KS P ISO 9713-2009 Neurosurgical implants－Self-closing intracranial aneurysm clips《神经外科植入物 颅内动脉瘤自闭夹》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 9713 KS P ISO 9713:2009 2009 12 25 http:/www.kats.go.krKS P ISO 9713:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 25 2009-0868 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 9713:2009 .1 1 1 2 1 3 .1 4

2、(Description of aneurysm clips).3 4.1 (Mechanism of action)3 4.2 (Geometry) 3 5 (Indication of dimensions)3 6 (Materials) .3 7 (Determination of magnetic properties) .5 8 (Closing force).6 8.1 (Measurement of closing force of clips)6 8.2 (Tolerance on nominal closing force)6 8.3 (Degradation of clos

3、ing force) 6 9 (Marking of clips) .6 10 (Sterilization) .6 11 (Packaging) 6 12 (Labelling and accompanying documentation)7 i KS P ISO 9713:2009 Neurosurgical implantsSelf-closing intracranial aneurysm clips 2002 2 ISO 9713, Neurosurgical implants Self-closing intracranial aneurysm clips . 1 (頭蓋) , ,

4、 , . . ( ) . 2 . . ( ) . KS P ISO 58322, 2 ： KS P ISO 58323, 3 ： 6 4 KS P ISO 58325, 5 ： KS P ISO 58326, 6 ： KS P ISO 58327, 7 ： KS P ISO 5832 8, 8 ： KS P ISO 14630, KS P ISO 15223, , KS P ISO 16061, 3 . KS P ISO 9713:2009 3.1 (accuracy) “” . 3.2 (aneurysm clip) 3.3 (closing force) 3.3.1 (nominal cl

5、osing force) 3.3.2 (actual closing force) 3.4 (image artifact) , . 3.5 (magnetic properties) 1 . . 2 . 3.6 (magnetic induction) B 1 m2 (T) V sec . 2 2 T . 3.7 MRI (MRI safe) MRI . . 2 KS P ISO 9713:2009 MRI MRI . 3.8 (repeatability) . . , 4 (Description of aneurysm clips) 4.1 (Mechanism of action) 1

6、 . 4.2 (Geometry) ( .) 2 . 5 (Indication of dimensions) . a) b) c) , ( .), , d) . . 3 . . , . 6 (Materials) KS P ISO 5832 2, KS P ISO 5832 3, KS P ISO 58325, KS P ISO 5832 6, KS P ISO 58327 KS P ISO 58328 . . 3 KS P ISO 9713:2009 a) b) c) 1 a) b) c) d) e) f) g) h) J i) ( ) j) k) ： l) 2 ( .) 4 KS P I

7、SO 9713:2009 ：mm b) a) c) d) e) 3 7 (Determination of magnetic properties) , . . , MR . 12. p) . 5 KS P ISO 9713:2009 8 (Closing force) 8.1 (Measurement of closing force of clips) 8.1.1 (Apparatus) 8.1.1.1 , 2 % 1 % . . . . 8.1.2 (Procedure) 8.1.1 a) b) 1 mm (mN) . a) (5. ) 1/3 b) , 2 j) l) . 8.1.3

8、(Test report) . a) b) 8.2 (Tolerance on nominal closing force) 8.1 7.5 % 12. k) . 8.3 (Degradation of closing force) 10 . 5 % . 9 (Marking of clips) KS P ISO 14630 . 10 (Sterilization) KS P ISO 14630 9. . 11 (Packaging) KS P ISO 14630 10. . 6 KS P ISO 9713:2009 , . . 12 (Labelling and accompanying d

9、ocumentation) . a) b) c) d) (, ), e) f) (4.1 ) g) ( 4.2 ) h) , i) j) k) ( 8.1.2 ), ( 8.2 ), 10 5 % (8.3 ) l) 5. ( 3 ) . m) , KS P ISO 15223 “ ” “” n) , , o) KS P ISO 16061 p) MRI MRI q) a) c) 7 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 9713:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Neurosurgical implantsSelf-closing intracranial aneurysm clips ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr