KS P ISO 5840-2007 Cardiovascular implants－Cardiac valve prostheses《心血管植入物 心脏瓣膜修复术》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5840 KS P ISO 5840： 2007 (2012 ) 2007 10 31 http： /www.kats.go.krKS P ISO 5840： 2007 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 6 29 ：2007 10 31 ：2012 12 6 ： 20120679 ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5840： 2007

2、i .1 1 1 2 1 3 .2 4 11 5 12 6 .12 6.1 12 6.2 12 6.3 13 6.4 ( )14 6.5 14 7 / .15 7.1 15 7.2 16 7.3 .19 7.4 21 A( ) 26 B( ) .29 C( ) .31 D( ) .38 E( ) .44 F( ) 45 G( ) 47 H( ) .50 I( ) .53 J( ) 54 K( ) .57 L( ) .62 M( ) 68 N( ) .70 O( ) 72 KS P ISO 5840： 2007 ii P( ) .77 Q( ) 78 R( ) .80 S( ) .82 83 K

3、S P ISO 5840： 2007 (2012 ) Cardiovascular implants Cardiac valve prostheses 2005 4 ISO 5840, Cardiovascular implants Cardiac valve prostheses , . 1 1.1 . 1.2 , . 1.3 . . , , . . 1.4 / . 1.5 . A . 2 . . ( ) . KS P ISO 10993 1： 2007, 1： KS P ISO 11134： 2003, KS P ISO 11135： 2003, KS P ISO 11137： 2003,

4、 KS P ISO 11607( )： 2007, KS P ISO 13485： 2007, ISO 9001 KS P ISO 14155 1： 2007, 1： KS P ISO 5840： 2007 2 KS P ISO 14630： 2003, KS X ISO 8601： 2003, ISO 10993 2： 1992, Biological evaluation of medical devices Part 2： Animal walfare requirements ISO 14160： 1998, Sterilization of single-use medical de

5、vices incorporating materials of animal originValidation and routine control of sterilization by liquid chemical sterilants ISO 14937： 2000, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a

6、 sterilization process for medical devices ISO 14971： 2000, Medical devices Application of risk management to medical devices EN 12442 1, Animal tissues and their derivatives utilized in the manufacture of medical devices Part 1： Analysis and management of risk EN 12442 2, Animal tissues and their d

7、erivatives utilized in the manufacture of medical devices Part 2： Controls on sourcing, collection and handling EN 12442 3, Animal tissues and their derivatives utilized in the manufacture of medical devices Part 3： Validation of the elimination and/or inactivation of viruses and transmissible agent

8、s Guidelines for reporting morbidity and mortality after cardiac valvular operations, American Association for Thoracic Surgery, European Association for Cardiothoracic Surgery, Society of Thoracic Surgeons, Annals of Thoracic Surgery, 62, pp. 932 935, 1996 3 . 3.1 (accessories) 3.2 (actuarial) “ (K

9、aplan Meier)” “ (life table)” . 3.3 (anticoagulant-related haemorrhage) , , / . 3.4 (arterial diastolic pressure) 3.5 (arterial peak systolic pressure) 3.6 (back pressure) KS P ISO 5840： 2007 3 3.7 (blood-equivalent fluid) , 3.8 (closing volume) ( 1 ) 3.9 (control valve) , . 3.10 (cumulative inciden

10、ce) “ ” . 3.11 (cycle) 3.12 (cycle rate) . / . 3.13 (design verification) KS P ISO 5840： 2007 4 1 3.14 (design validation) 3.15 (effective orifice area) AEO 3.16 (failure) . / . 3.17 (failure mode) (stent) , . 3.18 (flexible heart valve substitute) (occluder) . , . KS P ISO 5840： 2007 5 3.19 (forwar

11、d-flow phase) 3.20 (hazard) (harm) 3.21 (harm) A ISO/IEC Guide 51： 200314 3.3 . 3.22 (heart valve substitute) (3.18, 3.48 J.1, J.2, J.3, J.4, J.5 ) 3.23 (intended use) , , 3.24 (internal orifice area) IOA ( 2 ) 3.25 (intra-annular sewing ring) ( 2 , 3.24, 3.66 3.70 ) 3.26 (intrasupra-annular sewing

12、ring) ( 2 , 3.24, 3.66 3.70 ) KS P ISO 5840： 2007 6 (Key) 1 IOA 2 TAD 3 ESRD 2 3.27 ( ) isolated (aortic or mitral) heart valve substitute (7.4.4 ). 3.28 (leakage volume) ( 1 ). 3.29 (linearized rate) . , . 3.30 (long term follow-up) ( ) 3.31 (manufacturer) 3 , , , , 3.32 (mean arterial pressure) 1

13、11 2 22 3 3 3 KS P ISO 5840： 2007 7 3.33 (mean pressure difference) “ (mean pressure gradient)” . 3.34 (nonstructural dysfunction) (thrombosis), (embolus), . (pannus) , , , . 3.35 (occluder) “leaflets” “cusps” . 3.36 (operative mortality) 30 3.37 (outflow tract profile height) , ( ) 3.38 (pannus) 3.

14、39 (paravalvular leak) “perivalvular” . 3.40 (probability) 3.41 (process validation) . KS P ISO 5840： 2007 8 3.42 (profile height) 3.43 (prosthetic valve endocarditis) . , ( , , , ) . , . 3.44 (quasi-real time durability testing) (200 cycles/min) 3.45 (reference valve) , . , . . 3.46 (regurgitant fr

15、action) 3.47 (regurgitant volume) . ( 1 ). 3.48 (rigid heart valve substitute) . , . 3.49 (risk) KS A ISO/IEC Guide 51： 200314 3.2 3.50 (risk analysis) KS P ISO 5840： 2007 9 KS A ISO/IEC Guide 51： 200314 3.10 . 3.51 (risk assessment) KS A ISO/IEC Guide 51： 200314 3.12 3.52 (risk control) . 3.53 (ris

16、k estimation) 3.54 (risk evaluation) KS A ISO/IEC Guide 51： 200314 3.7 3.11 . 3.55 (risk management) , , , 3.56 (root mean square forward flow)(RMS forward flow) 1 (1) . 122vv12RMSd)(ttttqqtt= RMSvq ： q(t) ： t t1： t2： 2 RMSvq . 3.57 (safety) KS A ISO/IEC Guide 51： 200314 3.1 KS P ISO 5840： 2007 10 3

17、.58 (severity) 3.59 (simulated cardiac output) 3.60 (special processes) 3.61 (sterile) 3.62 (sterility assurance level)(SAL) 3.63 (sterilization) 3.64 (stroke volume) 3.65 (structural deterioration) , . , , , , , . 3.66 (supra-annular sewing ring) ( 2 ) 3.67 (systemic embolism) , , , ( ) ( ) . . 40

18、. KS P ISO 5840： 2007 11 3.68 (tissue annulus diameter)(TAD) 3.69 (validation) 3.70 (valve size) (TAD, mm) (： TAD ) A.7, Q.2.2 c), Q.2.3 b) Q.2.3 g) . 3.71 (valve thrombosis) , ( , ) . 3.72 (verification) 4 , . ABS (Body Surface Area) AEO (Effective Orifice Area) AF (Atrial Fibrilation) ALARP (As Lo

19、w As Reasonably Practicable) AWT (Accelerated Wear Testing) BSE (Bovine Spongiform Encephalopathy) CFD (Computational Fluid Dynamics) ECG (Electrocardiogram) ESRD (External Sewing Ring Diameter) FEA (Finite Element Analysis) FMEA (Failure Mode and Effect Analysis) FTA (Fault Tree Analysis) IFU (Inst

20、ructions For Use) INR (International Normalized Ratio) IOA (Internal Orifice Area) OPC (Objective Performance Criteria) PROB (Probability Rating) KS P ISO 5840： 2007 12 RIND (Reversible Ischemic Neurological Deficits) RPN (Risk Priority Number SEVPROB) SEV (Hazard Severity Rank) SEM (Scanning Electr

21、on Microscopy) TAD (Tissue Annulus Diameter) 5 , . ISO 14971 KS P ISO 13485 . 6 6.1 , , . 6.2 6.2.1 , , , / , . 1 . 1 / 34 42 30 200 beats/min 3 15 L/min 25 100 mL mm Hg mm Hg mm Hg mm Hg 100 130 65 85 95 115 60 40 50 60 1 ( ) 140 159 90 99 123 150 2 ( ) 160 179 100 109 138 170 3 ( ) 180 209 110 119 155 195 4 ( ) 210 120 185 210 ( ) 300 160 230 300 KS P ISO 5840： 2007 13 6.2.2 6.2.2.1 (： , ). .