KS P ISO 10310-2010 Neurosurgical implants－Marking and packaging of implantable neural stimulators《神经外科植入物 可植入神经刺激器的标记和包装》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10310 KS P ISO 10310 :2010 2010 12 24 http:/www.kats.go.krKS P ISO 10310:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2005 12 28 ：2010 12 24 2010-0626 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 10310:2010 i ii .1 1 1 2 .1

2、 3 .3 3.1 .3 3.2 .3 4 3 4.1 3 4.2 3 5 .3 5.1 .3 5.2 3 5.3 4 6 .4 6.1 .4 6.2 .4 6.3 6 6.4 .6 6.5 .7 A() .8 KS P ISO 10310:2010 ii . KS P ISO 10310：2005 . . , , . , , . KS P ISO 10310:2010 Neurosurgical implantsMarking and packaging of implantable neural stimulators 1995 1 ISO 10310, Neurosurgical imp

3、lantsMarking and packaging of implantable neural stimulators , . 1 (, , ) , , , . , . , . (clinician) , RF RF . 2 . 2.1 (neural stimulator) , (, , ) 2.2 (implant pulse generator) , KS P ISO 10310:2010 2 2.3 (programmer), (controller) 2.4 RF (implant RF receiver) (RF) , 2.5 (transmitter), (driver box

4、) RF . . . 2.6 (antenna) RF , RF . 2.7 (cable) , . 2.8 (implant leadextension) RF , 2.9 (connector) 2.10 (adapter) 2.11 () (stimulation) electrode , , () () 2.12 (unit pack) KS P ISO 10310:2010 3 2.13 (multiple pack) 3 3.1 , RF , , . a) / b) c) 5.2 c) 3.2 . 4 4.1 / () . 6. . , . 4.2 . , , . 5 5.1 ,

5、, , . 5.2 . a) b) / c) (“serial number” “SN” ) / d) “use by”, “exp” (/) KS P ISO 10310:2010 4 e) , “STERILE()” f) g) , h) , “for single use ()” i) j) 5.3 . a) / b) ( ) c) 6 6.1 . a) / b) 6.2 6.2.1 / 6.2.2 . 6.2.1 RF a) 1) , 2) b) 1) 2) MRI KS P ISO 10310:2010 5 c) , / (：) d) , 1) , (1/) monophasic b

6、iphasic , , 2) RF , , 6.2.2 a) , / (： ) b) , 1) ( ) , 2) ( ) , KS P ISO 10310:2010 6 3) , , 6.3 , . 6.3.1 a) b) (magnetic), (RF) c) d) , e) 6.3.2 a) b) c) RF d) e) f) ( ) 6.3.3 a) b) c) d) RF e) 6.3.4 a) b) c) 6.4 . KS P ISO 10310:2010 7 . 6.5 , . a) b) c) d) e) , RF / f) g) h) i) KS P ISO 10310:201

7、0 8 A () A.1 . , . . . . . A.2 , . 1 . 4.1 “ (kit)”, . (unit) (kit) . . 6.2.2 b) 2) . . 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 10310 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Neurosurgical implants Marking and packaging of implantable neural stimulators ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr