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CAS Registry ! 25102-12-9. #G0A=8: ?>28=5= ?V4B25@48B8 <>6;82VABL ?>AB02:8 70?@>?>=>20=>3> =8< B>20@C, C =5>1EV4=V9 :V;L:>ABV B0 2V4?>2V4=>W O:>ABV, 287=0G5=V FVTN B5=45@=>N 4>:C<5=B0FVTN B0 ?@>?>78FVTN CG0A=8:0. 0 ?V4B25@465==O CG0A=8: ?>28=5= =040B8 >@83V=0; 30@0=BV9=>3> ;8AB0 28@>1=8:0 01> ?@54AB02=8:0, 48;5@0, 48AB@81'NB>@0 (C?>2=>2065=>3> =0 F5 28@>1=8:><, O:I> WE 2V4?>2V4=V ?>2=>2065==O ?>H8@NNBLAO =0 B5@8B>@VN #:@0W=8).  30@0=BV9=><C ;8ABV <0T 1CB8 707=0G5=0 V=D>@<0FVO ?@> =><5@ ID UA-& B5=45@C 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L, =072C ?@54<5B0 70:C?V2;V B0 =072C CG0A=8:0. 8@V1 ?>28=5= 2V4?>2V40B8 =0ABC?=8< =0FV>=0;L=8< AB0=40@B0<: !"# EN ISO 14971:2015; !"# EN 62366:2015; !"# EN ISO 10993-1:2015; !"# EN ISO 15223-1:2018.?0:100744206 - =0;V70B>@ 3;N:>78 IVD, ;01>@0B>@=89 02B><0B87>20=89@>1V@:0 4;O 3;N:>78 (AV@0): DB>@84 =0B@VN + 35?0@8= =0B@VN 13E75 <<,2<;1 T<: 2 <;. >7<V@8: 13E75 <<. $0AC20==O: 100 HB. 2 C?0:>2FV. >28==V 1CB8 ?@840B=V 4;O F5=B@8DC3C20==O ?@8 1100-1300 g. 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'8AB>B0 =0?>2=N20G0 ?>28==0 1CB8 1V;LH5 O: 99.0%. "8? =0?>2=N20G0 ?V4B25@465=89 CAS Registry Number. CAS Registry ! 65501-24-8. #G0A=8: ?>28=5= ?V4B25@48B8 <>6;82VABL ?>AB02:8 70?@>?>=>20=>3> =8< B>20@C, C =5>1EV4=V9 :V;L:>ABV B0 2V4?>2V4=>W O:>ABV, 287=0G5=V FVTN B5=45@=>N 4>:C<5=B0FVTN B0 ?@>?>78FVTN CG0A=8:0. 0 ?V4B25@465==O CG0A=8: ?>28=5= =040B8 >@83V=0; 30@0=BV9=>3> ;8AB0 28@>1=8:0 01> ?@54AB02=8:0, 48;5@0, 48AB@81'NB>@0 (C?>2=>2065=>3> =0 F5 28@>1=8:><, O:I> WE 2V4?>2V4=V ?>2=>2065==O ?>H8@NNBLAO =0 B5@8B>@VN #:@0W=8).  30@0=BV9=><C ;8ABV <0T 1CB8 707=0G5=0 V=D>@<0FVO ?@> =><5@ ID UA-& .B5=45@C 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L, =072C ?@54<5B0 70:C?V2;V B0 =072C CG0A=8:0. 8@V1 ?>28=5= 2V4?>2V40B8 =0ABC?=8< =0FV>=0;L=8< AB0=40@B0<: !"# EN ISO 14971:2015; !"# EN 62366:2015; !"# EN ISO 10993-1:2015; !"# EN ISO 15223-1:2018.?0:270947588-@>1V@:0 20:CC<=0 4;O 2V41>@C 7@07:V2 :@>2V IVD, 7 K3"@>1V@:0 4;O 701>@C :0?V;O@=>W :@>2V 0,5 <; 7 3 " 7 ?;0AB8:>2>N :@8H:>N.@>1V@:0 4;O FV;L=>W :@>2V (35<0B>;>3VO). @>1V@:8 ?>28==V 1CB8 AB01V;L=V 4> 707=0G5=>3> B5@<V=C ?@840B=>ABV 70 C<>28 715@V30==O ?@8 4...25C. 030;L=89 B5@<V= ?@840B=>ABV ?>28=5= AB0=>28B8 =5 <5=H5 O: 18 <VAOFV2. 0?>2=N20G: K3 " C10H13K3N2O82H2O. <VAB =0?>2=N20G0 ?>28=5= AB0=>28B8 1V;LH5 O: 99.0%. "8? =0?>2=N20G0 ?V4B25@465=89 CAS Registry Number. CAS Registry ! 65501-24-8. #G0A=8: ?>28=5= ?V4B25@48B8 <>6;82VABL ?>AB02:8 70?@>?>=>20=>3> =8< B>20@C, C =5>1EV4=V9 :V;L:>ABV B0 2V4?>2V4=>W O:>ABV, 287=0G5=V FVTN B5=45@=>N 4>:C<5=B0FVTN B0 ?@>?>78FVTN CG0A=8:0. 0 ?V4B25@465==O CG0A=8: ?>28=5= =040B8 >@83V=0; 30@0=BV9=>3> ;8AB0 28@>1=8:0 01> ?@54AB02=8:0, 48;5@0, 48AB@81'NB>@0 (C?>2=>2065=>3> =0 F5 28@>1=8:><, O:I> WE 2V4?>2V4=V ?>2=>2065==O ?>H8@NNBLAO =0 B5@8B>@VN #:@0W=8).  30@0=BV9=><C ;8ABV <0T 1CB8 707=0G5=0 V=D>@<0FVO ?@> =><5@ ID UA-& .B5=45@C 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L, =072C ?@54<5B0 70:C?V2;V B0 =072C CG0A=8:0. 8@V1 ?>28=5= 2V4?>2V40B8 =0ABC?=8< AB0=40@B0<: !"# EN ISO 14971:2015; !"# EN 62366:2015; !"# EN ISO 10993-1:2015; !"# EN ISO 15223-1:2018.?0:151031400 ->=B59=5@ 4;O 71>@C ?@>1 A5GV AB5@8;L=89 IVD<:VABL 4;O A5GV AB5@8;L=0 60<;  <:VABL 7 :@8H:>N ?@87=0G5=0 4;O 71>@C B0 715@V30==O 7@07:V2 A5GV. @8H:0 ?>28==0 70328=GC20B8AO B0 70157?5GC20B8 35@<5B8G=VABL 2<VABC. 0B5@V0;: T<:VABL  ?>;V<5@=89 <0B5@V0;, :@8H:0  ?>;V5B8;5= =87L:>3> B8A:C. 1 T<  60 <;. 0 T<:>ABV ?>28==> 1CB8 3@04CN20==O 4> 60 <;. 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"5<?5@0BC@0 715@V30==O: 4-25p !. 8@V1 ?>28=5= 2V4?>2V40B8 =0ABC?=8< =0FV>=0;L=8< AB0=40@B0<: !"# EN ISO 14971:2015; !"# EN 62366:2015; !"# EN ISO 10993-1:2015; !"# EN ISO 15223-1:2018. #G0A=8: ?>28=5= ?V4B25@48B8 <>6;82VABL ?>AB02:8 70?@>?>=>20=>3> =8< B>20@C, C =5>1EV4=V9 :V;L:>ABV B0 2V4?>2V4=>W O:>ABV, 287=0G5=V FVTN B5=45@=>N 4>:C<5=B0FVTN B0 ?@>?>78FVTN CG0A=8:0. 0 ?V4B25@465==O CG0A=8: ?>28=5= =040B8 >@83V=0; 30@0=BV9=>3> ;8AB0 28@>1=8:0 01> ?@54AB02=8:0, 48;5@0, 48AB@81'NB>@0 (C?>2=>2065=>3> =0 F5 28@>1=8:><, O:I> WE 2V4?>2V4=V ?>2=>2065==O ?>H8@NNBLAO =0 B5@8B>@VN #:@0W=8).  30@0=BV9=><C ;8ABV <0T 1CB8 707=0G5=0 V=D>@<0FVO ?@> =><5@ ID UA-& B5=45@C 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L, =072C ?@54<5B0 70:C?V2;V B0 =072C CG0A=8:0. #G0A=8: =040T 2 A:;04V 4>:C<5=BV2 B5=45@=>W ?@>?>78FVW 45:;0@0FVN B0/01> V=AB@C:FVN B0/01> A5@B8DV:0B O:>ABV B0/01> A5@B8DV:0B ISO (4>?CA:0TBLAO ?5@5:;04 =0 C:@0W=AL:C <>2C, O:I> 4>:C<5=B A:;045=89 =0 V=HV9 <>2V) 2 O:8E <VAB8BLAO V=D>@<0FVO ?@> E0@0:B5@8AB8:8 70?@>?>=>20=>3> CG0A=8:>< B>20@C.?0:11813732-V>;>3VG=89 V=48:0B>@ :>=B@>;N20==O AB5@8;V70FVWV>B5AB8 4;O 02B>:;02V2 =0 132!V>;>3VG=89 V=48:0B>@ T V=48:0B>@=8< :><?;5:B><, I> 2:;NG0T =0ABC?=V :><?>=5=B8: - B5AB>2C A<C6:C, O:0 <VAB8BL AC?5@5G:8 B5@<>DV;L=8E 10:B5@V9 Bacillus stearothermophilus (Geobacillus stearothermophilus)  "!! 7953, <V=V<0;L=>W :>=F5=B@0FVW 1,0105 #. 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XII. >40B:8 4> >3>2>@C 12.1. > FL>3> >3>2>@C 4>40NBLAO B0:V <0B5@V0;8, O:V T 9>3> =52V4 T<=>N G0AB8=>N. 12.2. !?5F8DV:0FVO ">20@C (4>40B>: 1). XIII. VAF57=0E>465==O B0 10=:V2AL:V @5:2V78B8 AB>@V= : !"',   !3 4@5A0: 03148, <. 8W2, C;. 0A8;O CG5@0, 7 UA__________________________  "  @820B10=: >4 10=:C ___________________  # 05496796  054967926576 !2. ! 36375548 B. (044)276-96-01 .>. 48@5:B>@0   !3 ______________ . ' <.?. >40B>: 1 4> 4>3>2>@C !___ 2V4 __ ____________ 2023 @. !?5F8DV:0FVO B>20@C ! 7/? 09<5=C20==O B>20@C @0W=0 28@>1=8:48=8FO 28<V@CV;L:VABL &V=0 70 >48=8FN (157 ), 3@=. &V=0 70 >48=8FN (7 ), 3@=!C<0 (7 ), 3@=.1234567812& 0@BVABL , 3@=.030;L=0 20@BVABL 7 , 3@=. : !"',:   !3 4@5A0: 03148, <. 8W2, C;. 0A8;O CG5@0, 7 UA___________________________  "  @820B10=: >4 10=:C _____________________  # 05496796  054967926576 !2. ! 36375548 B. (044)276-96-01 .>. 48@5:B>@0   !3 ______________ . 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