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f,nec, 26.1I.2014 r., B rpaA Bezuaxo Trpnoeo B r43rblHeHrze Ha
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P3VI - Bezrzxo TrpnoBo, B 10.30 qaca, KoMHCHa B c'bcraB: rpeAceAarel r4Hx(.
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MtrAI4I-U4HCKA AIAPATyPA" OOA, rpaA Bapna.
Bcexrz e4r4:r. or r{AeHoBere Ha KoMl4clztrra, [peAr4 3afror{BaHe Ha cBogra
pa6o'ra roAnlrca AeKlapaqLrs no .rn. 101r, att.2 or 3OII BbB Bp. c .rn.35, al. 1,
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HoMep, Aara H r{ac Ha rroAaBaHe. KovrprcprflTa KoHcTarvrpa, qe HsMa
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IIpu 3a[or{BaHe pa6orara Ha KoMr,rcH trra He rrpr4ctcrBar
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Ap.
Ilpe4n orBapsHe Ha o$eprure
3anoeeATa Ha !,upextopa Ha P3I4
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Benuro TrpHoeo 3a orKpHBaHe Ha
KoMHCrz
rpoqeAypara, BKArorrBauIa H MeroAz.Kara Ha oqeHsBaHe na oQeprr4Te.
Czre4, yCTaHOBgBaHe Ha lOpeIz3AO>KeHOTO KOMI4CH flTa HpI4CTbrII4 Kt,M
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O$epra 1: ex.
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or 3OII; PeSepeHqus 8 6p.; AAuuuacTpar;z.Buu
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flexaapar\un, o6pa3eq No10; Texnu.recKa o$epta; EO Ceptrz$HKar;
Ler<aaparJnfl,3a ctorBercrBrae; fl,exzrapaqvs 3a cborBercrBvre Ha npoAyKTvrre,
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I,lsrvreueHae 2OO7 147 IEO; OropH3aqHoHHo rrrzcMo; CepT aQarar ISO
13485:2003 a ISO 9001:2008 Ha HMero Ha npor43BoAHTeAs; Ceprn$rzxaT sa
cborBercrBae ISO 9001:2008 Ha )rqacrHaKa; PasperreHHe 3a rtproBafl Ha
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Texna.recKa o$epta; CepruQraxar ISO 13485:2003 Ha HMero Ha
npol,r3B o4vrretfl,; CE Cep'ra$vrKar 3a c'borBercrBue Ha npoAyKTr4Te,
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Cep'rra$HKar 3a cborBercrBae ISO 9001:2008 Ha ) racrHaKa; PasperueHue 3a
MeA,HqutHCKrz vr34e^vrfl. per. NqIV-P-T lMI4
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AoKyMeHTaqHs Ha arapaTa.
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AoKyMeHTHTe, cbAbp>Karqz ce B o$eptara na QrzpMara; Y.qoc':roBepeHne 3a
aKTyaAHo cbcrosHae - 3aBepeHo or yrtpaBr4Tels Konr4e; f,exnapat\vr{ orHocHo
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MeAHLIHHCKa anaparypa; Cuncm Ha Auqara, orroBapgu{n 3a r,r3[blHeHaero
Ha flopbrrKaTa, Br(AIorrHTeAHo Ha Te3H, OTroBapeqa 3a KoHTpoAa Ha
KarrecrBoro; Cepta$HKar 3a cepBH3Ho o6yrenae 2 6p.; fexnapar\vs, 3a
H3nbAHeHH OT yr{aCTHI.IKa AOTOBOpH, CXOAHH C npeAMeTa Ha nopbr{KaTa;
Pe$epeHql4s 5 6p.; I4HSopMaqHs 3a r4srrtlHeHrzero or POII 2 6p.;
A4uraurzcrparvrBHr4 cBeAeHkrfl.; flexnapar\vs, orHocHo Ar4rrcara Ha
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3OII; flexnapat\vrfl, no.rn.47, az^.9 ot 3OII; flexzrapar\vrfl. rro rrn.56, alr. 1, T.8 o'r
3OlI; flexzrapari:vrn, o6paseq Nq10; Texnrz.recKa o$epta; Cepru@wwar ISO
13485:2003 Ha r4Mero Ha rrpoa3BoAuTen-s; Cepra$zxar 3a cborBercrBrae ISO
9001:2008 Ha yr{acrHr4Ka; PasperueHue 3a rbproBkrfl. Ha eApo c MeAHqr4HCKr4
vr31e^r4n per. NqIV-P-f |MIA -279 125.01.2008 r. u rpurlo>KeHae KbM Hero;
flexnapat\vrfl. or ynpaBr{Tel-rr; Ceprn$nxar 3a ctorBercrBvre Ha rrpoAyKTvrre,
orroBapsrql.r ua frupeKTr4Ba 93 I 42 IE,I O orHocHo MeAraqHHcKHTe vrcAe^vfl;
f,exlapar\vrfl.3a cborBercrBue; OSrzqrzaAHH AorryMeHTrz or rrpou3Bo1vrrelrr 3a
TexHHrrecKr4Te xapaKTepvrcTvrKH Ha anapaTa, MoAeA r4 AaTa Ha [poa3BoACTBo,
cHr4MKa Ha alapara, rrtlHo o[prcaHue, 6poruypra vr Apyrr{ AorcyMeHTvr,
no4,po6Ho ortHCBaqH cneqra$:,z,Kara Ha rrpeAnaraHara araparypa.
O6epra 4: ex.Nq [0-07-04 Ha "I,IAAH - MEII4IfIZHCKA AIAPATYPA"
8"4C. Y.racrHLrK'bT "I4AAH - MEAIZUI4HCKA AIIAPATyPA" OOA, e rpHAo)Kr4A
Cnucrx Ha AorlyMeHTr4Te, cb.qbp>Kax1I4 ce B o$epraT a Ha Sr,rpvrara; AaHHH
3a Aaqero, Koero rtpaBr4 npeA o)KeHHe; fiexaapar\vrfl. orHocHo cepBn3Hara
6aza; fiexnapar{Hs c HMeHara Ha cepBa3Hrzre c[eqraalvrcrvr c rpr4lo)KeHr4
Aor(yMerTvr 3a o6yrenaero vru; flexnapar{Hs crrr4cbK Ha H3rrblHe:r^vr or
yr{acrHuKa AoroBopu, cxoAHH c npeAMera Ha [opbrrKara; PeSepeHqus 5
6p.; A4vtlaulrcrparkrBHvr cBeAeHHs; f,exnap ar1:z^fl. orHocHo Arzrrcara Ha
o6crogrencTBa uo .rn.55, atv.7 or 3OfI - 2 6p; flexnapar\vrfl. orHocHo Arzrcara
ua o6crosrelcTBa ro.rn.8, an.^.S, T.2 or 3OII - 2 6p.; Aexnapaqr4s no ua,.47,
arr.9 or 3OII - 2 6p.; flexzrapaqas uo vzr.56, al. 1, T.B or 3OII; .(exaapaqas,
o6paseq Nq10; Aexaapaqas, ee rpeA ox<eHHTe ypeArz ca Sa6pvrrrHo HoBrz,
rpor,r3BeAeHr4 He ro-paHo or 2OI4 r. 14 He ca peqlrK vrpaHvr; Texsu.recKa
oQepra; CeprraSurar ISO 13485:2003 Ha rzMero Ha rpoa3BoAprrel-s;
CeptuQuKar ISO 9001:2008 Ha )^{acrHvrKa; PaspeureHue 3a rtproBrzs Ha
eApo c MeATzqHHCKH v3pae^vrn per. NqIV-P-T lMVl -389 I 28.07 .2008 r. vr
PaspeureHrze 3a rpoMnHa NoIV-P-T IMI -572 I 14.06.2O1O; Ilpo4yxroBa
6pourypa c rpeBoA; f,exnap ar\vs. 3a ctorBercrBrze or rrpor43BoAraTel-fr
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wpaitu:,z,z cpoK 3a nolf{aBaHe Ha oQeprure. Cpoxm 3a H3rrblHe:r.vre Ha
U BbBe>KAaHe B eKCrIAOaTarlI4s, B TOBa r{IZCAO Vr
o6yreurae Ha rlepcoHala e 30 KaAeHAapHH AHV, cqrzraHo or Aarara Ha
/q,ocTaBKaTa, MoHTa)K6T
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cAeA AocraBKara. Ilper noBpeAa rs ule 6'a4e orcrpaHsBaHa B cpoK 10
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BKAIoqeHo B qeHara yrracrHvrK'br ule AocraBr4 rrocorreHrz B oQeprara My
BI4AOBe Vr KOAIZT-IeCTBa pe3epBHIZ IIpI4HaAAeX<HOCTII Vr KOHCyMaTVTBVT Ha
crofiuocr 3300.00 AB. 6es EAC.[p.q^araHr4Te MeAuqlz:acKvr anaparu
npuTe>KaBar rexHar{ecKIa cneqrzSvKar\krvr, KoHTo rroKpaBar Mr4Hr4MaAHr4Te
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EyACOKCHMeTpkrs., ily/\COBa KpkIBa, HeHHBa3HBHO apTepHaAHO Ha^-sra}Je VI ABe
TeAecHH TeMfrepaTypH.
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OTlOBaps Ha Iz3HCKBaIJvIflTa Ha Bb3AO>KvITeI\fl., AOilyCTHMo e vI J/aIaCTHkIKa
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MoHTax(br H BbBe>KAaHe B eKCrrAoararIHSI, B ToBa qr,rclo u o6yrenae Ha
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oTroBaps Ha H3HCKBanfVT,{Ta Ha Bb3AO)KVrTe/\fl., AOilyCTT4MO
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MoHTax(BT v BbBe>KAaHe B eKc[Aoaraqas, B ToBa qHCAo vr o6yuenue Ha
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Otrepra 4: ex.Nq ilO-07-04 Ha "I4AAH - MEAI4IIIZHCKA AIAPATYPA"
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AHV, CI{HTaHO OT KpairHVrs. CpOK 3a rro^yrraBaHe Ha Oseprate. cporm 3a
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24 tteceqa cAeA AocraBKara. IIpa iloBpeAa rs rqe 6r4e orcrpaHsBaHa B cpoK
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npaTe>KaBar rexHur{ecKz cuequ$vrKar\w, KoHTo rroKprzBar l.r,vrHvrv^alrHzTe
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ny^CoKcvrMeTpvrfl,, Kr,rc^opoAHa caTypar\wfl, TeAecHa TeM[epaTypa,
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cAeABa la 6:'.rye AonycHar Ao oqeHKa vr Kuacr4paHe.
CneA rrpeqeHKa Ha Ao[ycruMocrra Ha upeA oN(eHr.rsra, KoMrzcusTa
npr4cTGrrrz KBM oueHKa vr KAacupaHe:
..nbr{MEn ZHTEPHEIIAHbA" EOOA. rp. Co&Hg
Te>xecma Ha noKa3arel-s (Ull - rpeAnox<eHa or yLracrHnKa rleHa,
rz3qHCAeHa ilo MeroAaKara 3a oqeHKa na o$eprara e 37 r57 r.;
Te>r<ecr:ra Ha rroKa3arel.a lTI2l H3rrbAHeHHe HaA Mr4H . kr3r4cKBa:r-vrfl.
c,rrl. TexH. cneqa$wwan1uw, rz3r{HCAeHa rro noAnoKa3arelr4Te B Mero1nKara
II(2.1) - MonHTopHpaHe Ha relecHa reMileparypa lOoh; II(2.2)
MonuropupaHe Ha aprepr4alHo Hal.rrrare - 2Ooh; IIo II(2.3) - OcquloMerprzs
(nyncoea KprzBa) - 1Oo/o, e o6u{o - 16r.
Te>recma Ha roKa3aren-s (n3l - PesepBHr4 [pHHaAAe>KHocrr,r kI
KoHCyMarr4Bvr (crofinocrHo B AeBa 6es ftnC,) H3qr4cAeH no Mero,u,HKara 3a
oqeHKa na o$eprara - 9 r43 r.
Kouuaerrcga orLeHKa Ha upeA/\olxeHrrero Ha ysacrgurra e 63
TOIII(H.
,,MEIAMEA BbAlAPI,If" EOOA, rp. Co@ag:
Te>recma Ha rroKa3arels (n1) - rpeA o>KeHa or ) lacrHvrKa qeHa,
rz3r{r4cleHa rro MeroAzKara 3a oqeHKa na oSeprara - e 5Or.;
Tex<ecr-ra Ha rroKa3aren-s lII2l
rz3rrGAHeHHe HaA Mr4H . vr3vrcKBaHvrfl
c'brl. TexH. cneqa$uxaquu, H3t{HCAeHa rlo rroArloKa3arelaTe B Mero Ar4Kara:
II(2. 1) - Monr4TopapaHe Ha relecHa reMueparypa Oo/o; nQ2)
MosuropapaHe Ha aprepualHo Hal-srare - 2Ooh; IIo II(2.3) - OcquloMerpas
- L2r.
Te>xecr*ra Ha rloKa3aren-fl (fI3) - PesepBHr,r rrpHHaAAe)KHocrH vr
KoHCyMaruBvr (ctofinocrHo B AeBa 6es flflC,) H3r{HCAeH uo MeroAuKara 3a
or{eHKa na o$eprara - 4186r.
Kouuaexcua orr,euxa Ha rrpeA/\oxreguero Ha ysacrgrrr(a e 66186
(nyurcoea KpHBa) - 1Oo/o, e o6ulo
TOqITH.
..EAIIAK - ntr43tr4H1" EOOn, rparr BapHa:
Te>xecma Ha noKa3arel.rr (fll] - [peAAoN(eHa or yLracrHvrKa LleHa,
H3r{r4cneHa rro MeroAuKara 3a oqeHKa na oSeprara - e 34r73r.;
Te>r<ecma Ha roKa3arenfl lflzl
H3rrbAHeHHe HaA MHH. vrsr4cKBaunfl.
cbrl. TexH. crteqraSrarcaquu, H3rrHCAeHa rro [oArroKa3arenr4Te B MeroAr4Kara'.
II(2.1) - MonHTopHpaHe Ha relecHa reMneparypa Oo/o; nQ.2)
MonuropzpaHe Ha aprepualHo Hal-rrrare - 2Ooh; IIo II(2.3) - OcqraloMerpas
(uyncoea KpHBa) - 1Oo/o, e o6ulo - L2 r.;
Te>r<ecma Ha rroKa3arel-rr (fI3) - PesepBHH rprzHaAle)KHocru vL
KoHcyMarvrBvr (cTofinocrHo B AeBa 6es fl.[I,C,) H3r{HCAeH rro MeroAuKara 3a
oqeHKa na oSeprara - 3r79r.
Kouruaexcua orrerrxa Ha [peA oxreHrrero Ha yrracrurrxa e 5Or52
TOIIKII.
- MBTII4IfI4HCKA AIIAPATYPA" OOrl. rpaa Bapna:
Te>xecrta Ha rloKa3arel.s (fll] - upeA o)KeHa or ],^{acrHVKa I{eHa,
"I,IAAH
r43qr4cleHa rro MeroAr4Kara 3a oqeHKa na
o$eprara - e 34rO4r.;
H3rrbAHeHHe HaA MHH . v3r4cKBa:r.vrfl,
Te>xecma Ha rroKa3arel-rr lflzl
cGrA. TexH. crreqr,tSuxaqau, H3rrHCAeHa no [oAnoKa3arenr4Te B Mero AwKara.
II(2 . 1) - MonHTopHpaHe Ha relecHa reMueparypa lOo/o; I1(2 .2\
MosprroprzpaHe Ha aprepaalHo Hal-srare - 2Ooh; IIo II(2.3) - OcquloMerpus
(uyncoea KprzBa) - 1Oo/o, e o6u{o - 16 r.
Te>xec'r:ra Ha roKa3aren s (fI3) - PesepBHH npr4FraAle)KHocrrz u
KoHCyMarvBr4 (ctofinocrHo B AeBa 6es fl[C,) H3qHCAeH rto MeroArzKara 3a
oqeHKa na o$eprara - 1Or.
Kouuaer(cHa orr,eur(a Ha rrpeA/\oxreurrero Ha yqacrxrrxa e 60104
TOqITII.
C orne4 Ha ropHoro KoMHCr4sra rr3Bbprrrl{ Klacr4paHe Ha )aqacrHr4luzre,
KaKTo cAeABa: Ha rrtpBo Macro c 66186 Totrxu ,TMEIAMEA
E1bAfAPVIfl" EOOA, rp. Co$ua, E& Bropo Mscro c 63 To.rr(H e
,,A6[IMEA HHTEPHEIIIAHbA* EOOA, rp. CoQurr Ho rpero Macro c
60,04 Toslru e "HAAH MEAHIIHHCI(A AIAPATyPA" OOA, rpag
Bapna, Ha serBtpro Mscro c 50,52 To.rxrr ,TEAIIAK - AH3HHI" EOOA,
rpaA Baprra.
Pa6orata Ha KoMHCHflTa rpuKlror{rz Ha 26.11.2O 14r. e 14,00 qaca.
HacT ogrqu.ar [poroKon ce cbcraBr B eAuH eK3eMrtn-sp, xofiro 3aeAHo c
c LIsAara AoKyMeHTaqwa, cr6paHa B xoAa Ha rpoqeAypara ce rtpeACTaBH Ha
(flrapexrop na P3I,l
-p Arr6ena Aalu6eea)
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