Reuso Dispositivosen Odontologia Claudia Barrantes

7/18/2019 Reuso Dispositivosen Odontologia Claudia Barrantes

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2

CONSULTORIO ODONTOLOGICOMIGUEL ANGEL CASTAÑO ANTIA

Cód:

MREUDISOD

Versión: 01

MANUAL REUSO DE DISPOSITIVOS ODONTOLOGICAS Fecha:

Enero de

2013.

CONTENIDO

Pág.

RESUMEN 5

INTRODUCCIÓN 6

1. PLANTEAMIENTO DEL PROBLEMA 7

2. JUSTIFICACIÓN 8

. OBJETIVOS !

.1 OBJETIVO GENERAL !

.2 OBJETIVOS ESPECIFICOS !

". MARCO TEORICO 10

".1 ETICA DEL REUSO 10

".2 RESEÑA #ISTORICA 10

". RACIONALIDAD 11

"..1 R$%&'() *$+$ R(,)$+ 11

"..2 R$%&'() *$+$ D()(-$+ 12

".. E/(-0&) ( +(,)& ( &) D3)*&)3034&) 12

".." R(-&('$-3&'() 1

".5 REUISITOS DE CALIDAD PARA LA ESTERILIACIÓN DELOS DISPOSITIVOS ODONTOLOGICOS 1

".5.1 E4$,$-3' ( D3)*&)3034& 1

5.0 POSICIÓN TECNICA DE LA ANDI, CON RESPECTO ALREPROC ESAMIENTO DE DISPOSITIVOS MEDICOSDISEÑADOS PARA UN SOLO USO 1"

5.1 A)*(-0&) 3'4&,-+$&) (' ( R(,)& 15



2

5.1.1 C&')3(+$-3&'() T9-'3-$) 15

5.1.2 P+&:($) 09-'3-&) ;,( *,((' *+()('0$+)( (' ( R(*+&-()& 17

6.0 REGLAMENTACIÓN VIGENTE 18

6.1 DECRETO "725 DEL 2005 18

6.1.2 D3)*&)3034&) M93-&) *$+$ ,)& ,$'& 18

6.1. C$)3/3-$-3' ( D3)*&)3034&) )(g<' ( R3()g& 1!

6.1." C+30(+3&) ( C$)3/3-$-3' 20

6.1.5 E;,3*& B3&93-& 20

6.1.6 E;,3*& B3&93-& R(*&'0('-3$& 22

6.1.7 R(*&0('-3$3('0& 22

6.1.8 R(;,3)30&) *$+$ $ $,0&+3%$-3' ( 3*&+0$-3' (E;,3*& B3&93-& +(*&0('-3$& 22

6.2 DECRETO "562 DE 2006 =P$+ág+$/& A+0.86> 2

6. BUENAS PRACTICAS DE MANOFACTURA ? CERTIFICADOS DE ALMACENAMIENTO ? ACONDICIONAMIENTO DE LOSDISPOSITIVOS MEDICOS 2"

6." INSTITUCIONES INVOLUCRADAS EN EL CONTROL ?VIGILANCIA DE LOS DISPOSITIVOS MEDICOS 2"

7.0 RESOLUCIÓN 1@" DE 2006 25

7.1E)0$'$+ N& " M(3-$('0&) D3)*&)3034&) M93-&) 25

7.2 C+30(+3&) 258.0 CLASIFICACIÓN DE DISPOSITIVOS MEDICOS

SEGN CATEGORIA DE RIESGO SANITARIO 27

!.0 ESTRATEGIAS PARA EL CONTROL DEINFECCIONES EN ODONTOLOGA 28

!.1 O:(034&) ( -&'0+& ( 3'/(--3&'() (' &&'0&&g$ 2!

!.1.2 C&'3-3&'() /$4&+$:() *$+$ 0+$')3)3' (

E'/(+($() 3'/(--3&)$) 2!

!.1.2. F,('0() ( 0+$')3)3' ( 3'/(--3&'() 0



!.2 CLASIFICACIÓN DE LOS INSTRUMENTOS ODONTOLOGICOSDIFERENTE A LA CLASIFICACIÓN DE RIESGO SANITARIO 2!

!.2.1 I')0+,('0& ()(-$:( ( ,)& <'3-& 1

!. METODOS DE ESTERILIACIÓN O DESINFECCIÓNDE INSTRUMENTOS DENTALES 1

!..1 D()3'/(--3' 1

!." NIVELES DE DESINFECCIÓN 2

!.".1 D()3'/(-0$'0( 2

!.".2 G(+3-3$

!.". E)0(+33%$-3'

!."." E)09+3

!.5 MANEJO DEL INSTRUMENTAL EN ODONTOLOGIA

!.5.1P+&-(33('0& *$+$ ( 0+$0$3('0& ( 3')0+,('0$ 5

1@. INSTRUCTIVO PARA EL REGISTRO DE DISPOSITIVOSMEDICOS, ODONTOLOGICOS O MATERIALES ? EUIPOS !

11. DISEÑO METODOLOGICO "2

11.1 TIPO DE ESTUDIO "2

11.2. POBLACIÓN "2

11. GESTIÓN DEL DATO "2

11." VARIABLES "2

11.5 OPERACIONALIACIÓN DE VARIABLES "

11.6 PLAN ? PROCESAMIENTO DE LA INFORMACIÓN "

12. RESULTADOS ""

1 CONCLUSIONES "5

GLOSARIO "6

BIBLIOGRAFA "8



RESUMEN

L&) 3)*&)3034&) ( ,)& &&'0&g3-& *,((' *+&,-3+ $& *&0('-3$ 0$'0& $*$-3('0( -&& $ &*(+$&+ . D( 3g,$ /&+$ )( *,(( *+()('0$+ ,' (4('0&$4(+)&, ( -,$ $-( +(/(+('-3$ $ ,' +(),0$& -'3-& 3/(+('0( $ ()*(+$&(:3& $ ,' (++&+ ,+$'0( ( 3$g')03-&, 0+$0$3('0& & -,3$& ( *$-3('0( '& $ -,+)& '$0,+$ ( $ ('/(+($ & $ -&'3-3&'() *+&*3$) ( $ 3)$ &)(4('0&) $4(+)&) )( *,((' *+(4('3+ ,)$'& (3$) +$%&'$:().

S3 :3(' &) $0(+3$() 3)*&)3034&) ('0$() (:(' -,*3+ -&' -3(+0$)*+&*3($() *$+$ *&(+ )(+ ,033%$&) (' ,$'&) 0$() -&&H )(+ 3'&-,&)0('(+ ,' 03(*& ( ,)& $(-,$&, )(+ :3&-&*$03:(), (0-.

E3)0( $ *&)3:33$ ( ;,( $g,'$) ( ()0$) *+&*3($() '& )( -,*$', $)($ *&+ /$$) (' $ $'3*,$-3', *&+ '& 0&$+)( $) (:3$) *+(-$,-3&'() &*&+ ( $:,)& ( +(,033%$-3' ( -3(+0&) $30$('0&).

T&$) ()0$) *&)3:33$() ( +3()g& *,((' *+()('0$+)( $<' -&' &)$0(+3$() á) -&<'('0( ,033%$&) ( $+-$) -&(+-3$() , -&'&-3$)( 3'-,)&, $-(*0$&) $*+&:$&) *&+ $) &+g$'3%$-3&'() -&'0+&$&+$) -&&)&'H

L$ F((+$-3' D('0$ I'0(+'$-3&'$ =F.D.I.>, O+g$'3%$-3' ( E)0$'$+3%$-3'

I'0(+'$-3&'$ =I.S.O.>, $ A)&-3$-3' D('0$ A(+3-$'$ =A.D. A.>, ;,( $*+,(:$'&) $0(+3$() *&+;,( -,*(' -&' -3(+0$) '&+$) 09-'3-$) :3&g3-$)(3g3$) *&+ (&).

L& ;,( )( ()*(+$ (' ,' /,0,+& -&' +()*(-0& $ +(,)& ( &) 3)*&)3034&)&&'0&g3-&) () $ -+($-3' ( ,'$ -,0,+$ 3')030,-3&'$ (' )(g,+3$ (*$-3('0(, $ 3*(('0$-3' ( *+á-03-$) )(g,+$) ( 0+$:$& -&'03',& *$+$ ((&+$3('0& ( &) /$-0&+() ,$'&), $) *&(+ +($3%$+ $-0&) -'3-&) á))(g,+&) ;,( )( $((' ( &) (++&+() ;,( ),-((' $ 3$+3& (' $)&+g$'3%$-3&'() ( )$,.



INTRODUCCION

E 0(+3'& 3)*&)3034&) 93-&) (/3'( 3')0+,('0&) $*$+$0&) $0(+3$() (,)& (3-& &&'0&g3-&, *$+$ )(+ ,)$&) )&&) & (' -&:3'$-3' )(+ $*3-$&) (' )(+() ,$'&) ()03'$&) *+3'-3*$('0( $ 3$g')03-&*+(4('-3' $343& ( ('/(+($().

L&) 3)*&)3034&) 93-&) +(,033%$&) *,((' -$,)$+ (/(-0&) '&-34&) *&+ *+&:($) ( /,'-3&'$3('0&. E' $ $-0,$3$ '& )( 3)*&'( ( $0&)()0$)03-&) $-(+-$ ( 0$() (/(-0&), *(+& $ $&+$ ( &) *$)() (' 43)0$ (()0&) *(3g+&) 3'(+('0() $ ,)& ( ()0&) ((('0&) $' *+&,g$& (()*$+$ -&'0+&$+&) , '& $ ,$ ( ;,( )( +(;,3(+( ,' $&+ -&'0+& )&:+( &)3)*&)3034&) 93-&) 0$'0& -&' $ $*3-$-3' ( (() +(g$('0$-3&'() *&+ *$+0( ( $) ('03$() )$'30$+3$), -&& )&' )3)0($) ( 43g3$'-3$ $(-,$&),+$'0( ( *+&-()& ( -&(+-3$3%$-3' &'( (:(' *$+03-3*$+ $)$,0&+3$() )$'30$+3$) &) /$:+3-$'0() &:43$('0( &) ,),$+3&) 3+(-0&) &)*$-3('0().

E /$:+3-$'0( ( ()0&) ((('0&) ( ,)& (3-& &&'0&g3-& (:( )(+ *('$('0( ( +()*&')$:( ( $ -$3$, $ ;,( ()0( (:( )(+ 3)($& -+($&, ,'0& -&' ( *+&,-0&, $*&+0$'& ,'$ g,$ ( $'(& (' -,$'0& $

,+$-3' 03(*&) ( +(,033%$-3', :$)$&) (' (43('-3$) -3('0/3-$) ;,(*(+30$' &:0('(+ )(g,+3$ (/3-$-3$.

A) &) *+&-()&) *+&,-034&) ;,( 3'-,(' ()( $ )((--3' ( $0(+3$)*+3$) $)0$ $ 3:(+$-3' $ (+-$& ( ,' *+&,-0& )( (:(' )&(0(+ $+3g,+&)&) *+&-()&) ( -&'0+& ( -$3$, *$+$ $)(g,+$+ ;,( ( *+&,-0& /3'$-,*$ -&' $) ()*(-3/3-$-3&'() ( -$3$ 3)($$).

#& (' $ &) /$:+3-$'0() 3'0(+'$-3&'$() ()0á' $*3-$'& (' ( *+&-()& (/$:+3-$-3' $) '&+$) ISO, (' *$+03-,$+ $ '&+$ ISO !0002000, ;,( )(+(/3(+( $ )3)0($ ( -$3$. ,( () $ '&+$ *&+ (-(('-3$ ((g3$ *$+$

$)(g,+$+ $ -$3$.

D3/(+('0() *$)() )( $' *+(&-,*$& ( (g3)$+ (' ()0$ $0(+3$ -$)3/3-$' $&) 3)*&)3034&) ( $-,(+& $ +3()g& -&*(3$.

E &:(034& ( 3-$ -$)3/3-$-3' ()0$ ('/&-$& $ ((+-(+ 3/(+('0() -&'0+&()*$+$ -$$ ,'& ( (&) 0('3('0( $ 3'33%$+ +3()g&) ( *+&,-3+ $& &('/(+($ &0&+g$+ )(g,+3$ (/3-$-3$ $ &) ,),$+3&).



1 PLANTEAMIENTO DEL PROBLEM A

KC,$ )&' &) *+3'-3*$() 3'-3('0() $4(+)&) ;,( )( *+()('0$' -&' ( +(,)&( &) 3)*&)3034&) &&'0&g3-&) K$ -$3$ ( &) 3)*&)3034&) &&'0&g3-&))( 3'4&,-+$' (' $ $*$+3-3' ( &) (4('0&) $4(+)&) KC,$() 3)*&)3034&)&&'0&g3-&) +(,033%$&) )( +($-3&'$' -&' &) (4('0&) $4(+)&)



2JUSTIFIC ACION

L$ 3'/&+$-3' ;,( ()0( ()0,3& $++&( () ( g+$' $*&+0( -3('0/3-&, *$+$ (á+($ ( $ &&'0&&g$. ?$ ;,( () 3*&+0$'0( ;,( (' 3-$ á+($ (3)0$ ,'-&'&-33('0& (0$$& $-(+-$ ( +(,)& ( &) 3)*&)3034&) &&'0&g3-&) ( &) (4('0&) $4(+)&) ;,( ()0&) g('(+$', $(á) ( $) *&)3:() /&+$) ($'(& *$+$ 3)3',3+&).

E)0( 0+$:$& (43('-3$ ,'$ +(43)3' :3:3&g+á/3-$ $-0,$3%$$ *$+$ +(-&*3$+ $$&+ 3'/&+$-3' *&)3:( )&:+( ( +(,)& ( 3)*&)3034&) &&'0&g3-&).



OBJETIVOS

.1 OBJETIVO GENER AL

R($3%$+ ,'$ +(43)3' :3:3&g+á/3-$ ( $-(+-$ ( +(,)& ( &) 3)*&)3034&)&&'0&g3-&).

.2 OBJETIVOS ESPECIFICOS

D(0(+3'$+ $) +$%&'() *$+$ ( +(,)& ( 3)*&)3034&) &&'0&g3-&).

C$)3/3-$+ &) 3)*&)3034&) &&'0&g3-&) ( $-,(+& $ $ -$)( ( +3()g&.

A'$3%$+ $ 3*&+0$'-3$ ( $ 903-$ ( +(,)& ( &) 3)*&)3034&)&&'0&g3-&).



9

E)0$:(-(+ ,' *&)3:( /&+$0& *$+$ $) IPS ;,( *(+30$' $ 4(+3/3-$-3' (+(,)& ( &) 3)*&)3034&) &&'0&g3-&) )&*&+0$& (' (43('-3$) -3('0/3-$)

".@ MARCO TEORICO

".1 ETICA ? REUSO

".2 RESEÑA #ISTORIC A

E +(,)& ( 3)*&)3034&) -&('% $+((&+ ( 20 $&) $0+á) )3('& á)(43('0( *$+$ =93-&) &&'0&g&) ('/(+(+$) (0-.> (' &) <03&) 7$&) :$)á'&)( (' $ -&'0('-3' ( -&)0&) /$0$ ( +(-,+)&). D(:3& $

$ '(-()3$ ( $0$ +&0$-3' ( 3')0+,('0$ (' $) 3/(+('0() á+($) (*+()0$-3' ( )(+43-3&) ( )$,, -&' ( &:(034& ( -,*3+ $) (0$) ($0('-3' $ ,),$+3&) ()0$:(-3$) *&+ $) 3')030,-3&'(). =1>E) ( ),$ 3*&+0$'-3$ (/3'3+ 0('(+ -$+& -3(+0&) -&'-(*0&) 0$() -&&H

ETICA

E) $;,($ 3')0$'-3$ ()( $ -,$ ,%g$&) 4$&+$&) $ /&+$ -&& ( (-& , )( -&*&+0$ ( &:+(, $ 3)& 03(*& $ 3')0$'-3$ ()( $-,$ /&+,$&) *+3'-3*3&) -+30(+3&) $-(+-$ ( -& (:(&)-&*&+0$+'&) $-3$ &'( (:(&) 3+3g3+ ',()0+$ $--3'.

C&& -3('-3$ )&-3$ '& *,(( $*+&4(-$+ )3(*+( $) 4('0$$) 09-'3-$)-,$'030$034$) *$+$ 3'4()03g$+ (3+ +(),0$&) *,() (' $) -&',-0$) (&) &:+() ()*(-3$('0( (' ( á:30& ( $) -&',-0$) &+$() $,-& ( 4$&+() ()*3+30,$() -&'3-3&'() *+3'-3*3&) 43+0,() ;,( '& ()*&)3:( (3+ . E)0$) -&',-0$) )($$' $ '($ ($+-$0&+3$ ('0+( & 3-30& & 3-30& & -&++(-0& & 3'-&++(-0& & $-(*0$:( & 3'$-(*0$:(

BIOETICA

E) $ 3)-3*3'$ ;,( *$'0($ $ $ (3-3'$ ,' ',(4& *($& &+$.T(+3'&&g3-$('0( () 3$ ( B3&) E03(, -&'-(*0,$('0( )'0()3) (-3('-3$ -&'-3('-3$.



E)0$ () *&+ (/3'3-3' ( ()0,3& ( $ -&',-0$ ,$'$ (' ( á+($ ( $-3('-3$ ( $ 43$ $ $0('-3' ( $ )$, (' $ (3$ ;,( 3-$-&',-0$ () ($3'$$ $ $ ,% ( &) *+3'-3*3&) 4$&+() &+$().

ETICA MEDICA

L$ *+$-03-$ ( $ (3-3'$ ;,( () ( $+0( ( -,+$+ $ &) ('/(+&) )3g'3/3-$*$+$ ( *+&/()3&'$ ( $ )$,, ( (:(+ ( ()*(g$+ ,'$ $-0343$09-'3-$('0( *(+/(-0$ )&(0(+)( $ $ 3)-3*3'$ 903-$. #$-( +(/(+('-3$ $$ &+$ ;,( &+3('0$ $ $) $--3&'() ( &) &:+() $ /3' ( ;,( 434$' (,'$ $'(+$ 3g'$.

L$ 903-$ *+&/()3&'$ () 3*&+0$'0( $ ;,( -&'-3(+'( )3' ,$ $ ,'$$-0,$-3' ,$'$, -&*+&3)& )&-3$ () ,' 4$&+ -,0,+$.

". R ACION ALID AD

E) ,'$ -$*$-3$ ,$'$ ;,( *(+30( *(')$+ , (4$,$+ $-0,$+ ( $-,(+& $-3(+0&) *+3'-3*3&) *$+$ *&(+ )$03)/$-(+ $g<' &:(034& & /3'$3$, &:0('3('&$) &) (&+() :('(/3-3&) (-&'3-&).

"..1 RAONES PARA REUS AR

L$ +(,033%$-3' ( &) 3)*&)3034&) (' ',()0+& (3&, () 43)0$ -&& ,'$4('0$$ (-&'3-$, ()0+$09g3-$ &+g$'3%$034$. D('0+& ( $) +$%&'() $)+((4$'0() *$+$ +(,)$+ ('-&'0+$&) H

1- -&)0& ( *+&1,-0& '& ( )(+43-3&, $ ;,( () ,-& $) (-&'3-& $*+()0$-3' ( )(+43-3& ;,( '& $ $;,3)3-3' ( 3)*&)3034&) *&+ -$$*+&-(33('0& +($3%$&.

2 P+(),*,()0& '& )( -,('0$ -&' ,'$ :,('$ *$'3/3-$-3' -&'0+& ('09+3'&) (-&'3-&) /3'$'-3(+&).

- C,0,+$ ( +(,)& '& (3)0( ,'$ *&03-$ (,-$034$ ( -$*$-30$-3' &034$-3', ;,( g$+$'03-( ,'$ :,('$ -$3$.

"- D3)*&'3:3231$1 ( &) 13)*&)3034&).



"..2 RAONES PARA DESEC#AR

S( (:( (33'$+ & +(-$%$+ 0&&) $;,(&) 3)*&)3034&) ;,( '& -,*(' -&'$) -&'3-3&'() '(-()$+3$) *$+$ )(+ +(,033%$&) $ ;,( ()0& g('(+$H

1- A,('0& ( -&)0& ( )3)0($, *&+ -&*3-$-3&'().

2- *&-$) g$+$'0$) (' ( *+&-()& ( $)(*)3$.

- G$+$'03%$+ $ /,'-3&'$3$.

"- G$+$'03%$+ $ :3&-&*$03:33$.

5- D3/3-,0$ ( +(*+&-()& ( &) 3)*&)3034&).

6- *&-$ /3$:33$ (' ( /,'-3&'$3('0& ( &) 3)*&)3034&).

".. EFECTOS DEL REUSO DE LOS DISPOSITIVOS

L$ +(,033%$-3' ( &) 3)*&)3034&) ( ,' )&& ,)& *,(( g('(+$+ <03*()(/(-0&) $ '34( ( $ 3')030,-3', *$-3('0(, *+&/()3&'$ ( $ )$,.

D3-&) (/(-0&) )&' H

1- A/(-0$ $ (;,3$ ( &) *$-3('0().

2- A/(-0$ $ )(g,+3$ ( *$-3('0( ( &*(+$&+ .

- A,('0$ &) -&)0&) (' )$, *&+ -&*3-$-3&'().

"- D(0(+3&+$ ( *+&,-0& )$'30$+3& )3 $ /$$).

5-V,'(+$:33$ ( &) (+(-&) ( *$-3('0().

6- I++(g,$+3$ 3/3-,0$ (' &) -&:+&).

7- L$ 3')030,-3' $-(*0$ $ 3)$ +()*&')$:33$ (g$ ;,( 03('( ( /$:+3-$'0(O+3g3'$.

8- (*&)3-3' $ ($'$) (3-$) (g$() *$+$ &) *+&/()3&'$().

!- S( 0&+'$ ,'$ 3')030,-3' *&-& -&'/3$:( *$+$ &) ,),$+3&).



".." RECOMENDACIONES

1- C$)3/3-$+ &) $+0-,&) ( ,' )&& ,)& ( $-,(+& $ +3()g& $)&-3$& $,)&.

2 C+($+ ,' -&309 ( 903-$ -&' $ +(*+()('0$-3' ( *+&/()3&'$() (()0$'$+3%$-3' $:$)0(-33('0& /&+$-3'.

- I'0(g+$+ $ *+&/()3&'$ ( $ -('0+$ ( 3'),&) *$+$ (/3'3+ $) -&*+$) ($-,(+& $ $ 0(-'&&g$ ( +(*+&-()& 3)*&'3:(.

"- A-0,$3%$+ $'0('(+ ,' )3)0($ ( -&)0&) (' $ -('0+$ ( ()0(+33%$-3'.

5- D3)($+ ,' *+&0&-&& $3'3)0+$034& *$+$ $ )&3-30, (4$,$-3' ( +(,)&( 3)*&)3034&) 93-&).

".5 REUISITOS DE CALIDAD PARA LA ESTERILIACION DELOS DISPOSITIVOS ODONTOLOGICOS

P$+$ *+(4('3+ ( +3()g& ( 3'/(--3' &*033%$+ $ -$3$ ( *+&-()& (

()0(+33%$-3' )( (:( 0('(+ (' -,('0$H

1- L&) 3)*&)3034&) (:(' )(+ ()$+03-,$:() & &3/3-$:().

2-S(+ +()3)0('0() *$+$ *&(+ )(+ ),(+g3&) (' )&,-3&'() ;,3-$) &('%3á03-&).

- C&')(+4$+ *+()('0$+ ( (*$;,( &+3g3'$ (' ( -,$ )( $-+(30$ ( 90&&( ()0(+33%$-3' ,033%$&.

"-,( ( 90&& ( ()0(+33%$-3' ( /á:+3-$ )($ -&*$03:( -&' ( 90&& (()0(+33%$-3' &-$.

".5.1 EVALUACION DEL DISPOSITIVO.

1- T3*& ( 3)*&)3034&.

2- C$)3/3-$-3' ( +3()g&.

- C$+$-0(+)03-$) ( $0(+3$.



"- C$+$-0(+)03-$) ( 3)(& ( 3)*&)3034&.

5- C&'3-3&'() ( 3'g+()& ( &) 3)*&)3034&) $ $ 3')030,-3'.

6- P+&-()$3('0& 3'3-$& *$+$ ( $0(+3$.

7- C&)0& ( 3)*&)3034&.

8- A,0&+3%$-3' ( (4$,$&+ .

!- A,0&+3%$-3' ( +(,)&.

5.@ POSICION TECNICA DE LA ANDI CON RESPECTO AL REPROCESAMIENTO DE DISPOSITIVOS MEDICOSDISEÑADOS PARA UN SOLO USO

L$ S$, (' C&&:3$ -&& (' $ g+$' $&+$ ( *$)() ( ,'&, )( $43)0& *+()3&'$$ (' &) <03&) $&) *&+ ( $,('0& (' &) -&)0&) ( $$)3)0('-3$ (:3& *+3'-3*$('0( $ $ 0+$')3-3' (&g+á/3-$ (*3(3&g3-$()03&) ( 43$ '& )$,$:() $&+() '34(() ( ('/(+($() -+'3-$) (3'-$*$-30$'0() '&4($() 0(+$*9,03-$) 0(-'&&g$) $*3$-3' (-&:(+0,+$) ( $)(g,+$3('0& &(&) 3'$(-,$&) ( g(+('-3$3('0& ( $$0('-3' (' )$, (' /3', ,-&) &0+&) $)*(-0&) ;,( $' g('(+$& *+()3'(' & ;,( &) (*(+0&) ('&3'$' ( g$)0& g&:$ (' )$,.=2>

F+('0( $ ()0&) 0($) $;,(&) *+&*3&) ( $) (-&'&$) 3'á3-$) ((+-$&, $ I',)0+3$ ( 3)*&)3034&) 93-&) (' C&&:3$, $ 0+$:$$&3'0(')$('0( (' $ :<);,($ ( $0(+'$034$) ;,( )($' -$$ $ á) -&)0&

(/(-034$) -&'-(*0& ;,( 3)0$ ,-& ( $;,( *+&*,()0& *&+ $g,'&) (' ( ;,()( $),( ;,( $ (/(-0343$ ( $) 3'0(+4('-3&'() () 3'(*('3('0( ( -&)0&(' &0+$) *$$:+$) & ;,( )( -&'&-( -&& -&)0&-3'33%$+ ;,( '& () á) ;,($),3+ ;,( $;,(& ;,( () & Q('&) -&)0&)&Q () & (&+ .

L$) -&*$$) +(*+()('0$$) (' ()0$ -á$+$, )&' /$:+3-$'0() ( D3)*&)3034&)M93-&) *$+$ ,' S&& U)& =DMSU>, ;,( *&+ (/3'3-3' ()0á' 3)($&) *$+$)(+ ,033%$&) ,'$ )&$ 4(% (' ,' <'3-& *$-3('0(. E +(*+&-()& +(,)& (DMSU () ,' *+&:($ ;,( 3'4&,-+$ $)*(-0&) ( 3/(+('0( -&*(3$. E

+(,)&, (' ()0( -&'0(0&, () (/3'3& -&& ( ,)& ( ,' 3)*&)3034& 93-& á)4(-() ;,( $) ()*(-3/3-$$) *&+ ( /$:+3-$'0( (' $ (03;,(0$. E)0$ *+á-03-$'&+$('0( ()0á *+(-(3$ *&+ ( +(*+&-()$3('0&, ;,( 3'-,( 0&&) &)



*$)&) +($3%$&) *$+$ -&'4(+03+ ,' 3)*&)3034& ( ,' )&& ,)& -&'0$3'$& (',' 3)*&)3034& 3)0& *$+$ )(+ ,)$& (' ,' *$-3('0(. L$) (0$*$) *,((' 3'-,3+('0+( &0+$) 3*3(%$ *+,(:$) ( /,'-3&'$3$ +((*$;,(0$3('0&(03;,(0$&, ()3'/(--3' ()0(+33%$-3'. R(*+&-()$+ ,' 3)*&)3034& 93-& ;,(

$ )3& 3)($& (03;,(0$& *$+$ )(+ ,)$& ,'$ )&$ 4(%, -+($ ,' ',(4&3)*&)3034&.

E (-3+ QS&& *$+$ U' U)&Q & ), (;,34$('0( () *$+0( ( $ (03;,(0$ (3)*&)3034&. #$ ,'$ 3')0+,--3' ()*(-3/3-$ ( '& +(*+&-()$+ +(,)$+ (3)*&)3034& ()*,9) ( ), ,)& 3'3-3$. A;,(&) ;,( 3g'&+(' ()0$ 3')0+,--3'()0á' ,033%$'& ( 3)*&)3034& ( /&+$ -&'0+$+3$ $ & ()0$:(-3& *&+ (/$:+3-$'0( &+3g3'$ *&+ & 0$'0& (:(' 0&$+ $ +()*&')$:33$ ( ()(*(&( 3)*&)3034&.

E +(*+&-()& +(,)& -&'(4$' ( +3()g& ( 3'/(--3' -+,%$$ -&*+&(0( (()(*(& ( 3)*&)3034&. L$) (3$) '(-()$+3$) *$+$ 4$3$+ 3-&+(*+&-()$3('0& +(,)& )&' (0(')$) -&*($) /+(-,('0(('0( *&-&('0('3$). E) -,()03&'$:( )3 ,' *$-3('0( ;,( (g$)( $ ('0('(+ 0&& ()0(*+&-(33('0&, *,3(+$ $+ ), -&')('033('0&.

L$ 3',)0+3$ ( /$:+3-$'0() ( 3)*&)3034&) 93-&) $ (3-$& ,-&) $&) $$ 3'4()03g$-3' ()$++&& ( 3)*&)3034&) 93-&) (/(-034&) ;,( )$03)/$g$'$) '(-()3$() ( &) 0+$:$$&+() ( $ )$, ),) *$-3('0(). L$*+(&-,*$-3' '& )&$('0( -&*+('( &) $)*(-0&) 09-'3-&) (g$()-&<'('0( 3)-,03&) (' ( á:30& 3'0(+'$-3&'$ )3'& ;,( 0+$')-3('( $ $)-&')(-,('-3$) ;,( ()0$ *+á-03-$ *&+$ 0+$(+ , (' $) -&'3-3&'() ;,($-0,$('0( /,'-3&'$' $) -('0+$() ( ()0(+33%$-3' ( $ $&+$ (3')030,-3&'() ( )$, ( *$).

5.1 ASPECTOS INVOLUCRADOS EN EL REUSO

5.1.1 C&')3(+$-3&'() T9-'3-$)H

E 3)(& ( *+&,-0& $ )((--3' ( $0(+3$() )&' ( +(),0$& (

()0,3&) (0$$&) ( /$-0&+() +((4$'0() *$+$ $ )(g,+3$ ( *$-3('0( $ /$:+3-$-3' -&)0&(/(-034$ ( 3)*&)3034&. L$) *+&*3($() /)3-$) ( ,'3)*&)3034& 93-& ,'0& -&' ), /,'-3&'$3('0& (/(-0343$ )&'



3'4()03g$$) ()$++&$$) *+&:$$) *&+ ( /$:+3-$'0(. E+(*+&-()$3('0& *$+$ ( +(,)& *,(( $/(-0$+ ()0$) -$+$-0(+)03-$) =E.H+()3)0('-3$ ( $0(+3$, 3(')3&'() /(3:33$, $()34&) ,:+3-$'0()(0-.>

L$ ()0(+33$ ( ,' 3)*&)3034& 93-& )&& *,(( )(+ g$+$'03%$$ :$& ,'*+&-()& ( 4$3$-3' -&'0+&$&. L&) /$:+3-$'0() ,033%$' )3)0($) (-$3$, $:3('0() ( /$:+3-$-3' ()*(-3$() (;,3*&) -(+03/3-$&) *+&-()&);,( )&' 4$3$&) *+,(:$) ( 3'0(g+3$ ( (*$;,( 90&&) ($)(g,+$3('0& ( $ ()0(+33$ -&'0+& ( *+&-(33('0& ( (03;,(0$&.S,) 90&&) ( -&'0+& 0$:39' ()0á' ),(0&) $ 3')*(--3' +,03'$+3$ *&+ *$+0( ( $) $,0&+3$() +()*&')$:() *$+$ $)(g,+$+ ), -,*33('0&.

L$ :3&-&*$03:33$ () ,' /$-0&+ 3*&+0$'0( (' -,$;,3(+ DMSU ;,( 3+(-0$& 3'3+(-0$('0( ('0+$ (' -&'0$-0& -&' ( -,(+*&. E0(')$) *+,(:$)+($3%$$) *&+ ( /$:+3-$'0( -&' :$)( (' -+30(+3&) 3'0(+'$-3&'$('0(()0$:(-3&) (0(+3'$' ,' '34( $-(*0$:( ( :3&-&*$03:33$. E' -$)&( +(,)&, ( +(*+&-()& *,(( -$:3$+ $ '$0,+$(%$ /)3-$, ;,3-$ &:3&g3-$ ( &) $0(+3$() ,033%$&) (' ( 3)*&)3034& +(),0$'& ('*+&:($) ( :3&-&*$03:33$. L$) *+,(:$) +(;,(+3$) *$+$ $)(g,+$+ ()0(-+30(+3& 4$' á) $á ( &) (3&) -&' ;,( -,('0$ $ 3')030,-3' ;,( +($3%$

( +(*+&-()&.

E /$:+3-$'0( )((--3&'$ -&'0+&$ &) $0(+3$() *$+$ $)(g,+$+ ()0$+ 3:+(( *3+g('&) ;,3-&). T*3-$('0( ( /$:+3-$'0( 0$:39' $-( *+,(:$) $3)*&)3034& )&:+( :$)() +(g,$+() *$+$ -&'/3+$+ ,' '34( $-(*0$:( ($,)('-3$ ( ('&0&3'$) :$-0(+3$() ;,( *&+$' $:(+ )3& 3'0+&,-3$),+$'0( ( *+&-()& ( /$:+3-$-3' (' $:3('0() -&'0+&$&). L&)+(*+&-()$&+() ( DMSU '&+$('0( '& ()0á' (' $ *&)3-3' *$+$$)(g,+$+ -&'/3+$+ $*3+&g('3-3$. P&+ & 0$'0& '& )&+*+('( ;,(

+($--3&'() *3+&g9'3-$) $$' )3& /+(-,('0(('0( -30$$) (' $ 30(+$0,+$-&& *+&,-0& ( +(,)& ( DMSU (:3& $ $ *+()('-3$ ( ('&0&3'$):$-0(+3$'$). L&) /$:+3-$'0() )((--3&'$' -&'0+&$' &) $0(+3$() 90&&) ( /$:+3-$-3' *$+$ $)(g,+$+ ;,( )( $-$'%$ ,'$ )(g,+3$:3&g3-$ $*+&*3$$. L&) 3)*&)3034&) 93-&) /+(-,('0(('0( )&' ),(0&)$ (0(')$) *+,(:$) *$+$ $)(g,+$+ ;,( ()0á' 3:+() ( 0&3-3$. E' -$)& (+(,)&, +()3,&) :3&g3-&) ;,3-&) ( &) *+&-()&) ( 3*3(%$ $4$&& ( *+&-()& ( ()0(+33%$-3', *,((' *(+$'(-(+ .

L&) 3)*&)3034&) ( ,' )&& ,)& ),) (*$;,() )&' )&(03&) $',(+&)$) *+,(:$) ( -&*$03:33$ -&' ( 90&& ( ()0(+33%$-3'()-&g3& *&+ ( /$:+3-$'0(. A,' $ +(*(03-3' ( 3)& 90&& (



()0(+33%$-3', *&+$ $/(-0$+ $4(+)$('0( $) -$+$-0(+)03-$) /)3-$) (-á'3-$) ( 3)*&)3034&.

L&) *+&-(33('0&) ,033%$&) *$+$ ( +(*+&-()$3('0& *,((' '& )(+

(/(-034&) *$+$ +(03+$+ +()3,&) -'3-&) ;,3-&) $'$03-&) , &0+&) ( &)3)*&)3034&) 93-&) *$+03-,$+('0( -,$'& ()0á' (' *$+0() 3'$--()3:()( 3)*&)3034&. E)0&) *+&-(33('0&) ( +(*+&-()& 0$:39' *&+$' /$$+ (' 3'$-034$+ ()0&) +()3,&). P&+ & 0$'0& $ ,' +3()g& ( 3'/(--3' -+,%$$& +(3'/(--3' -,$'& )( +(,)$' DMSU.

5.1.2 PROBLEMAS TECNICOS UE PUEDEN PRESENTARSECON EL REPROCESO

I'$:33$ *$+$ $-$'%$+ g$+$'03%$+ ,'$ 3*3(%$ (/(-034$.

F$0$ ( -&'&-33('0& (' -,$'0& $ $ -&*$03:33$ ( DMSU -&' (*+&-()& ( 3*3(%$, ()3'/(--3' & ()0(+33%$-3' )((--3&'$&.

A:)&+-3' ( &) $g('0() ,033%$&) ,+$'0( ( *+&-()& & $g('0()()0(+33%$'0() *&+ ( 3)*&)3034&, ;,( *,(( )(+ 0+$')/(+3& $ *$-3('0(,+$'0( ( ,)& & *,(( +($--3&'$+ -&' *+&,-0&) (3-3'$()

$3'3)0+$&).

A,)('-3$ ( *+&g+$$) ( $)(g,+$3('0& ( $ -$3$ *$+$ -&'/3+$+ ;,( &) 3)*&)3034&) +(*+&-()$&) '& )( $' (0(+3&+$& ,+$'0( (+(*+&-()&. E.H $0(+3$() *á)03-&) *,((' 4&4(+)( ;,(:+$3%&) *(+(+ /(3:33$ & /,(+%$ (-á'3-$ (-&&+$+)( & $g+3(0$+)(. L$-&')(-,('-3$ ( ()0&) -$:3&) (*('( ( 3)*&)3034& *(+& ,'((*& ( ()0( (0(+3&+& *,(( )(+ *(+3$ ( $) *+&*3($()$3)$'0() (9-0+3-$) (' $) g,$) 3$09+3-$.

I'$:33$ *$+$ $)(g,+$+ ;,( )( -,*(' $) ()*(-3/3-$-3&'()

T9-'3-$) ( ()(*(& ()0$:(-3$) *&+ ( /$:+3-$'0(. E.H *$+$ (:$' ( ,' -$090(+ $'0('33('0& ( (0(+3'$$ *+()3' *&+ ,'*(+3&& ()*(-3/3-& ( 03(*&, '& /,g$) ()0$3&).



6.@ REGLAMENTACIÓN VIGENTE

6.1 DECRETO "7252@@5

E)0( (-+(0& 03('( *&+ &:(0& +(g,$+ ( +9g3(' ( +(g3)0+&) )$'30$+3&)*(+3)& ( -&(+-3$3%$-3' 43g3$'-3$ )$'30$+3$ (' & +($-3&'$& -&' $*+&,--3' *+&-()$3('0& ('4$)( (*$;,( $$-('$3('0& (*('3&,)&, 3*&+0$-3', (*&+0$-3', -&(+-3$3%$-3' $'0('33('0& ( &)3)*&)3034&) 93-&) *$+$ ,)& ,$'& &) -,$() )(+á' ( &:3g$0&+3&-,*33('0& *&+ *$+0( ( 0&$) $) *(+)&'$) '$0,+$() & ,+3-$) ;,( )(

(3;,(' $ 3-$) $-0343$() (' ( 0(++30&+3& '$-3&'$.=>

D(0(+3'$ ;,( $ 43g3$'-3$ 93-$ ( &) 3)*&)3034&) 93-&) )( (:(+($3%$+H

F$)( ( *+(5$+-$1& *$+$ ), -&(+-3$3%$-3'.

F$)( ( $,0&+3%$-38' *$+$ ), -&5(+ -3$23%$-38'.

F$)( ( *&)05(+-$1& '& )($ ,+$'0( ( ,)& ( ()0&) 3)*&)3034&) & ;,(

$-( '(-()$+3& ;,( $ (4$,$-3', ( $ )(g,+3$ ( ()(*(& ), -$3$( -&'/(--3' ( $'(+$ -&'03',$.

E)0$ (4$,$-3' *(+303+á 3('03/3-$+ &) 3'-3('0() $4(+)&) & +3()g&) (3'-3('0() $4(+)&) ;,( *,3(+$' &-,++3+ ,+$'0( ), ,)&.

6.1.2 DISPOSITIVOS MEDICOS PARA USO #UM ANO

C,$;,3(+ 3')0+,('0& $*$+$0&, & $;,3'$. S&/0$+(, (;,3*& :3&93-& , &0+&$+03-,& )33$+ & +($-3&'$&, ,033%$& )&& & (' -&:3'$-3' 3'-,('& ),)-&*&'('0() *$+0() , $--()&+3&) *+&g+$$) 3'/&+á03-&) ;,( 3'0(+4('g$'(' ), -&++(-0$ $*3-$-3' *+&*,()0$ *&+ ( /$:+3-$'0( *$+$ ), ,)& (' H

D3$g')03-& *+(4('-3', ),*(+43)3', 0+$0$3('0& , $343& ( ,'$('/(+($.

3$g')03-&, *+&&-3', ),*(+43)3', 0+$0$3('0&, $343& & -&*&)3-3' (,'$ ()3' & ( ,'$ (/3-3('-3$.



I'4()03g$-3', ),)030,-3' &3/3-$-3', & )&*&+0( ( $ ()0+,-0,+$ $'$03-$& ( ,' *+&-()& /3)3&g3-&.

D3$g')03-& ( (:$+$%& -&'0+& ( $ -&'-(*-3'.C$,-3$ ,+$'0( ( (:$+$%& ( '$-33('0& & ()*,9) ( 3)&3'-,('& ( -,3$& ( +(-39' '$-3&.

P+&,-0& *$+$ ()3'/(--3' & ()0(+33%$-3' ( 3)*&)3034&) 93-&) &)3)*&)3034&) 93-&) *$+$ ,)& ,$'&, '& (:(+á' ((+-(+ $ $--3' *+3'-3*$;,( )( ()($ *&+ (3& /$+$-&g3-&, & (0$:3-&.

6.1.. CLASIFICACIÓN DEL DISPOSITIVO MDICO SEGN ELRIESGO

-C$)( I H B$& R3()g& H S&' $;,(&) 3)*&)3034&) 93-&) ( :$& +3()g&),(0&) $ -&'0+&() g('(+$() '& ()03'$&) *$+$ *+&0(g(+ & $'0('(+ $ 43$& *$+$ ,' ,)& ( 3*&+0$'-3$, ()*(-3$ (' $ *+(4('-3' ( (0(+3&+& ( $)$, ,$'$ ;,( '& +(*+()('0$' ,' +3()g& *&0('-3$

-C$)( II$ R3()g& M&(+$& S&' &) 3)*&)3034&) 93-&) ),(0&) $-&'0+&() ()*(-3$() (' $ /$)( ( /$:+3-$-3' *$+$ (&)0+$+ ), )(g,+3$ (/(-0343$.

-C$)( II: A0& R3()g&H S&' &) 3)*&)3034&) 93-&) ),(0&) $ -&'0+&()()*(-3$() (' ( 3)(& /$:+3-$-3' *$+$ (&)0+$+ ), )(g,+3$ (/(-0343$.

-C$)( III M, $0& R3()g&H S&' &) 3)*&)3034&) 93-&) ),(0& $-&'0+&() ()*(-3$() ()03'$&) $ *+&0(g(+ & $ $'0('(+ $ 43$ & *$+$ ,',)& ( 3*&+0$'-3$ ),)0$'-3$ (' $ *+(4('-3' ( (0(+3&+& ( $ )$,,$'&, & )3 ), ,)& *+()('0$ ,' +3()g& *&0('-3$ ( ('/(+($ & ()3'.



19

6.1." CRITERIOS DE CL ASIFIC ACIÓN

L$ $*3-$-3' ( $) +(g$) ( -$)3/3-$-3' )( +(g3+á *&+ $ /3'$3$ *+(43)0$ (&) 3)*&)3034&) 93-&)H

$> S3 ,' 3)*&)3034& 93-& )( ()03'$ $ ,033%$+)( (' -&:3'$-3' -&' &0+&3)*&)3034& 93-&, $) +(g$) ( -$)3/3-$-3' )( $*3-$+á' $ -$$ ,'& ( &)*+&,-0&) *&+ )(*$+$& ( *+&,-0& -&' ( ;,( )( ,033-('.

:> L&) )&*&+0() 3'/&+á03-&) ;,( )3+4$' *$+$ $'($+ ,' *+&,-0& & ;,( 0('g$'3'/,('-3$ (' ), ,033%$-3' )( 3'-,3+á' $,0&á03-$('0( (' $ 3)$ -$0(g&+$.

-> S3 ,' 3)*&)3034& 93-& '& )( ()03'$ $ ,033%$+)( (-,)34$ & *+3'-3*$('0((' ,'$ *$+0( ()*(-/3-$ ( -,(+*&, )( -&')3(+$+á *$+$ $ -$)3/3-$-3', ),,033%$-3' ()*(-/3-$ á) -+03-$.

> S3 *$+$ ( 3)& 3)*&)3034& 93-&, )&' $*3-$:() 4$+3$) +(g$) 0('3('& ('-,('0$ $) /,'-3&'() ;,( ( $0+3:,( ( /$:+3-$'0(, )( $*3-$+á' $) +(g$) ;,(-&',%-$' $ $ -$)3/3-$-3' á) ((4$$.

REGLAS DE CLASIFIC ACIÓN

P$+$ -$)3/3-$+ ,' 3)*&)3034& 93-& )( 0('+$' (' -,('0$ $) )3g,3('0()+(g$)H

A- D3)*&)3034&) 93-&) '& 3'4$)34&).

B- D3)*&)3034&) 93-&) 3'4$)34&).

C R(g$) $3-3&'$() $*3-$:() $ &) 3)*&)3034&) 93-&) $-034&).

D R(g$) ()*(-3$().

6.1.5 EUIPO BIOMEDICO

A*3-$ $ $;,(&) (;,3*&) ;,( '& $' )3& ,)$&) ;,( '& 0('g$' á) ( &)=2> $&) ()( $ /(-$ ( ), /$:+3-$-3'.

D( $-,(+& -&' ), -$)3/3-$-3' ( $0& +3()g& ( g+$& ( 4,'(+$:33$$)&-3$&) $ 3)*&)3034&) $) -&& &) (+34$&) ( 3)(&), /$:+3-$-3'3')0$$-3', $'(& ()03'& *+(43)0&.



L&) *+&0&03*&) ;,( -&'(4$' $ ',(4&) ()$++&&) -3('0/3-&) 0(-'&g3-&).

P$+$ ), $;,3)3-3' 3')0$$-3' ,033%$-3' +(;,3(+(' ,'$ 3'4(+)3' ),*(+3&+

$ &) 7@0 )$$+3&) '3&) (g$() 43g('0(). C$)3/3-$&) II: III -&'/&+( $& ()0$:(-3& (' ( *+()('0( (-+(0& )( ('-,('0+$' :$& &) *$+á(0+&) ($+03-,& 65 ( $ ( 715 ( 20@1.

PARAMETROS DEL ARTCULO 65 DE LA LE? 715 DE 2001

P$'() :3('$() ( 3'4(+)3&'() (' )$2,1.

L$) )(-+(0$+$) ( )$, (*$+0$('0$() 3)0+30$() *+(*$+$+á' -$$ &)$&) ,' *$' :3('$ ( 3'4(+)3&'() *<:3-$) *+34$$) (' )$,, (' ( -,$ )(3'-,3+á' $) ()03'$$) $ 3'/+$()0+,-0,+$, &0$-3' & (;,3*&) :3&93-&) ;,( (M3'3)0(+3& ( S$, (0(+3'( ;,( )($' ( -&'0+& ()*(-3$.

E)0&) *$'() )( 3'3-3$+á' -&' $ ($:&+$-3' ( ,' 3'4('0$+3& -&*(0& )&:+( $&/(+0$ (3)0('0( (' $ +()*(-034$ +(, (:(+á' *+()('0$+)( $ &) C&')(&)T(++30&+3$() ( S(g,+3$ S&-3$ (' S$,.

L&) P$'() :3('$() (:(+á' -&'0$+ -&' $ $*+&:$-3' ( M3'3)0(+3& ( S$,*$+$ ;,( )( *,($ 3'3-3$+ -,$;,3(+ &:+$ & *+&-()& ( $;,3)3-3' ( :3('() &)(+43-3&) -&'0(*$& (' (&).

N& *&+á' +($3%$+)( 3'4(+)3&'() (' 3'/+$()0+,-0,+$, &0$-3' & (;,3*&) ;,( '&)( ('-,('0+(' (' ( *$' :3('$ ( 3'4(+)3&'() (' )$,. S3' *(+,3-3& ( $))$'-3&'() $3'3)0+$034$) $ ;,( ,:3(+( ,g$+ . L$ 3')030,-3' *<:3-$ ;,( +($3-(3'4(+)3&'() *&+ /,(+$ ( *$' :3('$, '& *&+á /3'$'-3$+ -&' +(-,+)&) (S3)0($ G('(+$ ( P$+03-3*$-3&'() ( -&)0& ( $ 3'4(+)3' & ( ( &*(+$-3'

/,'-3&'$3('0& ( &) ',(4&) )(+43-3&). C,$'& $) 3')030,-3&'() *+34$$)+($3-(' 3'4(+)3&'() *&+ /,(+$ ( *$' :3('$, '& *&+á' )(+ -&'0+$0$$) -&'+(-,+)&) ( S3)0($ G('(+$ ( S(g,+3$ S&-3$ (' S$,.

E *$' :3('$ ( 3'4(+)3&'() (/3'3+á $ 3'/+$()0+,-0,+$ (;,3*&) '(-()$+3&) ('$) á+($) ;,( ( M3'3)0(+3& ( S$, (/3'$ -&& ( -&'0+& ( &/(+0$. L$)3')030,-3&'() *<:3-$) & *+34$$) ;,( +($3-(' 3'4(+)3&'() (' ()0$) á+($) '&*+(43)0$) (' ( *$' :3('$ )(+á' )$'-3&'$$). L&) g(+('0() $) ,'0$)3+(-034$) ( $) 3')030,-3&'() *<:3-$) *&+á' )(+ ()030,3&) *&+ $$-&',-0$ $) 3')030,-3&'() *+34$$) '& *&+á' )(+ -&'0+$0$$) -&' +(-,+)&)

( S3)0($ G('(+$ ( S(g,+3$ S&-3$ (' S$,.



6.1.6 EUIPO BIOMEDICO REPOTENCI ADO

S&' &) (;,3*&) ;,( $' )3& ,033%$&) (' $ *+()0$-3' ( )(+43-3&) & ('*+&-()&) ( (&)0+$-3' (' &) -,$() *$+0( ( ), ),:)3)0($ *+3'-3*$ $)3& ),)030,3& -&' *3(%$) ',(4$) *&+ ( /$:+3-$'0( & ( +(*&0('-3$&+ $,0&+3%$&. ;,( -,*$' -&' &) +(;,3)30&) ()*(-3$() *&+ ( /$:+3-$'0( $)'&+$) ( )(g,+3$ :$& $) -,$() /,(+&' -&')0+,3&).=>

6.1.7 REPOTENCI AMIENTO

S&' 0&&) &) (;,3*&) 93-&) ,)$&), +($-&'3-3&'$&) ( $-,(+& -&' $)()*(-3/3-$-3&'() &+3g3'$() ( /$:+3-$'0(.

E)0( *+&-()& (:(+á -,*3+ -&' $) '&+$) ( :3&)(g,+3$ &) +(;,3)30&);,( ()*(-3/3;,( ( /$:+3-$'0(.

L$ ),:)030,-3' ( &) )3)0($) *+3'-3*$() ( (;,3*& :3&93-&+(*&0('-3$& )&& )(+á *&)3:( $-(+)( -&' ((('0&) *$+0(), *3(%$) +(*,()0&) ',(4&) +(*&0('-3$&) *&+ ( 3)& /$:+3-$'0(.

6.1.8 REUISITOS PARA LA AUTORIACIÓN DEIMPORTACIÓN, EUIPO BIOMEDICO REPOTENCI ADO.

S( *&+á $,0&+3%$+ $ 3*&+0$-3' ( (;,3*& :3&93-& &) -,$() )(+á'-&')3(+$&) -&& ( 0(-'&&g$ -&'0+&$$ *$+$ (& )( +(;,3(+( ( H

,( ( (;,3*& :3&93-& +(*&0('-3$& -,('0( -&' $) 3)$)-$+$-0(+)03-$) ( (/(-0343$, )(g,+3$ ()(*(& ( (;,3*& :3&93-&',(4&.

,( ( (;,3*& :3&93-& +(*&0('-3$& -,('0( -&' $ &-,('0$-3' $ $ ;,($-( +(/(+('-3$ ( (-+(0& "725 ( 2005 *$+$ $ 3*&+0$-3' ( (;,3*&),)$&) () (-3+ ;,( '& 0('g$' $) ( -3'-& $&) ( /$:+3-$-3'.

,( ( 030,$+ ( +(g3)0+& )$'30$+3& & *(+3)& ( -&(+-3$3%$-3' ( (;,3*&+(*&0('-3$& -,('0( -&' ( +(g3)0+& )$'30$+3& & ( *(+3)& (-&(+-3$3%$-3' ( ,' (;,3*& :3&93-& ',(4& ( 3g,$() -$+$-0(+)03-$).



,( ( 3*&+0$&+ -,('0( -&' $ $,0&+3%$-3' ( /$:+3-$'0( & ),+(*+()('0$'0( (' ( *$) *$+$ 3*&+0$+ ),) (;,3*&) ;,( $' )3&+(*&0('-3$&).

L&) (;,3*&) :3&93-&) ;,( (30(' +$3$-3&'() 3&'3%$'0() (:(+á' -&'0$+ -&' ,'$ $,0&+3%$-3' (303$ *&+ $ $,0&+3$ -&*(0('0( (' $ $0(+3$ *$+$( $'(& ( ()0$ -$)( ( (;,3*&).

6.2 DECRETO "562 DE 20@6

E*(3& (' $ -3,$ ( B&g&0á DC *,:3-$& ( 26 ( D3-3(:+( (

2@06.

P&+ ( -,$ )( $3-3&'$ ,' *$+ág+$/& $ $+03-,& 86 ( (-+(0& "725 ( 20@5.

P$+$ &) 3)*&)3034&) 93-&).

-C$090(+() )&'$) ),0,+$) $0(+3$() ( -,+$-3', g$)$) $g&&'() 4('$) ('()$$) ()*$+$*&) $*&)30&) $g,$) 3*&9+3-$) *+()(+4$034&)$+-$*$)&) 4á4,$) -$+3$-$) 4á4,$) *$+$ 3+&-(/$3$. =>

- P+&,-0&) O&'0&g3-&). C(('0&) -&*,()0&) ( &($&, )33-&'$)$g3'$0&) 3+&-&&3() +(4(+)3:( ( 3++(4(+)3:(, $0(+3$() *$+$ +()0$,+$-3' &:0,+$-3' ( -&',-0&) +$3-,$+(), )( ('-,('0+(' $*$+$&) & '& -&'+(g3)0+&, *$+$ ), -&(+-3$3%$-3' (:(+á' &:0('(+ +(g3)0+& )$'30$+3&, (' $)-&'3-3&'() ()0$:(-3$) (' ( *+()('0( (-+(0& $ á) 0$+$+ ( 1 ( $:+3 (2@07Q.

ARTICULO 86 DEL DECRETO "725 DE 2005

P$%&). T+$)-,++3&) &) =2> $&) $ *$+03+ ( $ 43g('-3$ ( *+()('0( (-+(0&$ *+&,--3' & 3*&+0$-3' ( 3)*&)3034&) 93-&) & (;,3*&) :3&93-&) (0(-'&&g$ -&'0+&$$ (:(+á' -&'0$+ -&' &) -&++()*&'3('0() +(g3)0+&))$'30$+3&) & *(+3)&) ( -&(+-3$3%$-3' ( $-,(+& -&' & ()0$:(-3& (' (*+()('0( (-+(0&.

L&) (;,3*&) :3&93-&) ( 0(-'&&g$ -&'0+&$$ ;,( )( 3*&+0(' & /$:+3;,(',+$'0( ()0( *$%& ;,( '& $$' &:0('3& ), $,0&+3%$-3' ( 3*&+0$-3'(:(+á' )(g,3+ )&3-30$'& $ $,0&+3%$-3' +()*(-034$ )(g<' $) 3)*&)3-3&'()43g('0().

L&) $:&+$0&+3&) ()0$:(-33('0&) /$:+3-$'0() ( 3*&+0$&+() ( 3)*&)3034&)93-&) (;,3*&) :3&93-&) ( 0(-'&&g$ -&'0+&$$ ;,( )( ('-,('0+('$-0,$('0( $*$+$&) :$& +(g3)0+& )$'30$+3&, 3)*&'+á' ( 3)& *$%&,



*$+$ $(-,$+ $) (03;,(0$) (*$;,() ( $-,(+& -&' & *+(43)0& (' (*+()('0( (-+(0& (' $ +(g$('0$-3' ;,( )( (*3$ )&:+( ( *$+03-,$+

6. BUEN AS PR ACTIC AS DE M ANOF ACTUR A ?CERTIFIC ADOS DE ALM ACEN AMIENTO ?

ACONDICIONAMIENTO DE LOS DISPOSITIVOS MEDICOS

B,('$) *+á-03-$) ( $',/$-0,+$ ( 3)*&)3034&) 93-&)

E*(3-3' ( -(+03/3-$& ( :,('$) *+á-03-$) ( $',/$-0,+$. L(-&++()*&'( $ 3')030,0& '$-3&'$ ( (3-$('0&) $3('0&) INVIMA.

C(+03/3-$& ( C$*$-3$ ( A$-('$3('0& A-&'3-3&'$3('0& ( &)D3)*&)3034&) M93-&) CCAA, ()0$:(-3$) *&+ ( 3'3)0(+3& ( $ *+&0(--3')&-3$.

E*(3-3' ( C(+03/3-$& ( C$*$-3$ ( A$-('$3('0& A-&'3-3&'$3('0&, -&++()*&'( (*(3+& $ INVIMA.

6." INSTITUCIONES INVOLUCRADAS EN EL CONTROL ?VIGILANCIA DE LOS DISPOSITIVOS MEDICOS.

S&' -,(+*&) '&+$034&) -&'/&+$&) *&+ ,' -&','0& ( 3($), -+(('-3$)4$&+() +(g$) ;,( -&'3-3&'$' $) /&+$) ( 3'0(+-$:3& )&-3$, ('0+( ($)('-&'0+$&)H

- MINISTERIO DE LA PROTECCIÓN SOCIALH E) *&+ (-(('-3$ ,' ('0(+(g,$&+ ;,( )( ('-$+g$ ( /3$+ '&+$) 3+(-0+3-() (' $0(+3$ (*+&0(--3' )&-3$.T3('( -&& &:(034&) *+3&+3$() $ /&+,$-3' $&*-3' 3+(--3'-&&+3'$-3', ((-,-3', -&'0+& )(g,33('0& ( )3)0($ ( $ *+&0(--3')&-3$.

INVIMAH E) ,'$ 3')030,-3' ( 43g3$'-3$ -&'0+& ( -$+á-0(+ 09-'3-&-3('0/3-&, ;,( 0+$:$$ *$+$ $ *+&0(--3' ( $ )$, 3'343,$ -&(-034$ (&) -&&:3$'&) (3$'0( $ $*3-$-3' ( $) '&+$) )$'30$+3$) +($-3&'$$)

-&' &) *+&,-0&) ( ), -&*(0('-3$.

- SUPERSALUDH () ,' ('0( /3)-$3%$&+ ( &) )(+43-3&) ( )$, (' ( *$).



7.0 RESOLUCIÓN 1@" DE 2@@6

*,:3-$$ ( ( $:+3 ( 2006 (' $ -3,$ ( B&g&0á DC, *&+ $ -,$ )( ()0$:(-(' $) -&'3-3&'() ;,( (:(' -,*3+ &) *+()0$&+()( )(+43-3&) ( )$, *$+$ $:330$+ ),) )(+43-3&) ( 3*(('0$+ ( -&*&'('0(( $,30&+3$ *$+$ ( (&+$3('0& ( $ -$3$ ( $ $0('-3'.=>

L&) *+()0$&+() ( )(+43-3&) ( )$, 0&&) $;,(&) ()0$:(-33('0&) ;,(*+()0(' )(+43-3&) ( )$,, )($ ()0( & '& ,' &:(0& )&-3$, (:(+á' -,*3+ *$+$ ), ('0+$$ *(+$'('-3$ (' ( )3)0($ <'3-& ( $:330$-3' -&' &))3g,3('0(H

$- D( -$*$-3$ 0(-'&28g3-$ -3('0/3-$H )&' &) ()0á'$+() :á)3-&) (()0+,-0,+$ ( *+&-()&) ;,( (:(' -,*3+ &) *+()0$&+() ( )(+43-3&) ()$, *&+ -$$ ,'& ( &) )(+43-3&) ;,( *+()0(' '(-()$+3&) *$+$ +(,-3+ &)*+3'-3*$() +3()g&) ;,( $('$%$ $ 43$ & $ )$, ( &) ,),$+3&).

: S,/3-3('-3$ *$0+35&'3$2 /3'$'-3(+$H E) ( -,*33('0& ( $)-&'3-3&'() ;,( *&)3:330$' $ ()0$:33$ /3'$'-3(+$ ( $) 3')030,-3&'()*+()0$&+$) ( )(+43-3&) ( )$,.

-- D( -$*$-3$ 09-'3-& $153'3)0+ $034$.

7.1 ESTANDAR N& " MEDICAMENTOS ? DISPOSITIVOSMEDICOS

A*3-$ *$+$ 0&&) &) )(+43-3&)

7.1.2 CRITERIOSH L$ 3')030,-3' 03('( ,' 3)0$& ;,( 3'-,( 0&&) &)

(3-$('0&) *$+$ ,)& ,$'& +(;,(+3&) *$+$ $ *+()0$-3' ( &) )(+43-3&);,( &/+(-( 3-& 3)0$& (:( 3'-,3+ ( *+3'-3*3& $-034&, /&+$ /$+$-9,03-$-&'-('0+$-3', &0( +(g3)0+& )$'30$+3&, /(-$ ( 4('-33('0& *+()('0$-3'-&(+-3$, )(g<' & ()0$:(-3& (' ( (-+(0& 22@0 ( 2005 & $) (á)'&+$) ;,( & &3/3;,(', $3-3&'(' & ),)030,$'. *$+$ 3)*&)3034&) 93-&) ,'3)0$& ;,( 3'-,$ '&:+( g('9+3-& & $+-$ ( 3)*&)3034&, *+()('0$-3'-&(+-3$, +(g3)0+& )$'30$+3& 43$ <03 )3 $*3-$ -$)3/3-$-3' ( $-,(+& $+3()g&, )(g<' & ()0$:(-3& (' ( (-+(0& "725 ( 2005 & (á) '&+$) ;,(& $3-3&'(' &3/3;,(' & ),)030,$'.

S( 03('(' (/3'3$) $) ()*(-3/3-$-3&'() 09-'3-$) *$+$ $ $;,3)3-3' )($*3-$' *+&-(33('0&) 09-'3-&) *$+$ $$-('$3('0& 3)0+3:,-3' (



(3-$('0&) *+&,-0&) :3&g3-&) +($-034&) 3)*&)3034&) 93-&) 3'-,3&)&) ( ,)& &&'0&g3-&.

L&) *+&-(33('0&) ( $;,3)3-3' ( (3-$('0&) 3)*&)3034&) 93-&)3'-,(' $ 4(+3/3-$-3' ( +(g3)0+& (*(3& *&+ ( INVIMA ( *+&g+$$ (/$+$-&43g33$'-3$ 0(-'&43g3$'-3$.

S( 03('(' (/3'3$) '&+$) 3')030,-3&'$() *+&-(33('0&) *$+$ ( -&'0+& (), -,*33('0&, ;,( g$+$'03-(' ;,( '& )( + ( , )( ' 3)*&)3034&) 93-&). E'0$'0& )( (/3'$' $ +($-3' -&'3-3&'() ( +(,)& ( 3)*&)3034&) 93-&) &)*+()0$&+() *&+á' +(,)$+ )3(*+( -,$'& (/3'$' ((-,0('*+&-(33('0& :$)$&) (' (43('-3$ -3('0/3-$ ;,( (,()0+(' ;,( '&3*3-$' +(,--3' ( $ (/3-$-3$ *$+$ $ -,$ )( ,033%$ ( 3)*&)3034& (3-& '3

+3()g&) ( 3'/(--3&'() & -&*3-$-3&'() *&+ &) *+&-(33('0&) *$+$ (,),$+3&, -&' )(g,33('0&) $ 0+$49) ( -&309 ( 3'/(--3&'().

P$+$ ( -,*33('0& ( &) -&309) ( 3'/(--3&'() )( -+(& $+()&,-3' @6 ( 1!!!, *,:3-$$ ( 0 ( 3-3(:+( ( 3)&$& (' $ -3,$ ( B&g&0á DC.

L$ +()&,-3' $-( +(/(+('-3$ $ ;,( () &:3g$-3' ( &)*30$D('0+& ( *$' ( &+g$'3%$-3' g('(+$, -&')3(+$+ ( -&'0+& ($) 3'/(--3&'() -&& -&*+&3)& ( *(+$'('0( +3g,+&)$$*3-$-3' $$) $) +(*(+-,)3&'() ;,( $ 3'/(--3' )3g'3/3-$()( ( *,'0& ( 43)0$ ( $ -$3$ ( )(+43-3& $ $*3$-3';,( 03('( ( *+&:($ (' $ (-&'&$ ( $ 3')030,-3'.

E -&309 ( 3'/(--3&'() -,*( -&' 34(+)$) /,'-3&'() 0$()-&& H

V($+ *&+ ( -,*33('0& ( $) '&+$) (3$) ( -&'0+& ()0$:(-3$).

A'$3%$+ 3/,'3+ &) +(),0$&) ( $ 43g3$'-3$ (*3(3&g3-$.

R($3%$+ 3'0(+4('-3' &*&+0,'$ -,$'& )( *+()('0( ,' -$)& ( :+&0(.

T+$:$$+ (' (;,3*& 3'0(+3)-3*3'$+3& *$+$ g$+$'03%$+ $ -$3$ ( $ $0('-3'*+()0$$ $ &) *$-3('0() 3)3',3+ &) +3()g&) ( 3'/(--3' $ /$33$+()43)30$'0() $ 0+$:$$&+() ( $ )$,.

R($3%$+ +(,'3&'() -$$ 2 ()( ( $'(+$ &+3'$+3$ (0+$&+3'$+3$.

I('03/3-$+ '(-()3$() 3')030,-3&'$() -&' ( /3' ( ()$++&$+ *+&g+$$) (-$*$-30$-3' $-0,$3%$-3' & 3*(('0$-3' ( ',(4$) 0(-'&&g$) g,$) *+&-(33('0&) (0-.



8.0 CLASIFICACIÓN DE DISPOSITIVOS MEDICOS SEGNCATEGORIA DE RIESGO S ANIT ARIOS

PRUDUCTOS ODONTOLOGICOS =">

P+&1,-0& O1&'0&28g3-& T3*& ( R3()g& Ag,$ *$+$ $'()0()3$ C$)( I Ag,$ (+3'g$ 3*&9+3-$ C$)( II Ag&' (' T&+,'$ C$)( IB$0$ *$+$ +(($3'$-3' C$)( IB&;,( *$+$ (430$+ &+3$ C$)( IE'4&0,+$ *$+$ ()0(+33%$-3' C$)( I

E)*&'$ ( g$)$ E)09+3 C$)( II A+03-,$& C$)( IG,$'0() C$)( IIM$'g&) *$+$ :3)0,+ C$)( I A:+$%$(+$ *+(/&+$$ C$)( I A:)&+:(&+ ( )$34$ C$)( I A-034$&+ U0+$43&(0$ *$+$ *&3(+3%$-3' C$)( I Ag,$ ('0$ ( 3'(--3' C$)( II A$g$$ (' -$*),$) C$)( II A'-$( C$)( I A*3-$&+ ( +()3'$ C$)( I A+-& /$-3$ C$)( IB$+'3% -$43$() C$)( IIC(('0& D('0$ C$)( IB$)( ( O3& ( %3'- E,g('& C$)( IIC(+/(+&) C$)( IIC&*&'(+&) C$)( IIC&*$ ( *+&/3$3) C$)( IC(*3& P+&/3á-03-& C$)( ID3;,( ( G&$ $--()&+3&) C$)( IE$3'$&+ P,*$+ C$)( I

F+()$ D('0$ C$)( IF,('0( ( -$&+ *$+$ :$';,($3('0& D('0$ C$)( IG( )&,-3&'() *$+$ :$';,($3('0& ('0$ C$)( IIG(() )&,-3&'() /('&$$) ( ,)& D&()03-& C$)( IIG(() )&,-3&'() /('&$$) ( ,)& *+&/()3&'$ C$)( I#3+3& ( -$-3& R(4()03&+ ( -$43$() C$)( II#3& R(0+$-0&+ C$)( II*$'0( ('&)(&) C$)( IIII')0+,('0$ P$+$ (&&'-3$ D('0$ C$)( II')0+,('0$ P$+$ ('&&'-3$ C$)( I=3$) ('0,&),T3+$'(+43&)> C$)( I

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M$0(+3$ ( +(4()033('0& *$+$ +()3'$) ( +(('& C$)( IIM(3&+ ( /,3& g3'g34$() C$)( IM(+-,+3& D('0$ C$)( IP$)0$ *+&/3á-03-$ ( ,)& P+&/()3&'$ C$)( IP3(%$ ( $'& C$)( IP&)0() *$+$ -$'$() +$3-,$+() C$)( IR()3'$ $()34$ *$+$ :+$-(0 C$)( IIR()3'$ ('0$ -&& $g('0( $()34& C$)( IIR()3'$ & -(('0& ( +(('& *$+$ -$'$() +$3-,$+() C$)( IIR()3'$ *$+$ -&+&'$) 0(*&+$() *+0()3) C$)( IIIS($&+ ( /&)(0$) /3),+$) C$)( II

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!.0 ESTRATEGIAS PARA EL CONTROL DE INFECCIONES ENODONTOLOG A

U'$ -+3)3) ( ('/(+($() 3'/(--3&)$) -&' *+&*&+-3&'() g&:$() $('$%$$) (&+$) $/$'&)$('0( &:0('3$) (' )$, (' (*(-0$034$) ( 43$. L$)('/(+($() 3'/(--3&)$) )&' $&+$ $ *+3'-3*$ -$,)$ ( &+0$3$ 3'/$'03 ( $,0&) 4('() -&' á) ( 0+(-( 3&'() ( ,(+0() $',$('0(.

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C&' ( &:(034& ( -&*$+03+ ()0$ 4$3&)$ 3'/&+$-3' -&' $ -&,'3$&&'0&g3-$. =5>

L$ 3)3' ( C('0+& ( A0('-3' $ P$-3('0() -&' E'/(+($()I'/(-0&-&'0$g3&)$) =CAPEIUCV>, () &g+$+ ,' 0+$0$3('0& &&'0&g3-& )(g,+& 3:+( ( 3'/(--3&'() *$+$ &) *$-3('0() ;,( $ $-,(' $ +(-3:3+ $0('-3' :,-&('0$, *)3-&g3-& ',0+3-3&'$. L$ (0$ () $,('0$+ (' /&+$ (),+$:( $3'/&+$-3' )&:+( -&'0+& ( 3'/(--3&'() (' :3&)(g,+3$ ('0+& ( $-&,'3$ &&'0&g3-$.



E) ,)0& ('-3&'$+ ;,( '& )( ,)03/3-$ $ '(-()3$ ( 0&$+ *+(-$,-3&'()$3-3&'$() )3 ( *(+)&'$ ( $ )$, )&)*(-$ ;,( ( *$-3('0( () *&+0$&+ (,'$ ('/(+($ 3'/(-0&-&'0$g3&)$. T&$) $) ()0+$0(g3$) *$+$ ( -&'0+& (3'/(--3&'() (' -&'),0&+3& &&'0&g3-& (:(' $-(+)( ( +,03'$, *,() ($)

()0á' ()0$:(-3$) *&+ ( *+&-(33('0& $ +($3%$+ '& *&+ $ ('/(+($ ;,(( *$-3('0( *+()('0$.

!.1 O:(034&) D( C&'0+&2 D( I'/(--3&'() E' O1&'0&2&g$

D( $-,(+& -&' &) &+g$'3)&) 3'0(+'$-3&'$() O+g$'3%$-3' ,'3$ ( $

S$, =OMS> O+g$'3%$-3' P$'$(+3-$'$ ( $ S$, =OPS> C('0+& (C&'0+& P+(4('-3' ( ('/(+($() ( &) E)0$&) U'3&) ( N&+0($9+3-$=CDC> A)&-3$-3' D('0$ A(+3-$'$ =ADA>. L&) O:(034&) )&' &) )3g,3('0()H

O/+(-(+ ,'$ *+á-03-$ )(g,+$ $ *$-3('0() 0+$:$$&+() ( $ )$,.

E430$+ $ 3)(3'$-3', ('-,:+33('0& *+()(+4$-3' ( ('/(+($()3'/(--3&)$) ('0+& ( -&'),0&+3& &&'0&g3-&.

D3)3',3+ &) +3()g&) ( -&'0$3'$-3' $--3('0() $:&+$().

C,*3+ -&' +(;,3)30&) 903-&) &+$() (g$() ( ((+-3-3& *+&/()3&'$ -&' (() +(g$('0&) '$-3&'$() ( 3'0(+'$-3&'$()

!.1.2 C&'13-3&'() F$4&+$:2() P$+$ T+$')53)38' D(E'/(+5(1$1() 3'/ (--3&)$)

L$ '$0,+$(%$ ( $ $&+$ ( &) *+&-(33('0&) ('0$() 3')0+,('0$-3' ('0&+'&) ( -,3$& ( *$-3('0(, +(;,3(+(' ( ()0+$0(g3$) ()*(-3/3-$) *$+$ (-&'0+& ( 3'/(--3&'(). S3' (:$+g& *$+$ ;,( )( 0+$')30$ ,'$ 3'/(--3' )&''(-()$+3$) 0+() -&'3-3&'()H

1- P(+)&'$ ),)-(*03:( $ $ 3'/(--3'.

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- U'$ *,(+0$ *$+$ ;,( ( 3-+&&+g$'3)& *('(0+( $ *(+)&'$.



29

E' &) *+&-(33('0&) ('0$() $ 0+$')3)3' ( $ 3'/(--3' 4$ $ (*('(+ (-,$0+& /$-0&+()H

1- F,('0( ( 3'/(--3' =*$-3('0(&*(+$&+>.

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1@. INSTRUCTIVO PARA EL REGISTRO DE DISPOSITIVOSMEDICOS ODONTOLOGICOS, O MATERIALES ? EUIPOS.

1- DATOS DEL PRODUCTO =6>

A- N&:+( (D3)*&)3034&---------------------------------------------------- B- N&:+(-&(+-3$----------------------------------------------------- CI'3-$-3&'() -&'3-3&'() ( ,)& ( *+&,-0&--------------------

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2- DATOS DEL F ABRIC ANTE

A -N&:+( -&*(0& ( /$:+3-$'0(------------------------------------ B -P$) (O+3g('----------------------------------------------------------- C-D3+(--3'------------------------------------------------------------------ D-T(9/&'&------------------------------------------------------------------

- E-F$------------------------------------------------------------------------

--

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- DATOS DEL PROFESIONAL RESPONS ABLE

A N&:+(-&*(0&--------------------------------------------------------- BD3+(--3' -&'),0&+3& & IPS-------------------------------------------

------------------------------------------------------------------------------

----- C T(9/&'&-------------------------------------------------------------------- DF$--------------------------------------------------------------------------

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--- FIRMA DEL PROFESIONALRESPONSABLE



40

INSTRUCTIVO DE REGISTRO

REUISITOS UE SE DEBERWN CUMPLIR PARA EL REGISTROSANITARIO DE LOS DISPOSITIVOS MDICOSH

S&23-30,1 (' F&+$0& ()0$:2(-31&H L('$+ ( /&+,$+3& =( )&3-30, &+3g3'$ -&*3$, /&3$&, 3:+( ( ('3('$) :&++&'() ( /&+$0& (:3$('0(('-,$(+'$& ( 3'3-$'& -&' )(*$+$&+() &) 3)03'0&) &-,('0&) $,'0&)>( R(g3)0+& S$'30$+3&, ( -,$ 3('03/3-$ ( *+&,-0&, ( 03*& ( )&3-30, =+(g3)0+&+(4$3$-3' $0(+$-3' -$'-($-3' &0+&) =3('03/3-$+> $-&*$$+ ( &)-&*3$) -&' &) $0&) ( 3'/&+$-3' *(+03'('0() ()0$:(-3&). E' ( 4$ ( 03*&( 3)*&)3034& 93-&, ( '&:+( 09-'3-& ( 3)*&)3034& 93-& ( '&:+(-&(+-3$ ( 3)*&)3034& 93-&, -$3/3-$-3' -&'/&+( -&' $) +(g$)()0$:(-3$) /3+$ ( +()*&')$:( (g$, /3+$ ( +()*&')$:( 09-'3-&.I'/&+$-3' ( /$:+3-$'0( 3*&+0$&+ =I('03/3-$-3' ( $ $-0343$ ( $(*+()$, -&++()*&'3('0( $ $ )&3-30, ( +(g3)0+& ( &) *+&,-0&) 93-&H/$:+3-$-3' & 3*&+0$-3'.

C(+03/3-$1& ( 3:+( 4('0$ ;,( (,()0+( ), ,)& (' ( *$) ( &+ 3g('HC(+03/3-$& ( 3:+( 4('0$, -,$'& ( *+&,-0& *+&-(( ( (0+$'(+&, (:(+á)(+ (*(3& *&+ $ $,0&+3$ -&*(0('0( ( *$) (*&+0$&+ , (:3$('0(

$,0('03-$&, ;,( ( *+&,-0& ()0( +(g3)0+$& (' ( *$) ( &+3g(' ;,( (/$:+3-$'0( -,*$ -&' $) :,('$) *+$-03-$) ( /$:+3-$-3' -$)3 )3(*+( 43('('-&' ( -(+03/3-$& ( 3:+( 4('0$ =CLV>, -(+03/3-$& ;,( )( $ $,0&+3%$& $ 4('0$( *+&,-0& *$+$ ,)& (' ( 0(++30&+3& '$-3&'$ 43('( ( 3g,$ /&+$ (' ( =CLV>;,( $ /á:+3-$ & $:&+$0&+3& ()0( )&(03& $ 3')*(--3&'() +(g,$+() (' ( *$)( &+3g(' 43('( (' ( =CLV>.

C(+03/3-$1& ( FDA CE, & TUVH Ag('-3$ ( '&+$) ISO =-(+03/3-$& (/$:+3-$-3' )(g<' )3)0($ ( -$3$= (' 3)(&, ()$++&& *+&,--3'> !@01*$+$ $) C$)() I, III IV, =-(+03/3-$& ( /$:+3-$-3' )(g<' )3)0($ ( -$3$H

(' $ *+&,--3', 3')0$$-3' )(+43-3&> !@@2 *$+$ $) C$)() I II, 1"85-200( $ 3',)0+3$ ( 3)*&)3034&) 93-&) &(& ( $)(g,+$3('0& ( -$3$ ('$ 3')*(--3' (')$&) /3'$() !00 $ !@@"-1 =() ( &(& ($)(g,+$3('0& ( $ -$3$ (' ( 3)(&, ()$++&&, *+&,--3', 3')0$$-3' )(+43-3& ( ,' 3)*&)3034& 93-&>.

E03;,(0$) +80,2&) (*$;,()H E03;,(0$, +0,& & (*$;,(, (*3-$-3' (), -&'0('3&, (:(+á' *+()('0$+ (' &) +0,&) & 3'/&+$-3&'() 3*+()$) ;,(& $-&*$$', $) )3g,3('0() ()*(-3/3-$-3&'() ()-+30$) (' 33&$ ( *$) (' (-,$ ()0á S3('& )&3-30$& ( +(g3)0+& ( & &) *+&,-0&). N&:+( ( *+&,-0&'&:+( ( /$:+3-$'0( ( *$) ( &+3g(', /(-$ ( /$:+3-$-3', '<(+& ( &0(& '<(+& ( )(+3( &(&, /(-$ ( 4('-33('0& =() $&> -,$'& $*3;,(-&'3-3' ( ()0(+33%$-3' $$-('$3('0& -,$'& $*3;,(, *+&*)30& ,)&



3'3-$& )3:&&g$ '&0$) ( $4(+0('-3$) 3')0+,--3&'() *$+$ ), ,)&'&+$) ()0á'$+() ( )(g,+3$ (9-0+3-$ *$+$ 3)*&)3034&) 93-&) UL &IEC *$+$ &) 3)*&)3034&) ;,3&) & g(() )( +(;,(+3+á ( ($(' $'$03-&)H*+,(:$) /)3-& ;,3-$) =P, 4&,(', (')3$ ()0$:33$>,

*+,(:$) &+g$'&9*03-$) =&&+ , -&&+ , 0(0,+$>, *+,(:$ 3-+&:3&g3-$, *(3+ $/$:+3-$'0( ()*(-3/3-$-3&'() ( *+&,-0& 0(+3'$&, 0('+á ;,( *+&*&+-3&'$+ ,()0+$) ),/3-3('0( *$+$ ), $'á3)3) -,$'& $*3;,(.

L3:+& ( -$0á&g& $-0,$23%$1& &'( )( ('-,('0+$ ( *+&1,-0&H L3:+& (-$0$&g& $-0,$3%$& &'( )( ('-,('0+$ ( *+&,-0&, ()-+3*-3&'() (0$$$)( *+&,-0&, 3'-,('& &) /,'$('0&) ( ), /,'-3&'$3('0& ( ), $--3'), -&*&)3-3' -,$'& )($ $*3-$:(, 3'3-$-3' /3'$3$ ,)& $ ;,( )(()03'$ ( *+&,-0& 93-& ), *+3'-3*3&) -&'0('3&, *+(-$,-3&'()+()0+3--3&'() $4(+0('-3$) /&+$ ( *+()('0$-3' ( *+&,-0&.

C(+03/3-$1& ( B,('$) P+á-03-$) ( M$',/$-0,+$H C(+03/3-$& ( :,('$)*+á-03-$) ( $',/$-0,+$, -&','0& ( '&+$) *+&-(33('0& ()03'$$) $g$+$'03%$+ $ *+&,--3' ,'3/&+( ( &0() 3)*&)3034&) 93-&) $) -&& ),)(g,+3$ (/3-$-3$, )(g<' ()0á'$+() '$-3&'$() ( 3'0(+'$-3&'$() ( -$3$.

R(;,3)30&) *$+$ &) E;,3*&) M$0(+3$() B3&5913-& &

D3)*&)3034& M93-& ,)$&) & + (-&')0+ ,31&)

D(:( *+()('0$+ $(á) ( & ()0$:(-3& (' &) +(;,3)30&) $'0(+3&+()-(+ 03/3-$& (303& *&+ ,' ('0( $-+(30$& 3'0(+'$-3&'$('0( ;,( g$+$'03-( ;,(( D3)*&)3034& M93-& -,*( -&' &) +(;,3)30&) ( )(g,+3$, -$3$ (/3-$-3$.

E M3'3)0(+3& ( S$, ()0á /$-,0$& *$+$ +(43)$+ (' -,$;,3(+ 03(*& &)+(g3)0+&) ( D3)*&)3034&) M93-&) (303&) -&' ( /3' ( 4(+3/3-$+ )3 ( $-,(+&$ &) $4$'-() 09-'3-&) & -3('0/3-&) )( $' &3/3-$& $) ()*(-3/3-$-3&'() (&) 3)&) *&+ & ;,( *&+á )&3-30$+ $ &-,('0$-3' -&++()*&'3('0(.F(-$ ( 4('-33('0&H )($ -$,-3$ ( ()0(+33%$-3' 43$ <03.



11 DISEÑO METODOLOGICO

11.1 TIPO DE ESTUDIO H M&'&g+$/$

11.2 POBL ACIÓN.

T&&) &) &-,('0&) $;,3+3&) *$+$ +($3%$+ $ 3'4()03g$-3'

11. GESTION DEL D ATO

E ()$++&& ( &) &:(034&) )( &:)(+4$' $ & $+g& ( $ )3g,3('0(+(-&*3$-3' :3:3&g+á/3-$H

I'0(+'(0

- 00* H ./ ( $ - +( . &+g :& (0 3' : & (0 3' X 8 X " X :.0 - 00*H .$:( 4.- & .: + -&'0+&((3'/(--3&*$()0+$)8@.

- 00*H . 3'* + &0( -- 3&' ) & - 3$ .g & 4.- & 4 B( - &'0 ( '0 3 : + $ + 3' 3) 0( + 3&- 00*H .- & / (* +3 ).g &:. :, 3 : + & ) 1 "@.* / - 00*H .$ - 0$& & '0& & g3 -$ .-&.E3-3&'()20061E)0+$0(g3$) X -&'0+& X 3'.

- 00*H .:, ) *,: 3 - $.& +g .' 3& -.+(g,$-3'3')0+,-034&.*/

N&+$0343$

-R()&,-3' 1@" ( 2@@6-D(-+(0& "725 ( 2@@5-D(-+(0& "562 ( 2@@6

11." V ARI ABLES

R$%&'() ( +(,)&C$)3/3-$-3' ( +3()g&

I*&+0$'-3$ ( $ 903-$E/(-0&)

http://www.felacred.org/boletin/boletin_8_4_b.htlm











http://www.abev.com.br/



http://www.minproteccionsocial.gov.co/vBecontent/library/ministerio










http://www.cofepris.gob.mx/bu/libros/140.pdf












http://www.actaodontologica/


http://www.buspublica.org.ni/doc










11.5 OPERACIONALIACION DE V ARI ABLES

N+& 1(

&+ 1('

N&:+( V$+ 3$:2( U'31$1

1(M(131$

N$0,+ $2(%$ C$0(g&+ $) N34( 1(

5(13-38'

1 R$%&'() (+(,)&

N& -,$30$034$ C&)0&P+(),*,()0&R((:&)&D3)*&'3:33$

N&3'$

2 C$)3/3-$-3' (R3()g&

N& C,$30$034$ C$)( IC$)( IIAC$)( IIB

C$)( III

O+3'$

I*&+0$'-3$903-$

N& C,$30$034$ S3N&

N&3'$

" E/(-0&) N& C,$30$034$ C&*3-$-3&'() E;,3$S(g,+3$D(0(+3&+&

N&3'$

11.6 PLAN ? PROCESAMIENTO DE LA INFORM ACIÓN

L$ 3'/&+$-3' )( &:0,4& $ 0+$49) ( $0&) ;,( )( (0+$(+&' (I'0(+'(0 ( -3(+0&) $+0-,&) ),3'3)0+$&) *&+ ( A)()&+ C3('0/3-&

L$ /&+$ ( 0$:,$+ $ 3'/&+$-3' /,( +($3%$$ *&+ (3& ( $+(-&(--3' ( 4$+3$:() á) +((4$'0() ( *+&(-0& 3'4()03g$034&-&& R$%&'() ( +(,)&, -$)3/3-$-3' ( +3()g&, 3*&+0$'-3$ ( $903-$ (/(-0&) $4(+)&) 3*&+0$'-3$ ( $ '&+$0343$.



12 RESULT ADOS

D()*,9) ( $:(+ +($3%$& $ +(-&*3$-3' :3:3&g+$/3-$ )( &:)(+4$;,( $ 3'/&+$-3' (3)0('0( () , *&-$, (:3& $ ;,( '& $,-&) ()0,3&) $-(+-$ ( ( +(,)& ( 3)*&)3034&) &&'0&g3-&).

D( &) 6 $+0-,&) &-,('0&) $'$3%$&) )( ('-&'0+ ;,(H

U' 16Y ( & (& $-( +(/(+('-3$ $ $ 3*&+0$'-3$ ( $ 903-$ (+(,)&, $) +$%&'() ( +(,)& ( &) 3)*&)3034&) &&'0&g3-&)

(;,34$( $ 16Y , $ -$)3/3-$-3' ( +3()g& /,( ( Y *&+ <03& &) (/(-0&) ( +(,)& /,(+&' ( . Y.



1. CONCLUSIONES

1 S(g<' & (& *&(&) $/3+$+ ;,( $ )30,$-3' $-0,$ $-(+-$( $ +(,033%$-3' +(*+&-()$3('0& ( &) D3)*&)3034&)&&'0&g3-&) (' ',()0+& (3& () $,' $&+ $ +(/($&.

2 E +(*+&-()$3('0& ( &) 3/(+('0() 3)*&)3034&) () 3/-3 *&0('-3$('0( *(3g+&)&, *&+ (& 3-& *+&-(33('0& (:( )(+ (4$,$& )&(03& $ ,' -&'0+& +3g,+&)&.

$ 3*3(%$ ()0(+33%$-3' ( &) 3/(+('0() 3)*&)3034&)+(;,3(+(' ( ,' -&'&-33('0& *+(43& ( 3)&, () (43('0( ;,(()0( -&'&-33('0& & *+&*&+-3&'$ $ 3'/&+$-3' 09-'3-$ ;,(),3'3)0+$ ( /$:+3-$'0(.

" )( (:( 0('(+ $ -$*$-3$ ( (&)0+$+ -3('0/3-$('0( ;,( (+(,)& & +(*+&-()$3('0& ( &) 3)*&)334&) &&'0&g3-&) ())(g,+& *$+$ $ )$, ( &) ,),$+3&).



GLOS ARIO

1- REUSARH V&4(+ $ ,033%$+ $g&.

2- DISPOSITIVOSH )( ,033%$ )&& (' -&:3'$-3' -&' &0+&) 3)*&)3034&)M93-&) *$+$ $*&$+ , &3/3-$+ , ),)030,3+ & +()0$,+$+ /,'-3&'() & ()0+,-0,+$):3&g3-$) -&' 3+$) $ 0+$0$3('0& & $343& ( ,'$ ('/(+($ ()3' &3'-$*$-3$.

- BIOCOMPATIBILIDADH M$0(+3$ ;,( '& *+&4&-$ +($--3' $9+g3-$.

"- REPROCESAMIENTOH C,3$& $'0('33('0& ( ,' 3')0+,('0& *&+(3& ( $ ()3'/(--3' ()0(+33%$-3'.

5- FLEZIBILIDADH C$*$-3$ ( ,' -,(+*&, & $30$('0& ( &:$+)( )3'*(3g+& ( ;,( )( +&*$.

6 AD#ESIVOSH U'3' ( ,' $0(+3$ $ ,'$ ()0+,-0,+$.

7- CALIDADH E) ( +(),0$& 0&0$ ( $) -$+$-0(+)03-$) ( *+&,-0& )(+43-3&(' -,$'0& $, /$:+3-$-3' $'0('33('0& *&+ (3& ( $) -,$() ( *+&,-0& &)(+43-3& (' ,)& )$03)/$+á $) (*(-0$034$) ( -3('0(.

8- PIRÓGENESH S&' *+&,-0& :$-0(+3$'&).

!- ENDOTOZINASH S&' -&*&'('0() ;,( )( ('-,('0+$' (' $ (:+$'$(0(+3&+ ( $) :$-0(+3$) g+$ '(g$034$).

1@- TOZICIDADH L$ 0&3-3$ *,(( +(/(+3+)( $ (/(-0& )&:+( ,' &+g$'3)&-&*(0& -&& ,' )(+ ,$'& ,'$ :$-0(+3$ & 3'-,)& ,'$ *$'0$, & $ ,'$),:()0+,-0,+$.



11- EFECTIVIDADH C$*$-3$ ( &g+$+$ ( (/(-0& ;,( )( ()($.

12- INCIDENTEH #(-& & (4('0& ;,( *,(( $/(-0$+ $ )(g,+3$ *(+)&'$.

1- DISEMINACIÓNH E) -,$'& ,'$ 3'/(--3' )( $ $+((&+ ( $ 3)$á+($ & &05+$) ()0+,-0,+$) (:3& $ $) *&-$) (/(')$) &-$)3&'$'&3'0(+/(+('-3$ (' $ /,'-3' ( &) 0(3&) -(+-$'&).

1"- INOCULACIÓNH D(/3'3-3' ( 3'&-,$-3&' I'0+&,--3' 4&,'0$+3$ &$--3('0$ $ 0+$49) ( ,'$ (+3$, ( ,' g(+(' 3'/(-034& & ( ,'$ 4$-,'$ &(3-$('0&.

15- SUSCEPTIBILIDADH D(0(+3'$ $ *+&:$:33$ ( ;,( )( ()$++&( ,'$& -,$'& )( ()0á (*,()0& $ ,'$ &)3) (0(+3'$$ ,+$'0( ,' *(+&&()*(-3/3-$&.

16- RESERVORIOH U' +()(+4&+3& () ,' $'3$ *&+0$&+ ( ,' 3-+&&+g$'3)&;,( *+&4&-$ ,'$ ('/(+($ 3'/(--3&)$.



BIBLIOGRAFIA

1- MARLENE VALLEJO 03-$ ( +(,)&00*H .$:( 4.- & .: + -&'0+&((3'/(--3&*$()0+$)8@.

2- FELAC. F((+$-3' $03'&$(+3-$'$ ( -3+,g$, B&(0' P&)3-3' 09-'3-$ ($ ANDI -&' +()*(-0& $ +(*+&-()$3('0& ( D3)*&)3034&) M93-&) D3)($&)

P$+$ U' S&& U)&00* H ./ ( $ - +( .& +g :& (0 3':& (0 3' X 8 X "X :.0

00*H . 3'* + &0( -- 3& ' ) & - 3$ .g & 4.- & 4 B( - &'0( ' 0 3 : + $ + 3' 3) 0( +3 & ( $*+&0(--3' )&-3$ R(*<:3-$ ( C&&:3$ DECRETO "725 DE 2005, DECRETO"562 DE 2006, RESOLUCIÓN 1@" DE2006.

"- 00*H .- & / ( * +3 ).g &:. :, 3 : + & ) 1 "@ .* / . C$)3/3-$-3' ( D3)*&)3034&)S(g<' C$0(g&+$ D( R3()g& S$'30$+3&.

5- GUERRA ME, TOVAR E)0+$0(g3$) *$+$ ( -&'0+& ( I'/(--3&'()00*H .$ - 0$&&' 0& & g3 -$ .-&.E3-3&'()2@061E)0+$0(g3$) X -&'0+& X 3'.

6- 00*H .:, ) *,: 3- $.& +g .' 3& -.+(g,$-3'3')0+,-034&.*/ , I')0+,-034& P$+$( R(g3)0+& ( D3)*&)3034&) M93-&) O&'0&g3-&) & M$0(+3$() E;,3*&).

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Reuso Dispositivosen Odontologia Claudia Barrantes

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