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TEST REPORT IEC 62304
Medi!l de"ie soft#!re Soft#!re life$yle proesses Report Repo rt %u&ber %u&ber'''' ''''''''''' ''''''''''''''''''''''''''': '''''''''''''''''''':
Enterr Client(s Ente Client(s Tes Testt Report Report %u&be %u&berr here here
)!te of issue''''''''''''''''''''''''''''''''''': Tot!l nu&ber of p!*es'''''''''''''''''''' +ppli!nt,s n!&e''''''''''''''''''''''''''': +ddress''''''''''''''''''''''''''''''''''''''''''': Test speifi!tion: St!nd!rd''''''''''''''''''''''''''''''''''''''''':
IEC 62304:2006 (First Edition)
Test Te st proedu proedure''' re''''''''''''''''''''''''''''''': '''''''''''''''''''''''''''':
Enterr Test Ente Test Proedu Proedure re %u&ber %u&ber here here
%on$st!nd!rd test ðod'''''''''''':
N/A
Test Te st Report -or& %o'''''''''''''''''''''' :
IEC62304B
Test Te st Report -or&.s/ Ori*in!tor''''': Ori*in!tor''' '':
IMQ S.p.A.
M!ster M!s ter TR-' TR-'''''''' '''''''''''''''''''''''''''''''''''': ''''''''''''''''''''''''''''':
Datd 20!3"02
Copyri*ht 2013 orld#ide Syste& for Confor&ity Testin* !nd Certifi!tion of Eletrotehni!l Euip&ent !nd Co&ponents .IECEE/ 5ene"! S#iterl!nd' +ll ri*hts reser"ed' #$is p%&'iation a* & rprod%d in +$o' or in part ,or non"oria' p%rposs as 'on- as t$ IECEE is ano+'d-d as op*ri-$t o+nr and so%r o, t$ atria'. IECEE tas no rsponsi&i'i t* ,or and +i'' not ass% 'ia&i'it* ,or daa-s rs%'tin,ro t$ radrs intrprtation o, t$ rprod%d atria' d% to its p'ant and ontt '
I, t$is #st 1port For is %sd &* non"IECEE &rs t$ IECEE/IEC 'o-o and t$ r,rn to t$ CB S$ prod%r s$a'' & rod. This report is not "!lid !s ! C7 Test Report unless si*ned by !n !ppro"ed C7 Testin* 8!bor!tory !nd !ppended to ! C7 Test Certifi!te issued by !n %C7 in !ord!ne #ith IECEE 02' Test ite& desription''''''''''''''''''''': Tr!de M!r9'''''''''''''''''''''''''''''''''''''': M!nuf!turer'''''''''''''''''''''''''''''''''': ModelType referene'''''''''''''''''''': R!tin*s'''''''''''''''''''''''''''''''''''''''''''':
a- 2 o, 24 1,rn so%r not ,o%nd
Testin* proedure !nd testin* lo!tion: C7 Testin* 8!bor!tory: Testin* Te stin* lo!tion !ddress'''''''''''''''''''''''': +ssoi!ted C7 Testin* 8!bor!tory: Testin* Te stin* lo!tion !ddress'''''''''''''''''''''''': Tested Te sted by .n!&e ; si*n!ture/''''''''' '': +ppro"ed +ppro" ed by .n!&e ; si*n!ture si*n!ture/'''''': /'''''': Testin* proedure: TMP Testin* Te stin* lo!tion !ddress'''''''''''''''''''''''': Tested Te sted by .n!&e ; si*n!ture/''''''''' '': +ppro"ed +ppro" ed by .n!&e ; si*n!ture si*n!ture/'''''': /'''''': Testin* proedure: MT Testin* Te stin* lo!tion !ddress'''''''''''''''''''''''': Tested Te sted by .n!&e ; si*n!ture/''''''''' '': itnessed by .n!&e ; si*n!ture/'''': +ppro"ed +ppro" ed by .n!&e ; si*n!ture si*n!ture/'''''': /'''''': Testin* proedure: SMT Testin* Te stin* lo!tion !ddress'''''''''''''''''''''''': Tested Te sted by .n!&e ; si*n!ture/''''''''' '': +ppro"ed +ppro" ed by .n!&e ; si*n!ture si*n!ture/'''''': /'''''': Super"ised Super" ised by .n!&e ; si*n!ture/'' ':
#1F No. IEC623045B
1port No. Error:
a- 3 o, 24
1port No. Error:
1,rn so%r not ,o%nd
8ist of +tt!h&ents .inludin* ! tot!l nu&ber of p!*es in e!h !tt!h&ent/:
Su&&!ry of testin*: Tests perfor&ed .n!&e of test !nd test l!use/:
Testin* lo!tion:
Su&&!ry of o&pli!ne #ith %!tion!l )ifferenes 8ist of ountries !ddressed:
The produt fulfils the reuire&ents of <<<<<<<<< .insert st!nd!rd nu&ber !nd edition !nd delete the te=t in p!renthesis or delete the #hole sentene if not !ppli!ble/
#1F No. IEC623045B
a- 4 o, 24
1port No. Error:
1,rn so%r not ,o%nd
Copy of &!r9in* pl!te The !rt#or9 belo# &!y be only ! dr!ft' The use of ertifi!tion &!r9s on ! produt &ust be !uthoried by the respeti"e %C7s th!t o#n these &!r9s'
#1F No. IEC623045B
Test ite& p!rtiul!rs''''''''''''''''''''''''''''''''''''''''' ''''''' : Cl!ssifi!tion of inst!ll!tion !nd use''''''''''''''''''''' : Type of end produt'''''''''''''''''''''''''''''''''''''''' ''''''''': End produt'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''': Tr!de&!r9'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''': End produt &odel !ndor type referene'''''''''''''': End produt &!nuf!turer'''''''''''''''''''''''''' '''''''''''' : End produt !ddress''''''''''''''''''''''''''''''''''''''''''''''': End produt r!tin*.s/'''''''''''''''''''''''''''''''''''''''''''' ''': Soft#!re desi*ner .if different th!n end produt &!n!*er/'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''': +ddress'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''': Method of identifi!tion of soft#!re .e'*' re"ision le"el d!te of rele!seissue/''''''''''''''''''''''''' '''''''''''' : Soft#!re l!ssifi!tion'''''''''''''''''''''''''''''''''''''''''''': A B C P!rtiul!r ris9s !ddressed by soft#!re'''''''''''''''''': Possible test !se "erdits: $ test !se does not !pply to the test ob>et''''''''''': N/A $ test ob>et does &eet the reuire&ent''''''''''''''''': (ass) $ test ob>et does not &eet the reuire&ent'''' ''' ''': F (Fai') Testin*'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''': )!te of reeipt of test ite&'''''''''''''''''''''''''''''''''''''': )!te .s/ of perfor&!ne of tests'''''''''''''''''''''''''''''' : 5ener!l re&!r9s: #$ tst rs%'ts prsntd in t$is rport r'at on'* to t$ o&t tstd. #$is rport s$a'' not & rprod%d pt in ,%'' +it$o%t t$ +rittn approa' o, t$ Iss%in- tstin'a&orator*. 7(S En'os%r 8)7 r,rs to additiona' in,oration appndd to t$ rport. 7(S appndd ta&')7 r,rs to a ta&' appndd to t$ rport. Throu*hout this report !
o&&!
point is used !s the dei&!l sep!r!tor'
M!nuf!turer,s )el!r!tion per sub$l!use 4'2'? of IECEE 02: #$ app'iation ,or o&tainin- a CB #st Crti,iat in'%ds or t$an on ,ator* 'oation and a d'aration ,ro t$ Man%,at%rr statin- t$at t$ sap'(s) s%&ittd ,or a'%ation is (ar) rprsntati o, t$ prod%ts ,ro a$ ,ator* $as &n proidd............................................................:
@es %ot !ppli!ble
hen differenes e=istA they sh!ll be identified in the 5ener!l produt infor&!tion setion'
%!&e !nd !ddress of f!tory .ies/''''''''''''''''''''''''':
5ener!l produt infor&!tion:
a- 9 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
4
5E%ER+8 REBIREME%TS
4.!
=A B C> #$ MAN?FAC#?1E1 o, MEDICA@ DE
4.2
=A B C> #$ MAN?FAC#?1E1 app'id a 1IS MANAEMEN# 1CESS op'*in- +it$ IS !49!.
4.3
=A B C> SF#A1E SAFE# C@ASSIFICA#IN
1s%'t " 1ar
a) #$ MAN?FAC#?1E1 assi-nd to a$ SF#A1E SS#EM a so,t+ar sa,t* 'ass (A B or C) aordinto t$ possi&' ,,ts on t$ patint oprator or ot$r pop' rs%'tin- ,ro a GAHA1D to +$i$ t$ SF#A1E SS#EM an ontri&%t. #$ so,t+ar sa,t* 'asss +r initia''* assi-nd &asd on srit* as ,o''o+s: C'ass A: No in%r* or daa- to $a't$ is possi&' C'ass B: Non"SE1I?S IN?1 is possi&' C'ass C: Dat$ or SE1I?S IN?1 is possi&' I, t$ GAHA1D o%'d aris ,ro a ,ai'%r o, t$ SF#A1E SS#EM to &$a as spi,id t$ pro&a&i'it* o, s%$ ,ai'%r +as ass%d to & !00 pr nt. I, t$ 1IS o, dat$ or SE1I?S IN?1 arisin- ,ro a so,t+ar ,ai'%r is s%&s%nt'* rd%d to an apta&' '' (as d,ind &* IS !49!) &* a $ard+ar 1IS CN#1@ as%r it$r &* rd%int$ ons%ns o, t$ ,ai'%r or &* rd%in- t$ pro&a&i'it* o, dat$ or SE1I?S IN?1 arisin- ,ro t$at ,ai'%r t$ so,t+ar sa,t* 'assi,iation a* & rd%d ,ro C to BJ I, t$ 1IS o, non" SE1I?S IN?1 arisin- ,ro a so,t+ar ,ai'%r is sii'ar'* rd%d to an apta&' '' &* a $ard+ar 1IS CN#1@ as%r t$ so,t+ar sa,t* 'assi,iation a* & rd%d ,ro B to A. &) #$ MAN?FAC#?1E1 assi-nd to a$ SF#A1E SS#EM t$at ontri&%ts to t$ ip'ntation o, a 1IS CN#1@ as%r a so,t+ar sa,t* 'ass &asd on t$ possi&' ,,ts o, t$ GAHA1D t$at t$ 1IS CN#1@ as%r is ontro''in-. ) #$ MAN?FAC#?1E1 do%ntd t$ so,t+ar sa,t* 'ass assi-nd to a$ SF#A1E SS#EM in t$ 1IS MANAEMEN# FI@E
<rdit
a- K o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
d) $n a SF#A1E SS#EM is doposd into SF#A1E I#EMS and +$n a SF#A1E I#EM is doposd into ,%rt$r SF#A1E I#EMS s%$ SF#A1E I#EMS in$rit t$ so,t+ar sa,t* 'assi,iation o, t$ ori-ina' SF#A1E I#EM (or SF#A1E SS#EM) %n'ss t$ MAN?FAC#?1E1 do%nts a rationa' ,or 'assi,iation into a di,,rnt so,t+ar sa,t* 'ass. A rationa' p'ains $o+ t$ n+ SF#A1E I#EMS ar s-r-atd so t$at t$* a* & 'assi,id sparat'* ) #$ MAN?FAC#?1E1 do%ntd t$ so,t+ar sa,t* 'ass o, a$ SF#A1E I#EM i, t$at 'ass is di,,rnt ,ro t$ 'ass o, t$ SF#A1E I#EM ,ro +$i$ it +as ratd &* doposition ,) $rr a 1CESS is r%ird ,or SF#A1E I#EMS o, a spi,i 'assi,iation and t$ 1CESS is nssari'* app'id to a -ro%p o, SF#A1E I#EMS t$ MAN?FAC#?1E1 %sd t$ 1CESSES and #ASS +$i$ ar r%ird &* t$ 'assi,iation o, t$ $i-$st" 'assi,id SF#A1E I#EM in t$ -ro%p %n'ss t$ MAN?FAC#?1E1 do%nts in t$ 1IS MANAEMEN# FI@E a rationa' ,or %sin- a 'o+r 'assi,iation -) For a$ SF#A1E SS#EM %nti' a so,t+ar sa,t* 'ass is assi-nd C'ass C r%irnts app'id
?
SO-T+RE )EDE8OPME%T PROCESS
L.!
SF#A1E DE
L.!.!
=A B C> #$ MAN?FAC#?1E1 sta&'is$d a so,t+ar d'opnt p'an (or p'ans) ,or ond%tin- t$ AC#I
DE@I
do%ntation) o, t$
AC#I
) #1ACEABI@I# &t+n SS#EM r%irnts so,t+ar r%irnts SF#A1E SS#EM tst and 1IS CN#1@ as%rs ip'ntd in so,t+ar
<rdit
a- o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
d) so,t+ar on,i-%ration and $an- ana-nt in'%din- S? CNFI?1A#IN I#EMS and so,t+ar %sd to s%pport d'opnt ) so,t+ar pro&' rso'%tion ,or $and'in- pro&'s dttd in t$ SF#A1E 1D?C#S DE@I
=A B C> #$ MAN?FAC#?1E1 %pdatd t$ p'an as d'opnt prods as appropriat
L.!.3
=A B C> So,t+ar d'opnt p'an r,rn to
SS#EM dsi-n
and d'opnt
a) As inp%ts ,or so,t+ar d'opnt SS#EM r%irnts ar r,rnd in t$ so,t+ar d'opnt p'an &* t$ MAN?FAC#?1E1 &) #$ MAN?FAC#?1E1 in'%dd or r,rnd in t$ so,t+ar d'opnt p'an prod%rs ,or oordinatin- t$ so,t+ar d'opnt and t$ dsi-n and d'opnt a'idation nssar* to satis,* 4.! L.!.4
=C> Assoiatd +it$ t$ d'opnt o, SF#A1E I#EMS o, 'ass C in t$ so,t+ar d'opnt p'an ar in'%dd or r,rnd: a) standards &) t$ods ) too's
L.!.L
=B C> #$ MAN?FAC#?1E1 in'%dd or r,rnd in t$ so,t+ar d'opnt p'an a p'an to int-rat t$ SF#A1E I#EMS (in'%din- S?) and pr,or tstind%rin- int-ration
L.!.6
=A B C> In t$ so,t+ar d'opnt p'an t$ ,o''o+inin'%dd or r,rnd: a) DE@I
a$ 'i, *'
AC#I
) i'stons at +$i$ t$
DE@I
d) t$ aptan ritria ,or
t$
DE@I
L.!.9
=A B C> #$ MAN?FAC#?1E1 in'%dd or r,rnd in t$ so,t+ar d'opnt p'an a p'an to ond%t t$ AC#I
L.!.K
=A B C> #$ MAN?FAC#?1E1 in'%dd or r,rnd in t$ so,t+ar d'opnt p'an in,oration a&o%t t$ do%nts to & prod%d d%rin- t$ so,t+ar d'opnt 'i, *'.
<rdit
a- !0 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
For a$ idnti,id do%nt or t*p o, do%nt t$ , o''o+in- in,oration %st & in'%dd or r,rnd: a) tit' na or nain- onntion &) p%rpos ) intndd a%din o, do%nt d) prod%rs and rsponsi&i'itis ,or d'opnt ri+ approa' and odi,iation L.!.
=A B C> #$ MAN?FAC#?1E1 in'%dd or r,rnd so,t+ar on,i-%ration ana-nt in,oration in t$ so,t+ar d'opnt p'an. #$ so,t+ar on,i-%ration ana-nt in,oration %st in'%d or r,rn: a) t$ 'asss t*ps at-oris or 'ists o, its to & ontro''d &) t$ so,t+ar on,i-%ration ana-nt AC#I
L.!.!0
1CESS is
to & %sd
=B C> #$ its to & ontro''d in'%d too's its or sttin-s %sd to d'op t$ MEDICA@ DE
L.!.!!
=B C> #$ MAN?FAC#?1E1 p'ans to p'a CNFI?1A#IN I#EMS %ndr do%ntd on,i-%ration ana-nt ontro' &,or t$* ar
L.2
SF#A1E 1EQ?I1EMEN#S ANA@SIS
L.2.!
=A B C> For a$ SF#A1E SS#EM o, t$ MEDICA@ DE
L.2.2
=A B C> As appropriat to t$ MEDICA@ in'%dd in t$ so,t+ar r%irnts:
DE
a) ,%ntiona' and apa&i'it* r%irnts &) SF#A1E SS#EM inp%ts and o%tp%ts ) intr,as &t+n t$ ot$r SS#EMS
SF#A1E SS#EM and
t$ MAN?FAC#?1E1
<rdit
a- !! o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
d) so,t+ar"drin a'ars +arnin-s and oprator ssa-s ) SEC?1I# r%irnts ,) %sa&i'it* n-inrin- r%irnts t$at ar snsiti to $%an rrors and trainin-) data d,inition and data&as r%irnts $) insta''ation and aptan r%irnts o, t$ d'ird MEDICA@ DE
=B C> #$ MAN?FAC#?1E1 in'%dd 1IS CN#1@ as%rs ip'ntd in so,t+ar ,or $ard+ar ,ai'%rs and potntia' so,t+ar d,ts in t$ r%irnts as appropriat to t$ MEDICA@ DE
L.2.4
=A B C> #$ MAN?FAC#?1E1 r"E
L.2.L
=A B C> #$ MAN?FAC#?1E1 ns%rs t$at istinr%irnts in'%din- SS#EM r%irnts ar r" E
L.2.6
=A B C> #$ MAN?FAC#?1E1 ri,id and do%ntd t$at t$ so,t+ar r%irnts: a) ip'nt SS#EM r%irnts in'%din- t$os r'atin- to 1IS CN#1@ &) do not ontradit on anot$r ) ar prssd in trs t$at aoid a&i-%it* d) ar statd in trs t$at prit sta&'is$nt o, tst ritria and pr,oran o, tsts to dtrin +$t$r t$ tst ritria $a &n t ) an & %ni%'* idnti,id ,) ar traa&' to so%r
L.3
SS#EM r%irnts or ot$r
SF#A1E A1CGI#EC#?1A@ DESIN
<rdit
a- !2 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
L.3.!
=B C> #$ MAN?FAC#?1E1 trans,ord t$ r%irnts ,or t$ MEDICA@ DE
L.3.2
=B C> #$ MAN?FAC#?1E1 d'opd and do%ntd an A1CGI#EC#?1E ,or t$ intr,as &t+n t$ SF#A1E I#EMS and t$ oponnts trna' to t$ SF#A1E I#EMS (&ot$ so,t+ar and $ard+ar) and &t+n t$ SF#A1E I#EMS
L.3.3
=B C> I, a SF#A1E I#EM is idnti,id as S? t$ MAN?FAC#?1E1 spi,id ,%ntiona' and pr,oran r%irnts ,or t$ S? it t$at ar nssar* ,or its intndd %s
L.3.4
=B C> I, a SF#A1E I#EM is idnti,id as S? t$ MAN?FAC#?1E1 spi,id t$ SS#EM $ard+ar and so,t+ar nssar* to s%pport t$ propr opration o, t$ S? it
L.3.L
=C> #$ MAN?FAC#?1E1 idnti,id t$ s-r-ation &t+n SF#A1E I#EMS t$at is ssntia' to 1IS CN#1' and stat $o+ to ns%r t$at t$ s-r-ation is ,,ti
L.3.6
=B C> #$ MAN?FAC#?1E1 ri,id and do%nt t$at:
1s%'t " 1ar
a) t$ A1CGI#EC#?1E o, t$ so,t+ar ip'nts SS#EM and so,t+ar r%irnts in'%din- t$os r'atin- to 1IS CN#1@ &) t$ so,t+ar A1CGI#EC#?1E is a&' to s%pport intr,as &t+n SF#A1E I#EMS and &t+n SF#A1E I#EMS and $ard+ar ) t$ MEDICA@ DE
SF#A1E DE#AI@ED DESIN =B C> #$ MAN?FAC#?1E1 r,ind t$ so,t+ar it is rprsntd &* SF#A1E
A1CGI#EC#?1E %nti' ?NI#S
L.4.2
=C> #$ MAN?FAC#?1E1 d'opd and do%ntd a dtai'd dsi-n ,or a$ SF#A1E ?NI# o, t$ SF#A1E I#EM
L.4.3
=C> #$ MAN?FAC#?1E1 d'opd and do%ntd a dtai'd dsi-n ,or an* intr,as &t+n t$ SF#A1E ?NI# and trna' oponnts ($ard+ar or so,t+ar) as +'' as an* intr,as &t+n SF#A1E ?NI#S
L.4.4
=C> #$ MAN?FAC#?1E1 ri,id and do%ntd t$at t$ so,t+ar dtai'd dsi-n: a) ip'nts t$ so,t+ar A1CGI#EC#?1E
<rdit
a- !3 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
&) is ,r ,ro ontradition +it$ t$ so,t+ar A1CGI#EC#?1E
L.L
SF#A1E ?NI# IM@EMEN#A#IN AND
L.L.!
=A B C> #$ MAN?FAC#?1E1 ip'ntd a$ SF#A1E ?NI#
L.L.2
=B C> #$ MAN?FAC#?1E1 sta&'is$d strat-is t$ods and prod%rs ,or ri,*in- a$ SF#A1E ?NI#
$r
=B C> #$ MAN?FAC#?1E1 sta&'is$d aptan ritria ,or SF#A1E ?NI#S prior to int-ration into 'ar-r SF#A1E I#EMS as appropriat and ns%r t$at SF#A1E ?NI#S t aptan ritria
L.L.4
=C> $n prsnt in t$ dsi-n t$ ritria as appropriat ,or:
MAN?FAC#?1E1 in'%dd additiona' aptan
a) propr nt s%n &) data and ontro' ,'o+ ) p'annd rso%r a''oation d) ,a%'t $and'in- (rror d,inition iso'ation and ror*) ) initia'isation o, aria&'s ,) s',"dia-nostis -) or* ana-nt and or* or,'o+s $) &o%ndar* onditions L.L.L
=B C> #$ MAN?FAC#?1E1 pr,ord t$ SF#A1E ?NI#
L.6
SF#A1E IN#E1A#IN AND IN#E1A#IN #ES#IN
L.6.!
=B C> #$ MAN?FAC#?1E1 int-ratd t$ SF#A1E ?NI#S in aordan +it$ t$ int-ration p'an (s L.!.L)
L.6.2
=B C> #$ MAN?FAC#?1E1 ri,id and rordd t$ ,o''o+in- aspts o, t$ so,t+ar int-ration in aordan +it$ t$ int-ration p'an (s L.!.L): a) t$
SF#A1E ?NI#S $a &n
int-ratd into
SF#A1E I#EMS and t$ SF#A1E SS#EM
&) t$ $ard+ar its SF#A1E I#EMS and s%pport ,or an%a' oprations o, t$ SS#EM $a &n int-ratd into t$ SS#EM L.6.3
=B C> #$ MAN?FAC#?1E1 tstd t$ int-ratd SF#A1E I#EMS in aordan +it$ t$ int-ration p'an (s L.!.L) and do%ntd t$ rs%'ts
<rdit
a- !4 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
L.6.4
=B C> For so,t+ar int-ration tstin- t$ MAN?FAC#?1E1 addrssd +$t$r t$ int-ratd SF#A1E I#EM pr,ors as intndd
L.6.L
=B C> #$ MAN?FAC#?1E1 E
L.6.6
=B C> $n so,t+ar its ar int-ratd t$ MAN?FAC#?1E1 ond%td 1E1ESSIN #ES#IN appropriat to donstrat t$at d,ts $a not &n introd%d into prio%s'* int-ratd so,t+ar
L.6.9
=B C> #$ MAN?FAC#?1E1: a) do%ntd t$ tst rs%'t (pass/,ai' and a 'ist o, ANMA@IES) &) rtains s%,,iint rords to prit t$ tst to & rpatd ) idnti,id t$ tstr
L.6.K
=B C> #$ MAN?FAC#?1E1 ntrd ANMA@IES ,o%nd d%rin- so,t+ar int-ration and int-ration tstin- into a so,t+ar pro&' rso'%tion 1CESS
L.9
SF#A1E SS#EM #ES#IN
L.9.!
=B C> #$ MAN?FAC#?1E1 sta&'is$d and pr,ord a st o, tsts prssd as inp%t sti%'i ptd o%tos pass/,ai' ritria and prod%rs ,or ond%tin- SF#A1E SS#EM tstin- s%$ t$at a'' so,t+ar r%irnts ar ord
L.9.2
=B C> #$ MAN?FAC#?1E1 ntrd ANMA@IES ,o%nd d%rin- so,t+ar s*st tstin- into a so,t+ar pro&' rso'%tion 1CESS
L.9.3
=B C> $n $an-s ar ad d%rinMAN?FAC#?1E1:
SF#A1E SS#EM tstin-
a) rpatd tsts pr,or odi,id tsts or pr,or additiona' tsts as appropriat to ri,* t$ ,,tinss o, t$ $an- in orrtin- t$ pro&' &) ond%td tstin- appropriat to donstrat t$at %nintndd sid ,,ts $a not &n introd%d ) pr,ord r'ant d,ind in 9.4 L.9.4
1IS MANAEMEN# AC#I
=B C> #$ MAN?FAC#?1E1 ri,id t$at: a) t$
t$
<rdit
a- !L o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
d) tst rs%'ts t t$ r%ird pass/,ai' ritria L.9.L
=B C> #$ MAN?FAC#?1E1: a) do%nt t$ tst rs%'t (pass/,ai' and a 'ist o, ANMA@IES)
&) rtain s%,,iint rords to prit t$ tst to & rpatd ) idnti,* t$ tstr L.K
SF#A1E 1E@EASE
L.K.!
=B C> #$ MAN?FAC#?1E1 ns%rd t$at so,t+ar
L.K.2
=B C> #$ MAN?FAC#?1E1 do%ntd a'' no+n rsid%a' ANMA@IES
L.K.3
=B C> #$ MAN?FAC#?1E1 ns%rd t$at a'' no+n rsid%a' ANMA@IES $a &n E
L.K.4
=A B C> #$ MAN?FAC#?1E1 do%ntd t$
L.K.L
=B C> #$ MAN?FAC#?1E1 do%ntd t$ prod%r and nironnt %sd to rat t$ r'asd so,t+ar
L.K.6
=B C> #$ MAN?FAC#?1E1 ns%rd t$at a'' AC#I
L.K.9
=B C> For at 'ast a priod o, ti dtrind as t$ 'on-r o,: t$ 'i, ti o, t$ di as d,ind &* t$ MAN?FAC#?1E1 or a ti spi,id &* r'ant r-%'ator* r%irnts t$ MAN?FAC#?1E1 ar$id: a) t$
SF#A1E 1D?C# and CNFI?1A#IN I#EMS
&) t$ do%ntation L.K.K
=B C> #$ MAN?FAC#?1E1 sta&'is$d prod%rs to ns%r t$at t$ r'asd SF#A1E 1D?C# an & r'ia&'* d'ird to t$ point o, %s +it$o%t orr%ption or %na%t$orisd $an- #$s prod%rs addrssd t$ prod%tion and $and'in- o, dia ontainin- t$ SF#A1E 1D?C# in'%din- as appropriat: O rp'iation O dia 'a&''in O paa-in O prottion O stora- O d'ir*
<rdit
a- !6 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
6
SO-T+RE M+I%TE%+%CE PROCESS
6.!
=A B C> #$ MAN?FAC#?1E1 sta&'is$d a so,t+ar aintnan p'an (or p'ans) ,or ond%tin- t$ AC#I
MEDICA@ DE
&) ritria ,or dtrinin- +$t$r ,d&a is onsidrd to & a pro&' ) %s o, t$ so,t+ar
1IS MANAEMEN# 1CESS
d) %s o, t$ so,t+ar pro&' rso'%tion 1CESS ,or ana'*sin- and rso'in- pro&'s arisin- a,tr r'as o, t$ MEDICA@ DE
E
O %p-rads O &%- ,is O pat$s O o&so'sn 6.2
1B@EM AND MDIFICA#IN ANA@SIS
6.2.!
DC?MEN# AND E
6.2.!.!
=A B C> #$ MAN?FAC#?1E1 onitors ,d&a on r'asd SF#A1E 1D?C# ,ro &ot$ insid its o+n or-aniation and ,ro %srs
6.2.!.2
=A B C> Fd&a is do%ntd and E
at%a' or potntia' adrs nts and diations ,ro spi,iations
<rdit
a- !9 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
6.2.!.3
=A B C> Ea$ 1B@EM 1E1# is E
6.2.2
=A B C> #$ MAN?FAC#?1E1 %ss t$ so,t+ar pro&' rso'%tion 1CESS (s C'a%s ) to addrss 1B@EM 1E1#S
6.2.3
=B C> In addition to t$ ana'*sis r%ird &* C'a%s t$ MAN?FAC#?1E1 ana'*ss a$ CGANE 1EQ?ES# ,or its ,,t on t$ or-aniation r'asd SF#A1E 1D?C#S and SS#EMS +it$ +$i$ it intr,as
6.2.4
=A B C> #$ MAN?FAC#?1E1 E
1s%'t " 1ar
1D?C#S
6.2.L
=A B C> #$ MAN?FAC#?1E1 idnti,is t$ approd CGANE 1EQ?ES#S t$at a,,t r'asd SF#A1E 1D?C#S
As r%ird &* 'oa' r-%'ation t$ MAN?FAC#?1E1 in,ord %srs and r-%'ators a&o%t: a) an* pro&' in r'asd SF#A1E 1D?C#S and t$ ons%ns o, ontin%d %n$an-d %s &) t$ nat%r o, an* aai'a&' $an-s to r'asd SF#A1E 1D?C#S and $o+ to o&tain and insta'' t$ $an-s 6.3
MDIFICA#IN IM@EMEN#A#IN
6.3.!
=A B C> #$ MAN?FAC#?1E1 %sd t$ so,t+ar d'opnt 1CESS (s C'a%s L) or an sta&'is$d aintnan 1CESS to ip'nt t$ odi,iations
6.3.2
=A B C> #$ MAN?FAC#?1E1 r'asd odi,id SF#A1E SS#EMS aordin- to L.K. Modi,iations a* & r'asd as part o, a ,%'' r"r'as o, a SF#A1E SS#EM or as a odi,iation it oprisin$an-d SF#A1E I#EMS and t$ nssar* too's to insta'' t$ $an-s as odi,iations to an istinSF#A1E SS#EM.
SO-T+RE RISF M+%+5EME%T PROCESS
9.!
ANA@SIS F SF#A1E CN#1IB?#IN # GAHA1D?S SI#?A#INS
9.!.!
=B C> #$ MAN?FAC#?1E1 idnti,id SF#A1E I#EMS t$at o%'d ontri&%t to a $aardo%s sit%ation idnti,id in t$ MEDICA@ DE
<rdit
a- !K o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
9.!.2
=B C> #$ MAN?FAC#?1E1 idnti,id potntia' a%ss o, t$ SF#A1E I#EM idnti,id a&o ontri&%tin- to a $aardo%s sit%ation #$ MAN?FAC#?1E1 onsidrd potntia' a%ss in'%din- as appropriat: a) inorrt or inop't spi,iation o, ,%ntiona'it* &) so,t+ar d,ts in t$ idnti,id SF#A1E I#EM ,%ntiona'it* ) ,ai'%r or %nptd rs%'ts ,ro
S?
d) $ard+ar ,ai'%rs or ot$r so,t+ar d,ts t$at o%'d rs%'t in %nprdita&' so,t+ar opration ) rasona&'* ,orsa&' is%s 9.!.3
=B C> I, ,ai'%r or %nptd rs%'ts ,ro S? is a potntia' a%s o, t$ SF#A1E I#EM ontri&%tin- to a $aardo%s sit%ation t$ MAN?FAC#?1E1 E
9.!.4
=B C> #$ MAN?FAC#?1E1 do%ntd in t$ 1IS MANAEMEN# FI@E potntia' a%ss o, t$ SF#A1E I#EM ontri&%tin- to a $aardo%s sit%ation (s IS !49!)
9.!.L
=B C> #$ MAN?FAC#?1E1 do%ntd in t$ 1IS MANAEMEN# FI@E s%ns o, nts t$at o%'d rs%'t in a $aardo%s sit%ation t$at ar idnti,id in 9.!.2
9.2
1IS CN#1@ MEAS?1ES
9.2.!
=B C> For a$ potntia' a%s o, t$ so,t+ar it ontri&%tin- to a $aardo%s sit%ation do%ntd in t$ ris ana-nt ,i' t$ an%,at%rr d,ind and do%ntd ris ontro' as%rs
9.2.2
=B C> I, a 1IS CN#1@ as%r is ip'ntd as part o, t$ ,%ntions o, a SF#A1E I#EM t$ MAN?FAC#?1E1: a) in'%dd t$ r%irnts
1IS CN#1@ as%r
in t$ so,t+ar
&) assi-nd a so,t+ar sa,t* 'ass to t$ SF#A1E I#EM &asd on t$ possi&' ,,ts o, t$ GAHA1D t$at t$ 1IS CN#1@ as%r is ontro''in) d'opd t$ C'a%s L 9.3
SF#A1E I#EM in
aordan +it$
<rdit
a- ! o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
9.3.!
=B C> #$ ip'ntation o, a$ 1IS CN#1@ as%r do%ntd in 9.2 +as
9.3.2
=B C> I, a 1IS CN#1@ as%r is ip'ntd as a SF#A1E I#EM t$ MAN?FAC#?1E1 E
9.3.3
=B C> #$ MAN?FAC#?1E1 do%ntd appropriat: a) ,ro t$ $aardo%s sit%ation to t$ &) ,ro t$ a%s
SF#A1E I#EM to
#1ACEABI@I# o,
so,t+ar
GAHA1DS as
SF#A1E I#EM
t$ spi,i so,t+ar
) ,ro t$ so,t+ar a%s to t$ as%r
1IS CN#1@
d) ,ro t$ 1IS CN#1@ as%r to t$ o, t$ 1IS CN#1@ as%r
9.4
1IS MANAEMEN# F SF#A1E CGANES
9.4.!
=A B C> #$ MAN?FAC#?1E1 ana'*sd $an-s to t$ (in'%din- S?) to dtrin +$t$r:
MEDICA@ DE
a) additiona' potntia' a%ss ar introd%d ontri&%tin- to a $aardo%s sit%ation &) additiona' so,t+ar r%ird
1IS CN#1@ as%rs
ar
9.4.2
=B C> #$ MAN?FAC#?1E1 ana'*sd $an-s to t$ so,t+ar in'%din- $an-s to S? to dtrin +$t$r t$ so,t+ar odi,iation o%'d intr,r +it$ istin- 1IS CN#1@ as%rs
9.4.3
=B C> #$ MAN?FAC#?1E1 pr,ord r'ant 1IS MANAEMEN# AC#I
G
SO-T+RE CO%-I5R+TIO% M+%+5EME%T PROCESS
K.!
Con,i-%ration idnti,iation
K.!.!
=A B C> #$ MAN?FAC#?1E1 sta&'is$d a s$ ,or t$ %ni% idnti,iation o, CNFI?1A#IN I#EMS and t$ir
K.!.2
=A B C> For a$ S? CNFI?1A#IN I#EM &in- %sd in'%din- standard 'i&raris t$ MAN?FAC#?1E1 do%ntd: a) t$ tit'
<rdit
a- 20 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st &) t$
1s%'t " 1ar
MAN?FAC#?1E1
) t$ %ni%
S? dsi-nator
K.!.3
=A B C> #$ MAN?FAC#?1E1 do%ntd t$ st o, CNFI?1A#IN I#EMS and t$ir
K.2
CGANE CN#1@
K.2.!
=A B C> #$ MAN?FAC#?1E1 $an-d CNFI?1A#IN I#EMS on'* in rspons to an approd CGANE 1EQ?ES#
K.2.2
=A B C> #$ MAN?FAC#?1E1 ip'ntd t$ $an- as spi,id in t$ CGANE 1EQ?ES# #$ MAN?FAC#?1E1 idnti,id and pr,ord an* nds to & rpatd as a rs%'t o, t$ $an- in'%din- $an-s to t$ so,t+ar sa,t* 'assi,iation o, SF#A1E SS#EMS and SF#A1E
AC#I
I#EMS
K.2.3
=A B C> #$ MAN?FAC#?1E1 ri,id t$ $an- in'%din- rpatin- an*
K.2.4
=A B C> #$ MAN?FAC#?1E1 ratd an a%dit trai' +$r an & trad a$: a) CGANE 1EQ?ES# &) r'ant
1B@EM 1E1#
) approa' o, t$
CGANE 1EQ?ES#
K.3
=A B C> #$ MAN?FAC#?1E1 rtains rtria&' rords o, t$ $istor* o, ontro''d CNFI?1A#IN I#EMS in'%din- SS#EM on,i-%ration
H
SO-T+RE PRO78EM RESO8TIO% PROCESS
.!
=A B C> #$ MAN?FAC#?1E1 prpard a 1B@EM 1E1# ,or a$ pro&' dttd in a SF#A1E 1D?C# 1B@EM 1E1#S +r
'assi,id as ,o''o+s:
a) t*p &) sop ) ritia'it* .2
=A B C> #$ MAN?FAC#?1E1: a) insti-atd t$ pro&' and i, possi&' idnti,* t $ a%ss &) E
<rdit
a- 2! o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
) do%ntd t$ o%to o, t$ insti-ation and a'%ation d) ratd a CGANE 1EQ?ES#(S) ,or ations ndd to orrt t$ pro&' or do%nt t$ rationa' ,or tain- no ation .3
=A B C> #$ MAN?FAC#?1E1 adisd r'ant partis o, t$ istn o, t$ pro&' as appropriat
.4
=A B C> #$ MAN?FAC#?1E1 approd and ip'ntd a'' CGANE 1EQ?ES#S o&srin- t$ r%irnts o, t$ $an- ontro' 1CESS (s K.2)
.L
=A B C> #$ MAN?FAC#?1E1 aintains rords o, 1B@EM 1E1#S and t$ir rso'%tion in'%din- t$ir
#$ MAN?FAC#?1E1 %pdatd t$ FI@E as appropriat (s 9.4)
1IS MANAEMEN#
.6
=A B C> #$ MAN?FAC#?1E1 pr,ord ana'*sis to dtt trnds in 1B@EM 1E1#S
.9
=A B C> #$ MAN?FAC#?1E1 ri,id rso'%tions to dtrin +$t$r: a) pro&' $as &n rso'd and t$ 1E1# $as &n 'osd
1B@EM
&) adrs trnds $a &n rrsd ) CGANE 1EQ?ES#S $a &n ip'ntd in t$ appropriat SF#A1E 1D?C#S and AC#I
=A B C> $n tstin- rtstin- or 1E1ESSIN #ES#IN SF#A1E I#EMS and SS#EMS ,o''o+in- a $an- t$ MAN?FAC#?1E1 in'%dd in t$ tst do%ntation: a) tst rs%'ts &) ANMA@IES ,o%nd ) t$
<rdit
a- 22 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
<rdit
T+78E: M!ppin* of reuired e"idene !nd &!nuf!turer dou&ents Standard C'a%s
D'ira&'s
4.2
1is ana-nt ,i'
4.3
So,t+ar sa,t* 'assi,iation do%nt
L.!.!
So,t+ar d'opnt p'an
L.!.3
So,t+ar r%irnts r,rn to so,t+ar dsi-n and d'opnt do%nt
L.!.4
D'opnt standards t$ods and too's rords ,or 'ass C so,t+ar
L.!.L
So,t+ar int-ration and int-ration tstin- p'an
L.!.6
So,t+ar ri,iation p'an
L.!.9
So,t+ar ris ana-nt p'an
L.!.K
Do%nt ana-nt prod%rs
L.!.
So,t+ar on,i-%ration ana-nt prod%rs
L.2
So,t+ar s*st r%irnts spi,iation
L.3
So,t+ar s*st ar$itt%r dsi-n spi,iation
L.3
So,t+ar it ar$itt%r dsi-n spi,iation
L.4
So,t+ar it dtai'd dsi-n spi,iation
L.4
So,t+ar %nit dtai'd dsi-n spi,iation
L.L.!
So,t+ar %nit ip'ntation rords
L.L.2
So,t+ar %nit ri,iation pross
L.L.3
So,t+ar %nit aptan ritria
L.L.L
So,t+ar %nit ri,iation rords
#it'
1ision 8
Dat
a- 23 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
<rdit
T+78E: M!ppin* of reuired e"idene !nd &!nuf!turer dou&ents Standard C'a%s
D'ira&'s
L.6.!
So,t+ar %nit int-ration pross
L.6.2
So,t+ar %nit int-ration rords
L.6.4
So,t+ar %nit int-ration tstin- rords
L.6.L
Ea'%ation o, so,t+ar %nit int-ration tst
L.6.6
So,t+ar %nit r-rssion tstin- pross
L.6.9
So,t+ar %nit r-rssion tstin- rords
L.6.K
So,t+ar pro&' rso'%tion pross
L.9
So,t+ar s*st tstinpross
L.K
So,t+ar s*st r'as pross
6.!
So,t+ar aintnan p'an
6.2.!
So,t+ar do%nt and a'%at ,d&a pross
6.2.!
So,t+ar pro&' rports
6.2.2
So,t+ar pro&' rso'%tion pross addrssd to pro&' rports
6.2.3
C$an- r%sts pross
6.2.L
Co%niation to %sr and r-%'ators pross
9.!
So,t+ar $aard ana'*sis pross
9.!
S? anoa'* 'ists
9.2
1is ontro' pross
9.3
1is ontro' ri,iation pross
9.4
1is ana-nt o, so,t+ar $an- pross
K.!
Con,i-%ration idnti,iation rord
#it'
1ision 8
Dat
a- 24 o, 24
1port No. Error:
1,rn so%r not ,o%nd IEC 62304 C'a%s
1%irnt ; #st
1s%'t " 1ar
<rdit
T+78E: M!ppin* of reuired e"idene !nd &!nuf!turer dou&ents Standard C'a%s
D'ira&'s
K.2
C$an- ontro' pross
So,t+ar pro&' rso'%tion pross
Supple&ent!ry infor&!tion:
#it'
1ision 8
Dat
