15674:2009 2009 12 21 http:/www.kats.go.krKS P ISO 15674:2009 : ( ) ( ) () () ( ) : (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 15674:2009 i .1 1 1 2 1

2、3 .2 4 (requirements).3 4.1 (biological characteristics).3 4.2 (physical characteristics) 3 4.3 (performance characteristics).3 5 (tests and measurements to determine compliance with this standard) .4 5.1 (general).4 5.2 (biological characteristics).5 5.3 (physical characteristics) 5 6 (information

3、supplied by the manufacturer)6 6.1 ( ) Information to be given on the reservoir(labelling) .6 6.2 (information to be given on the packaging) .6 6.3 (information to be given in the accompanying documents) .6 6.4 (information to be given in the accompanying documents in a prominent form) 7 7 (packagin

4、g).7 9 KS P ISO 15674:2009 / Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems(with/without filter) and soft venous reservoir bags 2001 1 ISO 15674, Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems(with/without fi

5、lter) and soft venous reservoir bags , . 1 (CPB) , 1 , . - , , , . 2 . . ( ) . KS P ISO 10993 1, 1： KS P ISO 10993 11, 11： KS P ISO 11135, KS P ISO 11607 1, 1： , KS P ISO 11607 2, 2： , KS P ISO 13485, KS P ISO 17665 1, , 1： , ISO 10993 7, Biological evaluation of medical devices Part 7： Ethylene oxi

6、de sterilization residuals ISO 14937, Sterilization of health care products General requirements for characterization of a KS P ISO 15674:2009 2 sterilizing agent and the development, validation and routine control of a sterilization process for medical devices 3 . 3.1 (hard-shell cardiotomy reservo

7、ir) , , 3.2 (hard-shell venous reservoir) 3.3 (soft-bag venous reservoir) 3.4 (hard-shell cardiotomy/venous reservoir system) 3.5 (blood-gas exchanger, oxygenator) 3.6 (blood) ( ) , . 3.7 (integral part) 3.8 (operating variable) 3.9 (hold-up volume) . 3.10 (break-through volume) ( ) , KS P ISO 15674

8、:2009 3 3.11 (sealed hard-shell reservoir) 3.12 (priming volume) 4 (requirements) 4.1 (biological characteristics) 4.1.1 (sterility and non-pyrogenicity) . 5.2.1 . 4.1.2 (biocompatibility) . 5.2.2 . 4.2 (physical characteristics) 4.2.1 (general) 5.3.1 5.3.2 , . 4.2.2 (blood volumes) 6.3 k) . 4.2.3 (

9、connectors) 5.3.4 , . 1 4.8 mm, 6.3 mm, 9.5 mm 12.7 mm , KS P ISO 8637 1 ISO 594 2 . 2 KS P ISO 8637 3 . 4.3 (performance characteristics) 1 A . 2 . KS P ISO 15674:2009 4 4.3.1 (cell damage) 6.3 p) . 6 . . 4.3.2 (air-handling capacity) . 6.3 p) . . 4.3.3 priming volume of the filters(where applicabl

10、e) 6.3 o) . . 4.3.4 (defoaming characteristics) 6.3 p) . . 4.3.5 (volume calibration) . 6.3 n) . 4.3.6 (filtration efficiency) . 6.3 p) . . 4.3.7 (break-through volume) 6.3 p) . . 4.3.8 (dynamic priming volume) 6.3 k) . . . 5 (tests and measurements to determine compliance with this standard) 5.1 (g

11、eneral) 5.1.1 . 5.1.2 . KS P ISO 15674:2009 5 5.1.3 (371) . 5.1.4 , (interpolation) . 5.1.5 . . 5.2 (biological characteristics) 5.2.1 (sterility and non-pyrogenicity) KS P ISO 17665 1, KS P ISO 11135, ISO 11137, ISO 14937 KS P ISO 10993 11 . 5.2.2 (biocompatibility) KS P ISO 10993 1 ISO 10993 7 . 5

12、.3 (physical characteristics) 5.3.1 (determination of blood pathway integrity for soft venous reservoir bags) 1.5 , 152 kPa(22 psi) 6 . . 5.3.2 (determination of blood pathway integrity for sealed hard-shell reservoirs) 5.3.2.1 5.3.2.2 1.5 , 152 kPa (22 psi) 6 . . . . 5.3.3 (test liquid) . 5.3.4 (co

13、nnectors) . 15 15 N . KS P ISO 15674:2009 6 6 (information supplied by the manufacturer) 6.1 ( ) Information to be given on the reservoir(labelling) . a) b) , c) d) , e) 6.2 (information 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)

14、 i) 6.2.2 (information to be given on the shipping container) . a) , b) c) d) e) , f) 6.3 (information to be given in the accompanying documents) . a) , , b) c) d) , e) , KS P ISO 15674:2009 7 f) g) h) i) j) k) l) m) n) o) ( , ) p) 1) 2) 3) 4) 5) 6) 7) 8) 6.4 (information to be given in the accompan

15、ying documents in a prominent form) . a) b) c) d) . ： , 7 (packaging) KS P ISO 11607 1 KS P ISO 11607 2 KS P ISO 15674:2009 8 A ( ) 4.3.1 4.3.8 a) 4.3.1 , b) 4.3.2 . a) 6.3 p) . , , , , b) . 6 . . c) . d) . . e) . . f) (： 40 m 78 %) . g) 3.10 . h) . KS P ISO 15674:2009 9 1 ISO 594 2, Conical fitting

16、s with 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 2： Lock fittings 2 KS P ISO 7199, ( ) 3 KS P ISO 8637, , 4 KS P ISO 13485, 5 ISO 14971, Medical devices Application of risk management to medical devices 6 ISO/TS 23810, Cardiovascular implants and artificial organ

17、s Checklist for preoperative extracorporeal circulation equipment setup / 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 15674:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Cardiovascular implants and artificial organsHard-shell cardiotomy/venous reservoir systems(with/without filter) and soft venous reservoir bags ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr