AILC_ISO14971_2007.doc

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  Segunda edición 01-03-2007 Versión corregida 01-10-2007 Dispositivos médicos – Aplicación de la gestión de riesgos a los dispositivos médicos Matériel d'anesthésie et respiratoire — Compatibilité avec l'oxygène Licencia de INDECOPI a CNB Descargado: 1-0-200! Licencia so o #ara un usuario$ Se #ro%&'e a co#ia ( dis)ri'ución$ i NO*+, IN-E*N,CION,L ISO 14971 Número de referencia ISO 14971! 7#$% DOC.+EN-O P*O-E/IDO PO* LOS DE*EC0OS DE ,.-O* 1ISO 2007 -odos os derec%os reser2ados$
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    Segunda edición01-03-2007Versión corregida01-10-2007 Dispositivos médicos – Aplicación de la gestión de riesgos a los dispositivos médicos Matériel d'anesthésie et respiratoire — Compatibilité avec l'oxygène  Licencia de INDECOPI a CNBDescargado: 1-0-200!Licencia so o #ara un usuario$ Se #ro%&'e a co#ia ( dis)ri'ución$ i NO*+,INE*N,CION,L ISO14971 Número de referenciaISO 14971! 7#$%  DOC.+ENO P*OE/IDO PO* LOS DE*ECOS DE ,.O*ISO 2007 odos os derec%os reserados$ , enos 4ue se es#eci5i4ue o con)rario6 ninguna #ar)e de es)a#u' icación #uede ser re#roducida o u)i iada de ninguna 5ora o #or ning8n edio6 e ec)rónico oec9nico6 inc u(endo 5o)oco#ias o icro5i e6 sin #reia au)oriación #or escri)o de a ISO en a dirección4ue se indica a'ao o de organiso naciona de a ISO en e #a&s de so ici)an)e$ISO co#(rig%) o55iceCase #os)a e ; < C-1211 /enea 20 e $ = >1 22 7>! 01 11?a@ = >1 22 7>! 0! >7E-ai co#(rig%)Aiso$orge' $iso$orgI#reso en Suia Licencia de INDECOPI a CNBBaado: 1-0-200!Licencia so o #ara un usuario$ Se #ro%&'e a co#ia ( dis)ri'ución$ Descargo de &esponsa'ilidad Es)e arc%io PD? #uede con)ener carac)eres encri#)ados$ Con5ore a a #o &)ica de icencias de ,do'e6 es)e arc%io #uede ser i#reso o isua iado6 #ero no #uede ser edi)ado6 a enos 4ue os carac)eres encri#)ados cuen)en con a icencia #ara ains)a ación en a co#u)adora en a 4ue se rea iar9 a edición$ , descargar es)e arc%io6 as #ar)es ace#)an a res#onsa'i idad deno in5ringir a #o &)ica de icencias de ,do'e$ La Secre)ar&a Cen)ra de a ISO no asue res#onsa'i idad en es)e as#ec)o$ ,do'e es arca regis)rada de ,do'e S(s)es Incor#ora)ed$Los in5ores de os #roduc)os de so5)are usados #ara crear es)e arc%io PD? #ueden encon)rarse en In5oración /enera so'ree arc%io os #ar9e)ros de creación de PD? 5ueron o#)iiados #ara su i#resión$ De'e )ener cuidado #ara asegurarse de 4uee arc%io es a#ro#iado #ara e uso de organisos ie'ros de a ISO$ En e caso #oco #ro'a' e de 4ue sura un inconenien)e6#or 5aor6 in5ore a a Secre)ar&a Cen)ra en a dirección 4ue a#arece a'ao  ISO 14971! 7#$% Con)enido Pró ogo$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$iIn)roducción$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$1 , cance$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$12 rinos ( De5iniciones$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$13 *e4uisi)os genera es #ara a ges)ión de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$;3$1Proceso de a ges)ión de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$3$2*es#onsa'i idades de a ges)ión$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$73$3Co#e)encia de #ersona $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$F3$>P an de ges)ión de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$F3$;,rc%io de a ges)ión de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$!> ,n9 isis de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$!>$1Proceso de an9 isis de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$10>$2.so #reis)o e iden)i5icación de as carac)er&s)icas re acionadas a a seguridad de dis#osi)io dico$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$10>$3Iden)i5icación de #e igros$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$11>$>Es)iación de riesgoGsH #ara cada si)uación #e igrosa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$11; Ea uación de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$12 Con)ro de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$12$1*educción de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$12$2,n9 isis de a o#ción de con)ro de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$12$3I# een)ación de a edidaGsH de con)ro de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$13$>Ea uación de riesgo residua $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$13$;,n9 isis de riesgo'ene5icio$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$13$*iesgos 4ue surgen de edidas de con)ro de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$1>$7?ina iación de con)ro de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$1>7 Ea uación de a ace#)a'i idad de riesgo residua )o)a $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$1>F In5ore so're a ges)ión de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$1;! In5oración so're #roducción ( #os)#roducción$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$1; ,ne@o , Gin5ora)ioH ?undaen)o #ara os re4uisi)os$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$17 ,ne@o B Gin5ora)ioH /enera idades de #roceso de ges)ión de riesgos #ara os dis#osi)iosdicos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$27 ,ne@o C Gin5ora)ioH Pregun)as 4ue #ueden usarse #ara iden)i5icar as carac)er&s)icas de dis#osi)io dico 4ue #odr&a )ener un i#ac)o en a seguridad$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$2! ,ne@o D Gin5ora)ioH Conce#)os so're riesgos a# icados a os dis#osi)ios dicos$$$$$$$$$$$$$3 ,ne@o E Gin5ora)ioH Ee# os de #e igros6 secuencia de een)os #reisi' es ( si)uaciones#e igrosas$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$; ,ne@o ? Gin5ora)ioH P an de ges)ión de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$1 ,ne@o / Gin5ora)ioH In5oración so're as )cnicas de ges)ión de riesgos$$$$$$$$$$$$$$$$$$$$$$$$$$$$3 ,ne@o  Gin5ora)ioH /u&a so're ges)ión de riesgo en os dis#osi)ios dicos de diagnós)icoin i)ro$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$7 ,ne@o I GIn5ora)ioH /u&a so're e #roceso de an9 isis de riesgo #ara #e igros 'io ógicos$$$$$$F ,ne@o J Gin5ora)ioH In5oración de seguridad e in5oración so're riesgo residua $$$$$$$$$$$$$$$FFBi' iogra5&a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$!0 ii Licencia de INDECOPI a CNBBaado: 1-0-200!Licencia so o #ara un usuario$ Se #ro%&'e a co#ia ( dis)ri'ución$  (rólogo ISO GLa Organiación In)ernaciona #ara a Nora iaciónH es una ins)i)ución undia 4ue agru#a a os organisos naciona es #ara a nora iación Gie'ros ISOH$ E )ra'ao de #re#arar noras in)ernaciona es se rea ia6 nora en)e6 edian)e oscoi)s )cnicos de a ISO$ Cada ie'ro in)eresado en un )ea #ara e 4ue se %aes)a' ecido un coi) )cnico6 )iene derec%o a ser re#resen)ado en dic%o coi)$ Lasorganiaciones in)ernaciona es6 gu'ernaen)a es o no gu'ernaen)a es en cone@ióncon a ISO )a'in #ar)ici#an en e )ra'ao$ La ISO co a'ora6 es)rec%aen)e6 con aCoisión E ec)ro)cnica In)ernaciona GCEI o IEC  6 #or sus sig as en ing sH en )odos os asun)os de nora iación e ec)ro)cnica$Las Noras In)ernaciona es se e a'oran de acuerdo a as reg as dadas en a #ar)e 2de as Direc)ias de a ISOIEC$La )area #rinci#a de os coi)s )cnicos es #re#arar as noras in)ernaciona es$ Lasnoras in)ernaciona es e a'oradas 4ue %an sido ado#)adas #or os coi)s )cnicosson dis)ri'uidas a os ie'ros #ara o)ación$ Para a #u' icación de una NoraIn)ernaciona se re4uiere a a#ro'ación de a enos 7;K de os ie'ros 4ue ei)ensu o)o$ Se #res)a es#ecia a)ención a a #osi'i idad de 4ue a gunos e een)os de es)edocuen)o #uedan es)ar sue)os a os derec%os de #a)en)e$ La ISO no asuir9res#onsa'i idad #or a iden)i5icación de )odos ( cada uno de os derec%os de #a)en)e$E Coi) cnico ISOC 2106 Gestión de la calidad y aspectos generalescorrespondientes a los dispositivos médicos 6 ( e Su'coi) IECSC 2,6  Aspectoscomnes de los e!ipos eléctricos sados en la pr ctica médica 6 #re#araron aNora In)ernaciona ISO 1>!71$ E ,ne@o 6 /u&a so're a ges)ión de riesgos #aradis#osi)ios dicos de diagnós)ico in #itro M 5ue #re#arado #or a ISOC 2126 $reba de laboratorio cl%nico y sistemas de prebas de diagnóstico in vitro&  La segunda edición cance a ( ree# aa a a #riera edición GISO 1>!71:2000H6 as&coo a ersión odi5icada ISO 1>!71:2000,d$1:2003$Para 5ines de an)eniien)o 5u)uro de IEC6 e Su'coi) 2, %a decidido 4ue e con)enido de es)a #u' icación #eranecer9 ina )era' e %as)a a 5ec%a de resu )ado de an)eniien)o 1  4ue se indica en e si)io e' de IEC en a dirección%))#:e's)ore$iec$c% en a 5ec%a re acionada a a #u' icación es#ec&5ica$ En es)a5ec%a6 a #u' icación ser9-*econ5irada6-Cance ada6-*ee# aada #or una edición reisada6 o-+odi5icada$ Es)a ersión corregida de a ISO 1>!71:2007 incor#ora as siguien)es correcciones:-una ersión corregida de a ?igura 16 en a #9gina $ 1  Se so ici)a a os Coi)s Naciona es de IEC 4ue )engan en cuen)a 4ue a 5ec%a de resu )ado de an)eniien)o es e ao 201> #ara es)a #u' icación$ iii Licencia de INDECOPI a CNBBaado: 1-0-200! Licencia so o #ara un usuario$ Se #ro%&'e a co#ia ( dis)ri'ución
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