EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 10 May 2024. Database contains 4753 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
dodecyl methacrylate
205-570-6
142-90-5
STOT SE 3
4-(5-(5-[1-(4-carboxyphenyl)hexahydro-2,4,6-trioxopyrimidin-5-ylidene]penta-1,3-dienyl)-1,2,3,4-tetrahydro-6-hydroxy-2,4-dioxopyrimidin-1-yl)benzoic acid-triethylamine salt
426-900-7
203118-12-1
STOT SE 3
tricresyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-); tritolyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-);tricresyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-); tritolyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-)
215-548-8
1330-78-5
STOT SE 1
mipafox (ISO); N,N'-di-isopropylphosphorodiamidic fluoride
206-742-3
371-86-8
STOT SE 1
tribenuron-methyl (ISO); 2-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid methyl ester; methyl 2-(3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3methylureidosulfonyl)benzoate
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
reaction mass of 7-[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(4-phenylazophenylazo)-naphthalene-2-sulfonate, acetic acid, lactic acid (2:1:1)
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
N, N-dimethyl-2-(3-(4-chloro phenyl)-4,5-dihydropyrazol-1- ylphenylsulphonyl)ethylamine
HOSTALUX VP 3481
401-410-6
10357-99-0
STOT RE 2; Skin Sens. 1
fenoxaprop-P-ethyl (ISO); ethyl (2R)-2-{4-[(6-chloro-1,3-benzoxazol-2-yl)oxy]phenoxy}propanoate
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
ethyl (1S, 5R, 6S)-5-(1-ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylate
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
carboxin (ISO); 2-methyl-N-phenyl-5,6-dihydro-1,4-oxathiine-3-carboxamide; 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide
226-031-1
5234-68-4
STOT RE 2; Skin Sens. 1
bromobenzylbromotoluene, reaction mass of isomers
DBBT
402-210-1
99688-47-8
STOT RE 2; Skin Sens. 1
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
atrazine (ISO);2-chloro-4-ethylamine-6- isopropylamine-1,3,5-triazine
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
4-(2-cyano-3-phenylamino acryloyloxymethyl)-cyclohexyl-methyl 2-cyano-3-phenylamino)-acrylate
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
2-naphthylamino-6-sulfomethylamide
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
2-chloro-4-fluoro-5-nitrophenyl(isobutyl)carbonate
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-butanone-O, O',O''-(phenylsilylidyne)trioxime
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
2-((4-(ethyl-(2-hydroxyethyl)amino)-2-methylphenyl)azo)-6-methoxy-3-methyl-benzothiazolium methylsulfate
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
2,7,11-trimethyl-13-(2,6,6-trimethylcyclohex-1-en-1-yl)tridecahexaen-2,4,6,8,10,12-al
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
(2,4-diaminopteridin-6-yl)methanol hydrobromide
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
2-n-hexadecylhydroquinone
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
2-(decylthio)ethylammonium chloride
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1
4-(3,4-dichlorophenylazo)-2,6-di-sec-butyl-phenol
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
methyl 3-isocyanatosulfonyl-2-thiophene-carboxylate
F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
diphenyl ether, pentabromo derivative pentabromodiphenyl ether
251-084-2
32534-81-9
STOT RE 2; Lact.
4-(4-nitrophenylazo)-2,6-di-sec-butyl-phenol
MORTRACE SB CONC.
410-610-2
111850-24-9
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
3-tridecyloxy-propyl-ammonium 9-octadecenoate
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
potassium N-(4-fluorophenyl)glycinate
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
dibutyl-3-(4-(5-ammonio-2-butyl)benzofuran-3-yl)carbonyl)phenoxy)propyl ammonium oxalate; (5-amino-2-butylbenzofuran-3-yl) [4-(3-dibutylaminopropoxy)phenyl]methanone, dioxalate
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
2,5-dioxopyrrolidin-1-yl N-{[methyl[[2-(1-methylethyl)-4-thiazoly]methyl]amino]carbonyl}-L-Valinate
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
(2R,3S)-N-(3-amino-2-hydroxy-4-phenylbutyl)-N-isobutyl-4-nitrobenzenesulfonamide hydrochloride
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
((4-phenylbutyl)hydroxyphosphoryl)acetic acid
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
bis-(6-hydroxy-4-methyl-5-(3-methylimidazolium-1-yl)-3-(4-phenylazo)-1H-pyridin-2-one)ethylene dilactate
421-560-6
-
STOT RE 2; Eye Dam. 1
2S-isopropyl-5R-methyl-1R-cyclohexyl 2,2-dihydroxyacetate
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
tetradecylammonium bis(1-(5-chloro-2-oxidophenylazo)-2-naphtholato)chromate(1-)
KAYASET BLACK T-2
405-110-6
88377-66-6
STOT RE 2
silthiofam (ISO); N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide
605-752-9
175217-20-6
STOT RE 2
reaction mass of:[2-(anthraquinon-1-ylamino)-6-[(5-benzoylamino)-anthraquinone-1-ylamino]-4-phenyl]-1,3,5-triazine; 2,6-bis-[(5-benzoylamino)-anthraquinon-1-ylamino]-4-phenyl-1,3,5-triazine.
ORANGE LEP 2471
421-290-9
-
STOT RE 2
reaction mass of: potassium N-[3-(dimethyloxidoamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane sulfonamidate; N-[3-(dimethyloxidoamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane; sulfonamide
422-500-1
-
STOT RE 2
reaction mass of: O, O',O''-(methylsilanetriyl)tris(4-methyl-2-pentanone oxime) (3 stereoisomers)
423-580-0
-
STOT RE 2
reaction mass of: N-(3-dimethylamino-4-methyl-phenyl)-benzamide; N-(3-dimethylamino-2-methyl-phenyl)-benzamide; N-(3-dimethylamino-3-methyl-phenyl)-benzamide
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
-
STOT RE 2
reaction mass of: bis[(2-ethyl-1-oxohexyl)oxy]dioctyl stannane; bis[((2-ethyl-1-oxohexyl)oxy)dioctylstannyl]oxide; bis(1-phenyl-1,3-decanedionyl)dioctyl stannane; ((2-ethyl-1-oxohexyl)oxy)-(1-phenyl-1,3-decanedionyl)dioctyl stannane
422-920-5
-
STOT RE 2
reaction mass of: 5-(N-methylperfluorooctylsulfonamido)methyl-3-octadecyl-1,3-oxazolidin-2-one; 5-(N-methylperfluoroheptylsulfonamido)methyl-3-octadecyl-1,3-oxazolidin-2-one
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
reaction mass of: 3-(N-(3-dimethylaminopropyl)-(C4-8)perfluoroalkylsulfonamido)propionic acid; N-[dimethyl-3-(C4-8-perfluoroalkylsulfonamido)propylammonium propionate; 3-(N-(3-dimethyl-propylammonium)-(C4-8)perfluoroalkylsulfonamido)propionic acid propionate
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
reaction mass of: 2,2'-[[cis-1,2-cyclohexanediylbis(nitrilomethylidene)]bis[phenolate]](2-)N, N',O, O'-copper complex;2,2'-[[trans-1,2-cyclohexanediylbis(nitrilomethylidyne)]bis[phenolate]](2-)N, N',O, O'-copper complex
419-610-7
171866-24-3
STOT RE 2
Reaction mass of: 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-tridecafluorooctyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-heptdecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-pentacosafluorotetradecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl)-12-(1''H,1''H,2''H,2''H-heptadecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl)-12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate
HFR-990
423-180-6
-
STOT RE 2
polychlorobiphenyls; PCB
215-648-1
1336-36-3
STOT RE 2
oxasulfuron (ISO); oxetan-3-yl 2-[(4,6-dimethylpyrimidin-2-yl)-carbamoylsulfamoyl]benzoate
604-430-5
144651-06-9
STOT RE 2
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