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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 April 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
1-amino-4-[(4-amino-2-sulfofenyl)amino]-9,10-dihydro-9,10-dioxo-2-anthracenesulfonic acid, disodium salt, reaction products with 2-[[3-[(4,6-dichloro-1,3,5-triazin-2-yl)ethylamino]phenyl]sulfonyl]ethyl hydrogen sulfate, sodium salts
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
reaction mass of: pentasodium; 2-[[8-[[4-chloro-6-[[4-(2-sulfonatethylsulfonyl)]phenyl]amino]-1,3,5-triazin-2-yl]amino-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]naphthalene-1,5-disulfonate; 2-[[8-[[4-chloro-6-[[4-[[2-ethenyl]sulfonyl]phenyl]amino]1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]naphthalene-1,5-disulfonate
450-010-8
-
Eye Dam. 1; Skin Sens. 1
2,2-diethoxy-N, N-dimethylacetamide
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
11-amino-3-chloro-6,11-dihydro-5,5-dioxo-6-methyl-dibenzo[c, f][1,2]thiazepine hydrochloride
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 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
reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy)but-2-ylamine
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
fatty acids, C18-unsatd., dimers, reaction products with 1-piperazineethanamine and tall oil
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
(R, S)-2-amino-3,3-dimethylbutane amide
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-ethyl-N-methyl-N-(3-methylphenyl)butanamide
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
methyl (9-acetoxy-3,8,10-triethyl-7,8,10-trimethyl-1,5-dioxa-9-aza-spiro[5.5]undec-3-yl)octadecanoate
445-990-9
376588-17-9
Skin Sens. 1
N, N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
trans-2-isopropyl-5-carboxy-1,3-dioxane
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
N, N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
(R, S)-1-[2-amino-1(4-methoxyphenyl)ethyl]cyclohexanol acetate
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3-chloro-4-(3-fluorobenzyloxy)aniline
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
reaction mass of: pentasodium; 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
2-methyl-5-tert-butylthiophenol
444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
chloro-1-ethylcyclohexyl carbonate
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one
444-860-9
474510-57-1
STOT RE 2
(2-butyl-5-nitrobenzofuran-3-yl)[4-(3-dibutylaminopropoxy)phenyl]methanone
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
(1R, 4R)-4-methoxy-2,2,7,7-tetramethyltricyclo(6.2.1.0(1,6))undec-5-ene
444-480-3
393517-29-8
Skin Irrit. 2
tetrabutyl-phosphonium nonafluoro-butane-1-sulfonate
444-440-5
220689-12-3
Acute Tox. 4
(3S, 6R, 9S, 12R, 15S, 18R, 21S,24R)-6,18-dibenzyl-3,9,15,21-tetraisobutyl-4,10,12,16,22,24-hexamethyl-1,7,13,19-tetraoxa-4,10,16,22-tetraazacyclo-tetracosane-2,5,8,11,14,17,20,23-octaone
444-350-6
133413-70-4
Eye Irrit. 2
(R)-1-cyclohexa-1,4-dienyl-1-methoxycarbonyl-methylammoniumchloride
444-320-2
-
Acute Tox. 4
reaction mass of: pentasodium bis[6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III); tetrasodium [6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato][6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III); trisodium bis[6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III)
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
2,6-bis(2,3,4-trihydroxybenzyl)-p-cresol ester with 6-diazo-5,6-dihydro-5-oxo-1-naphthalenesulfonate
444-250-2
144111-81-9
Self-react. C
reaction mass of: trisodium 5-{4-chloro-6-[N-ethyl-(3-(2-sulfonatooxy)ethylsulfonyl)aniline]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[4-(vinylsulfonyl)phenylazo{naphthalene-2,7-disulfonate; trisodium 5-4-chloro-6-[N-ethyl-3-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; disodium 5-4-chloro-6-[N-ethyl-3-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[(4-vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium 5-4-chloro-6-[N-ethyl-3-(2-(sulfonatooxy)ethylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-3-[4(2-(sulfonatooxy)ethylsulfonyl)phenylazo]-4-hydroxynaphthalene-2,7-disulfonate
444-050-5
-
Eye Dam. 1
2-(5,5-dimethyl-2,4-dioxooxazolidin-3-yl)-4,4-dimethyl-3-oxo-N-(2-methoxy-5-octadecanoylaminophenyl)pentanoic acid amide
443-980-9
221215-20-9
Skin Sens. 1
ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
(2,3,5,6-tetrafluorophenyl)methanol
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
(2S)-5-(benzyloxy)-2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)-5-oxopentanoic acid
443-560-5
88784-33-2
Eye Irrit. 2
trans-methyl-2-ethyl-but-2-enoate
443-150-6
101226-85-1
Flam. Liq. 3
methyl 2-chlorosulfonyl-4-(methanesulfonylaminomethyl) benzoate
443-120-2
393509-79-0
Eye Dam. 1
triphenyl(phenylmethyl)phosphonium 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1)
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
methyl 2-(acetylamino)-3-chloropropionate
442-860-3
87333-22-0
Skin Sens. 1
1,1-dimethylethyl 4'-(bromomethyl)biphenyl-2-carboxylate
442-850-9
114772-40-6
Skin Sens. 1
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
reaction mass of: 2-{3,6-bis-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl[}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,3-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,4-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,4-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,5-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2,4-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,4-dimethylphenyl)-methylamino]-6-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %)
442-800-6
-
Skin Irrit. 2
cobalt lithium nickel oxide
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
reaction mass of: 1,2-dimethylpropylidene dihydroperoxide; dimethyl 1,2-benzenedicarboxylate
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction mass of: 2-(2-((oxo(phenyl)acetyl)oxy)ethoxy)ethyl oxo(phenyl)acetate; (2-(2-hydroxyethoxy)ethyl)oxo(phenyl)acetate
442-300-8
-
Skin Sens. 1
reaction mass of: 3-[5-(4-ethenesulfonylbutyrylamino)-2-sulfophenylazo]-5-4-chloro-[6-(4-(3-amino-5-hydroxy-2,7-disulfonaphthalene-4-ylazo)-3-sulfophenylamino]-1,3,5-triazin-2-ylamino)-4-hydroxynaphthalene-2,7-disulfonic acid, sodium salt; 3-[5-(4-(2-chloroethanesulfonyl)butyrylamino)-2-sulfophenylazo]-5-4-chloro-[6-(4-(3-amino-5-hydroxy-2,7-disulfonaphthalene-4-ylazo)-3-sulfophenylamino]-1,3,5-triazin-2-ylamino)-4-hydroxynaphthalene-2,7-disulfonic acid, sodium salt
442-290-5
457624-86-1
Eye Dam. 1
2-{4-[4-[4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino]phenylazophenylazo}naphthalene-4,6,8-trisulfonate, trisodium salt
442-230-8
321679-52-1
Eye Dam. 1
pentasodium N-[5-[[4-[[3-[(aminocarbonyl)amino]-4-[(3,6,8-trisulfonatonaphthalen-2-yl)azo]phenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-2-sulfonato-4-[[4-[[-2-(oxysulfonato)ethyl] sulfonyl]phenyl]azo]phenyl]-3-aminopropanoic acid
442-030-0
321912-47-4
Eye Dam. 1
3,4-dihydroxy-5-nitrobenzaldehyde
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
6,6'-bis(diazo-5,5', 6,6'-tetrahydro-5,5'-dioxo)[methylene-bis(5-(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulphonyloxy)-6-methyl-2-phenylene]di(naphthalene-1-sulfonate)
441-550-5
-
Self-react. C; Carc. 2
3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)aniline
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
(S)-α-hydroxy-3-phenoxy-benzeneacetonitrile
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
ammonium 2-cocoyloxyethanesulfonate
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
1-ethoxy-2,3-difluorobenzene
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
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