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"8? 7 T4=0==O Luer lock (C5@ ;>::) 01> Luer slip (C5@ A;V?). = T:FV9=0 <5B0;520 0B@02<0B8G=0 3>;:0 7 B@83@0==8< 703>AB@5==O<, <0T A8;V:>20=5 ?>:@8BBO 4;O ?>;53H5==O 22545==O, @>7<V@ =5 <5=H5 0,8 E 38<<. >;8:>289 @53C;OB>@ H284:>ABV ?>B>:C. 53C;OB>@ H284:>ABV ?>B>:C 10@010==>3> B8?C, 283>B>2;5=89 7 <548G=>3> ?>;V5B8;5=C. 2V H:0;8 @53C;N20==O H284:>ABV ?>B>:C - 2V4 0 4> 250 <;/ 3>4 4;O @>7G8=V2 7 =87L:>N 2 O7:VABN, - B0 2V4 0 4> 200 <;/3>4 4;O @>7G8=V2 7 28A>:>N 2 O7:VABN. ;0AB8G=89 ?5@5EV4=8: <V6 B@C1:>N B0 V= T:FV9=>N 3>;:>N 4;O 4>40B:>2>3> 22545==O ;V:0@AL:8E 70A>1V2. ;O >4=>@07>2>3> 28:>@8AB0==O. !B5@8;L=0, 0?V@>35==0 B0 =5B>:A8G=0. =482V4C0;L=0 C?0:>2:0. "5@<V= ?@840B=>ABV 3 @>:8 7 40B8 283>B>2;5==O, 2:070=>W =0 C?0:>2FV. !#/ 2V4?>2V40T <V6=0@>4=><C B0 AB0=40@BC #:@0W=8 ISO 13485. V4?>2V40T 28<>30< AB0=40@BC EN ISO 8536-4.HB10048(?@8F 2,0 <;47017 - (?@8F 7030;L=>3> ?@87=0G5==O @07>2>3> 70AB>AC20==O (?@8F >4=>@07>289 3-:><?>=5=B=89 2 <; 7 3>;:>N 0,6 E 25 << (23GE1'') ;O ?@>2545==O 2=CB@VH=L>25==8E B0/01> 2=CB@VH=><`O7>28E V= T:FV9. "@L>E:><?>=5=B=89. 1'T<>< 2,0 <;. @>7>@89 F8;V=4@, :0=N;O 3>;:8 7 :>2?0G:><, 283>B>2;5=V 7 3><>?>;V<5@0 ?>;V?@>?V;5=C. >@H5=L 7V HB>:><, 283>B>2;5=V 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. 'VB:0, ABV9:0 4> AB8@0==O H:0;0. !B>?>@=5 :V;LF5 (1;>:V2=8: ?>@H=O). C<>289 CIV;L=N20G 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. `T<=0 0B@02<0B8G=0 3>;:0 7 B@83@0==8< 703>AB@5==O< B0 :>2?0G:><. >;:0 7 0CAB5=VB=>W =5@602VNG>W AB0;V. >7<V@ 3>;:8 70 :0;V1@>< 23 G, 1 B0 <5B@8G=89 @>7<V@ 3>;:8 0,6 E 25<<. 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"5@<V= ?@840B=>ABV 5 @>:V2 7 40B8 283>B>2;5==O, 2:070=>W =0 C?0:>2FV. !B5@8;L=89, 0?V@>35==89, =5B>:A8G=89. =482V4C0;L=5 ?0:C20==O.HB5000050(?@8F 10,0 <;47017 - (?@8F 7030;L=>3> ?@87=0G5==O @07>2>3> 70AB>AC20==O (?@8F >4=>@07>289 3-:><?>=5=B=89 10 <; 7 3>;:>N 0,8 E 38 << (21GE1 1/2'') ;O ?@>2545==O 2=CB@VH=L>25==8E B0/01> 2=CB@VH=><`O7>28E V= T:FV9. "@L>E:><?>=5=B=89. 1'T< 10,0 <;. @>7>@89 F8;V=4@, :0=N;O 3>;:8 7 :>2?0G:><, 283>B>2;5=V 7 3><>?>;V<5@0 ?>;V?@>?V;5=C. >@H5=L 7V HB>:><, 283>B>2;5=V 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. 'VB:0, ABV9:0 4> AB8@0==O H:0;0. !B>?>@=5 :V;LF5 (1;>:V2=8: ?>@H=O). C<>289 CIV;L=N20G 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. `T<=0 0B@02<0B8G=0 3>;:0 7 B@83@0==8< 703>AB@5==O< B0 :>2?0G:><. >;:0 7 0CAB5=VB=>W =5@602VNG>W AB0;V. >7<V@ 3>;:8 70 :0;V1@>< 21 G, 1 1/2 B0 <5B@8G=89 @>7<V@ 3>;:8 0,8 E 38<<. "8? 7'T4=0==O C5@ A;V?. 5 <VAB8BL ;0B5:A. >25@E=O H?@8F0 G8AB0 B0 =5 <VAB8BL AB>@>==VE G0AB>:. 5@B289 ?@>ABV@ =5 1V;LH5 0,1 <;. <07:0 =5 ?><VB=0, :V;L:VABL =5 ?5@528ICT 0,25 <3/A<. !B5@8;L=89, =5B>:A8G=89 B0 0?V@>35==89. ;O >4=>@07>2>3> 28:>@8AB0==O. =482V4C0;L=5 ?0:C20==O 35@<5B8G=5 B0 FV;VA=5. V4?>2V40T 28<>30< ISO 7886-1, ISO 7864, ISO 80369-7. 83>B>2;5=89 73V4=> 28<>3 AB0=40@BC !"# ISO 13485.HB2000051(?@8F 20,0 <;47017 - (?@8F 7030;L=>3> ?@87=0G5==O @07>2>3> 70AB>AC20==O (?@8F V= T:FV9=89 >4=>@07>2>3> 28:>@8AB0==O, ;CT@ A;V?, 20,0 <; (B@L>E:><?>=5=B=89, 7 3>;:>N 0,8 E 38 <<) ;O ?@>2545==O ?V4H:V@=8E, 2=CB@VH=L>H:V@=8E, 2=CB@VH=L>25==8E B0/01> 2=CB@VH=L>< O7>28E V= T:FV9 2 <548F8=V, :>A<5B>;>3VW B0 25B5@8=0@VW. "@L>E:><?>=5=B=89. 1 T< B0 @>7<V@ 3>;:8 H?@8F0 20 <; - 0,8E38 << (21GE1 1/2''), CT@ !;V?. @>7>@89 F8;V=4@, :0=N;O 3>;:8 7 :>2?0G:>< 283>B>2;5==V 7 3><>?>;V<5@0 ?>;V?@>?V;5=C. 53:5 :>270==O ?>@H=O, 157 B5@BO, 4;O 1571>;VA=>W V='T:FVW. C<>289 CIV;L=N20G 7 A8=B5B8G=>3> <0B5@V0;C, I> =5 28:;8:0T 0;5@3VG=8E @50:FV9. C<>289 CIV;L=N20G A?5FV0;L=>W D>@<8 B0 7 ?>42V9=8<8 :V;LFO<8 4;O 70157?5G5==O <'O:>3> V ?;02=>3> 22545==O ;V:V2 B0 <0:A8<0;L=> 7=86CT 9<>2V@=VABL 70;8H:V2 ?@5?0@0BC 2 F8;V=4@V H?@8F0. !B>?>@=5 :V;LF5 <VF=5 B0 ?>42V9=5, 70?>1V30T 28?04:>2><C 28A:>270==N ?>@H=N ?@8 =01>@V ;V:0@AL:>3> 70A>1C. 'VB:0, ABV9:0 4> AB8@0==O H:0;0 4>72>;OT B>G=> 4>7C20B8 ?@5?0@0B. VB:8 =0 H:0;V >4=0:>2>W B>2I8=8 B0 @V2=><V@=> @>7?>4V;ONBLAO ?> F8;V=4@C. 1 T<, I> =5 28:>@8AB>2CTBLAO d" 0,15 <;. >=VG=89 =0:>=5G=8: <0T :>=CA 6% B0 2V4?>2V40T 28<>30< ISO 80369-7. V0<5B@ >B2>@C =0:>=5G=8:0 =5 <5=H5 1,2 <<. 0B5@V0; 283>B>2;5==O 3>;:8  0CAB5=VB=0 =5@602VNG0 AB0;L.  T<=0 0B@02<0B8G=0 3>;:0 7 :>2?0G:>< B0 B@83@0==8< 703>AB@5==O< 4;O 7<5=H5==O 1>;L>2>3> 2V4GCBBO B0 :><D>@BC ?0FVT=B0. 5 <VAB8BL ;0B5:A. V4?>2V40T 28<>30< AB0=40@BV2 ISO 7886-1, ISO 7864-1, ISO 9626, ISO 80368-7. 83>B>2;5=89 73V4=> 28<>3 AB0=40@BC !"# ISO 13485. 4=>@07>2>3> 70AB>AC20==O. "5@<V= ?@840B=>ABV 5 @>:V2 7 40B8 283>B>2;5==O, 2:070=>W =0 C?0:>2FV. !B5@8;L=89, 0?V@>35==89, =5B>:A8G=89. =482V4C0;L=5 ?0:C20==O.HB1500052(?@8F 100,0 <; 47017 - (?@8F 7030;L=>3> ?@87=0G5==O @07>2>3> 70AB>AC20==O (?@8F >4=>@07>2>3> 28:>@8AB0==O 100,0<; (:0B5B5@=89 B8?) ;O ?@><820==O 4@5=06V2 B0 22545==O ?>682=8E @5G>28= @V7=8E :>=A8AB5=FV9 01> ;V:0@AL:8E 70A>1V2 C :8H:>2>-H;C=:>289 B@0:B 2 <548F8=V B0 25B5@8=0@VW. "@8:><?>=5=B=89. 1'T< 100,0 <;. @>7>@89 F8;V=4@, 283>B>2;5=89 7 3><>?>;V<5@0 ?>;V?@>?V;5=C. >4>265=89 :>=CA 4;O ?V4 T4=0==O @V7=8E :>=5:B>@V2 :0B5B5@V2. 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