KS P ISO 7198-2007 Cardiovascular implants－Tubular vascular prostheses《心血管植入物 血管修复术》.pdf

1、 KS P ISO 7198KSKSKSKSSKSKSKS KSKSKS SKSKS KSKS SKS KS KS P ISO 7198： 2007 (2012 ) 2007 10 31 http:/www.kats.go.krKS P ISO 7198： 2007 : ( ) ( ) () ( ) () ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 6 29 ：2007 10 31 ：2012 12 6 ： 20120679 ： (ISO/TC 150) ( 02-509-7294) (http:/www.kats.go.kr). 10 5

2、, . KS P ISO 7198： 2007 i . 1 1 1 2 1 3 .2 4 (general requirement) 5 4.1 (configuration and size designation)5 4.2 (intended clinical use designation) 6 4.3 (materials and construction)6 4.4 (biocompatibility and biostability) 7 4.5 (sterility) 8 4.6 (general information and instructions for use) .8

3、 4.7 (packaging).8 4.8 (marking).9 4.9 (test reports) 9 5 (requirements for finished prosthesis).10 5.1 (visual inspection)11 5.2 , , / , (porosity, water permeability, integral water permeability/leakage, and water entry pressure) 11 5.3 (strength).11 5.4 (length)12 5.5 (relaxed internal diameter)1

4、2 5.6 (pressurized internal diameter) .12 5.7 (wall thickness)12 5.8 (suture retention pressure) 12 5.9 / (kink diameter/radius).12 5.10 (compliance) .13 6 , (requirements for in vivo preclinical and clinical evaluation) 13 6.1 (In vivo preclinical testing) 13 6.2 (clinical evaluation)13 7 (sampling

5、) .14 7.1 (sampling for characterization)14 7.2 (sampling for quality control) .14 8 (test methods for vascular prostheses).14 8.1 (visual inspection, A) .15 8.2 , , / , (determination of porosity, water permeability, integral water permeability/leakage, and water entry pressure) .15 8.3 (determinat

6、ion of strength) 23 KS P ISO 7198： 2007 ii 8.4 (determination of usable length) (A)30 8.5 (determination of relaxed internal diameter) (A).31 8.6 (determination of pressurized internal diameter) (A).32 8.7 (determination of wall thickness) (A).34 8.8 (determination of suture retention strength) (A).

7、35 8.9 (determination of kink diameter/radius) (A) .36 8.10 (determination of dynamic compliance) .37 9 (in vivo preclinical and clinical test methods for vascular prostheses) 38 9.1 , , (trial design, data acquisition and data analysis for in vivo preclinical animal studies) .38 9.2 , , (trial desi

8、gn, data acquisition and data analysis for clinical evaluation).39 10 (information to be recorded and disclosed by the manufacturer on request).42 10.1 (general) 42 10.2 (conformity to general requirements) .42 10.3 (conformity to requirements for finished product) 42 10.4 (conformity to requirement

9、s for in vivo testing and clinical evaluation) .42 KS P ISO 7198： 2007 (2012 ) Cardiovascular implantsTubular vascular prostheses 1998 1 ISO 7198, Cardiovascular implants Tubular vascular prostheses , . 1 1.1 , (shunt) , , . , , , . . , , . , ISO 10993 . . . , . , . 1.2 . . . 1.3 , (National Regulat

10、ory Authority) . , . (patch), (peldget), (stent) . 2 , . . . . IEC ISO . ISO 472： 1988, Plastics Vocabulary ISO 2076： 1999, Textiles Man-made fibres Generic names ISO 2859 1： 1989, Sampling procedures for inspection by attributes Part 1： Sampling plans indexed by acceptable quality level(AQL) for lo

11、t by inspection KS P ISO 7198： 2007 2 ISO 2859 2： 1985, Sampling procedures for inspection by attributes Part 2： Sampling plans indexed by limiting quality(LQ) for isolated lot inspection ISO 2869： 1973, Surface active agents Detergents Anionic-active matter hydrolyzable under alkaline conditions De

12、termination of hydrolyzable and non-hydrolyzable anionic-active matter ISO 2960： 1974, Textiles Determination of bursting strength and bursting distension Diaphragm method ISO 5081： 1977, Textiles Woven fabrics Determination of breaking strength and elongation(Strip method) ISO 5084： 1996, Textiles

13、Determination of thickness of textiles and textile products ISO 10993 1： 1997, Biological evaluation of medical devices ISO 14155： 1996, Clinical investigation of medical devices ASTM D 76 93, Specification for tensile testintg machines for textiles ASTM D 123 94, Terminology relating to textiles 3

14、ASTM D 76 93, ASTM D 123 94 . 3.1 (allograft) 3.2 (bifurcation) 3.3 (biological material) . . 3.4 (biostability) , 3.5 (coating) (substrate) , , . 3.6 (compliance) 3.7 (component) KS P ISO 7198： 2007 3 3.8 (composite prosthesis) 3.9 (compound prosthesis) 3.10 (configuration) , , 3.11 (construction)

15、3.12 (crimp) , 3.13 (fibril) (node) , 3.14 (host) 3.15 (implantable state) . (3.20) . . 3.16 (integral water permeability) , 3.17 (leakage) , 1 . 2 (3.19) . KS P ISO 7198： 2007 4 3.18 (node) 3.19 (prosity) 1 , % . 2 (3.17) (3.34) . 3.20 (preclotting) , 3.21 (primary component) 3.22 (prosthesis) 3.23

16、 (residual material) 3.24 (secondary component) , 3.25 (substrate prosthesis) 3.5 3.26 (synthetic material) (： ) . 3.27 (synthetic nontextile prosthesis) KS P ISO 7198： 2007 5 3.28 (synthetic textile prosthesis) 3.29 (usable length) . 3.30 (vascular prosthesis) 3.31 (velour) 3.32 (void) . 3.33 (wate

17、r entry pressure) 3.34 (water permeability) 1 16 kPa(120 mmHg) mL cm-2 min-1 . 2 (3.19) . 3.35 (xenograft) 4 (General requirement) . 4.1 (Configuration and size designation) (： , , ). KS P ISO 7198： 2007 6 . 4.1.1 (Uniform straight vascular prosthesis) . a) (mm) b) 10 % , 16 kPa(120 mmHg) (mm) c) (c

18、m) 4.1.2 (Bifurcated uniform vascular prostheses) (cm) (cm) . 4.1.1(b). 4.1.3 (Tapered vascular prostheses) (cm) (cm) . 4.1.1(b). 4.1.4 (Other configuration) , , , , mm cm . 4.2 (Intended clinical use designation) . a) , b) , , c) d) e) f) 4.3 (Materials and construction) 4.3.1 (Classfication) . a)

19、b) c) (： , ) d) (compound) e) (composite) KS P ISO 7198： 2007 7 4.3.2 (Nomenclature) 4.3.2.1 (Synthetic materials) . a) ISO 472 ISO 2076 b) 4.3.2.2 (Biological materials) . a) b) (： , ), (： , ) c) d) (： ) 4.3.2.3 (Coatings) , , . . a) 4.3.2.1 b) 4.3.2.2 4.3.2.4 (Storage fluids) . a) b) . 4.3.2.5 (Re

20、sidual chemicals) , (3.15 ). , . 4.4 (Biocompatibility and biostability) 4.4.1 (Biocompatibility) ISO 10993 1 . . . KS P ISO 7198： 2007 8 4.4.2 (Biostability) , . . , . a) b) c) 4.5 (Sterility) . . 4.6 (General information and instructions for use) , . . a) b) , , c) (： , ) d) 1 , (STERILE DO NOT RE

21、STERILIZE SINGLE USE ONLY) e) f) g) h) 4.7 (Packaging) 4.7.1 (Unit container) , . , , , . 4.7.2 (Outer container) . . 4.7.3 (Shipping container) , , . KS P ISO 7198： 2007 9 4.8 (Marking) 4.8.1 (Container label) , . a) , , b) . . c) (4.1) (：| = , = ) d) (5.4) e) (5.5) f) (5.6) g) , , / , (5.2) h) 1 ,

22、 , (4.5) i) (lot number) j) (sterile lot number) . k) , l) , m) n) o) 4.8.2 (Record label) , . . a) b) c) / d) ( ) 4.9 (Test reports) , . 4.9.1 (General) , . . a) b) c) d) KS P ISO 7198： 2007 10 e) f) . 4.9.2 (Additional information) . a) 4.3 b) c) 4.1, 4.1.2, 4.1.3, 4.1.4 d) e) f) g) h) 5 (Requirements for finished prosthesis) 1 . 1 . .