1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5841 2 2： KS P ISO 5841 2:2012 2012 12 27 http:/www.kats.go.krKS P ISO 5841 2:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 6 29 ：2012 12 27 2012-0767 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5841 2:2012 i ii . iii 1
2、 1 2 1 3 .1 4 3 5 .4 6 4 A( ) 5 B( ) 7 C( ) .15 18 KS P ISO 5841 2:2012 ii . , , . , , . KS P ISO 5841 2:2012 iii 2000 2 ISO 5841 2, Implants for surgery Cardiac pacemakers Part 2： Reporting of clinical performance of populations of pulse generators or leads . KS P ISO 5841 2:2012 2： Implants for su
3、rgery Cardiac pacemakers Part 2： Reporting of clinical performance of populations of pulse generators or leads 1 . . A . B . , . C . 2 . . ( ) . ISO 5841 1, Implants for surgery Cardiac pacemakers Part 1： Implantable pacemakers 3 ISO 5841 1 . 3.1 (advisory notification) , , , 3.2 (clinical performan
4、ce period) 3.3 (damaged) KS P ISO 5841 2:2012 2 3.4 (dysfunctional) 3.5 (follow-up centre) , 3.6 (in service) 3.7 (in specification) 3.8 (medical reasons) , , , ( : ) 3.9 (out of service) , . 3.10 (out of specification) 3.11 (population sample) . 3.12 (production group) , , . KS P ISO 5841 2:2012 3
5、3.13 (prophylatic explanation) 3.14 (recommended replacement condition) . 3.15 (registered explant) 3.16 (registered implant) 3.17 (registered implant month) 1 3.18 (reporting party) 4 . a) b) c) . d) . e) . f) . g) ( ) A . h) ( B ). i) , . . , , . , . . KS P ISO 5841 2:2012 4 . . . 5 4. , ( C ). (
6、) A . . B . 1.25 . , . . 6 4. , . , . (B.2.3 ). . . KS P ISO 5841 2:2012 5 A ( ) A.1 . , . C1 C2 A, B, C, D L . . . . A： B： C： C1: C2: D： . . L： . KS P ISO 5841 2:2012 6 A.1 DDLKS P ISO 5841 2:2012 7 B ( ) B.1 . . , , . . . . . . , (5. 6. ). . . . . B.2 B.2.1 . a) b) ( A ) c) . , ( B) , ( C) ( D) .
7、( A), . ( L) . “” , . , ( B). B L KS P ISO 5841 2:2012 8 . , . , . . . , , . B.1 24 . , , . 4 . A A, B, C, D L . A, B, C, D, L 4 . ( ) 4 . B.1 24 . , ( ) . , A . B.3 . ID 1 2 3 4 KS P ISO 5841 2:2012 9 B.2.2 B.2.2.1 , . B.2 . B.1 . B.2 B.1 B.1 . B.2 B.3 B.1 N, A, D, E, C . . . , , N N(t) . . (N)： A
8、(A)： A (D)： D (E)： B L , . ID ( ) KS P ISO 5841 2:2012 10 E(t) B(t) L(t) (B.1) (C)： C , C1 C2 . (U)： 2)()()()()(tEtDtAtNtU+= (B.2) (P)： )()(1)(tUtCtP = (B.3) (S)： )1(.)1()()( PtPtPtS = (B.4) , P(1) P(t) . B.1 ( , C C1 C2 E B L .) (t) (N ) (A ) (D ) (E ) (C ) (U ) (P ) (S ) 1 2 3 4 5 6 7 8 9 10 11 12
9、 13 14 15 16 0 t3 3 t6 6 t9 9 t12 12 t15 15 t18 18 t21 21 t24 24 t27 27 t30 30 t33 33 t36 36 t39 39 t42 42 t45 45 t48 24 24 22 21 20 19 18 18 18 14 11 9 7 4 3 2 0 0 0 0 0 0 0 0 2 2 2 1 2 1 1 2 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 1 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 2 1 0 1 0 0 0 0 24.0 23.0 2
10、2.0 20.5 19.5 18.5 18.0 18.0 17.0 13.0 10.0 8.5 5.5 3.5 2.5 1.0 1.000 0 1.000 0 0.954 5 1.000 0 1.000 0 1.000 0 1.000 0 1.000 0 0.882 4 0.923 1 1.000 0 0.882 4 1.000 0 1.000 0 1.000 0 1.000 0 1.000 01.000 00.954 50.954 50.954 50.954 50.954 50.954 50.842 30.777 50.777 50.686 10.686 10.686 10.686 10.6
11、86 1 13 2 4 5 224.5 B.1 (S) B.3 . KS P ISO 5841 2:2012 11 B.2.2.2 (S) . , (U) , ( , 90%, 95%) . . B.3 B.1 (S) B.2.3 ( B.3 ), . Weibull log-normal . , (t) . i , S(i;t) . )()();(tSitStiS+= (B.5) i O(i;t) . );(1);( tiStiO = (B.6) ( )KS P ISO 5841 2:2012 12 B.3 B.3.1 C . , . B.3.2 . . . , . , . . , ( )
12、. , . , . . , , . . , , , . , . , . B.3.3 , . (life) the Health Industry Manufacturers Association (HIMA) Pacemaker Task Force Satistical Working Group . . “ ” , , , . , , . , . KS P ISO 5841 2:2012 13 C D E 0 1 .(0 1 ) C, D E . CtCtC=)()( (B.7) DtDtD=)()( (B.8) EtEtE=)()( (B.9) C , D E (t) . ( ) , ( ) . , C , D E . , , . . )()()()()()()( tEtDtCtEtDtCt += (B.10) A(t) N(t) (B.7), (B,8) (B.9) . A(t) N(t) . n(t) t N(t) t n(t) N(t) C . =tiinNmax1)()1(
