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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 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
reaction mass of: 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonic acid; sodium 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonate; potassium 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonate
INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1
N,N,N',N'-tetraglycidyl-4,4'-diamino-3,3'-diethyldiphenylmethane
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
2-amino-4-chloro-6-methoxypyrimidine
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
2-(4-tert-butylphenyl)ethanol
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
3-((2-nitro-4-(trifluoromethyl)phenyl)amino)propane-1,2-diol
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
reaction products of tungsten hexachloride with 2-methylpropan-2-ol, nonylphenol and pentane-2,4-dione
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction mass of: 3-[(4-amino-2-chloro-5-nitrophenyl)amino]-propane-1,2-diol; 3,3'-(2-chloro-5-nitro-1,4-phenylenediimino)bis(propan-1,2-diol)
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
-
Acute Tox. 4
tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
di-n-octylaluminium iodide
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
D, L-(N,N-diethyl-2-hydroxy-2-phenylacetamide)
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
2-((4-methyl-2-nitrophenyl)amino)ethanol
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
3-(2-ethylhexyloxy)propane-1,2-diol
2-EHOPD; EHOPD; GE-EH; SENSIVA SC 50
408-080-2
70445-33-9
Eye Dam. 1
(2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
E-ethyl-4-oxo-4-phenylcrotonate
BAE; BENZOYLACRYLATE D'ETHYLE; BENZOYLACRYLATE D'ÉTHYLE (TRANS); BENZOYLACRYLIC ACID ETHYL ESTER; BENZOYLACRYLSÄURE ETHYLESTER
408-040-4
15121-89-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,2,6,6-tetrakis(bromomethyl)-4-oxaheptane-1,7-diol
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
2-(3-iodoprop-2-yn-1-yloxy)ethyl phenylcarbamate
SIS 46 305
408-010-0
88558-41-2
Acute Tox. 4; Eye Dam. 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
3,5-bis-(tetradecyloxycarbonyl)benzenesulfinic acid
AF-389
407-990-7
141915-64-2
Skin Sens. 1
etofenprox (ISO); 2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether
ETHOFENPROX; TREBON
407-980-2
80844-07-1
Lact.
N-butyl-3-(2-chloro-4-nitrophenylhydrazono)-1-cyano-2-methylprop-1-ene-1,3-dicarboximide
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
(R)-2-(4-hydroxyphenoxy)propanoic acid
D-HPPA; HPOPS
407-960-3
94050-90-5
Eye Dam. 1
bis(4-methylbenzoyl)peroxide
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
4-[2-(1-methyl-2-(4-morpholinyl)ethoxy)ethyl]morpholine
M.E.M.P.E.
407-940-4
111681-72-2
Eye Dam. 1
(η-cumene)-(η-cyclopentadienyl)iron(II) trifluoromethane-sulfonate
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
2-benzyl-2-methyl-3-butenitrile
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
2-(2,4-dichlorophenyl)-1-(1H—1,2,4-triazol-1-yl)pent-4-en-2-ol
TAA
407-850-5
89544-40-1
Acute Tox. 4; Eye Dam. 1
(η-cumene)-(η-cyclopentadienyl)iron(II) hexafluoroantimonate
CG 24-020; FERROCEN-SBF6
407-840-0
100011-37-8
Acute Tox. 4; Eye Dam. 1
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
sodium 4-(4-chloro-6-(N-ethylanilino)-1,3,5-triazin-2-ylamino)-2-(1-(2-chlorophenyl)-5-hydroxy-3-methyl-1H-pyrazol-4-ylazo)benzenesulfonate
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
N-ethyl-N-methylpiperidinium iodide
CATALYST 4017
407-780-5
4186-71-4
Acute Tox. 4
2-methylpropyl (R)-2-hydroxypropanoate
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 2
tetraconazole (ISO); (±) 2-(2,4-dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether
TETRACONAZOLE
407-760-6
112281-77-3
Acute Tox. 4
2-chloro-5-sec-hexadecylhydroquinone
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
reaction mass of: 2-chloro-5-sec-tetradecylhydroquinones where sec-tetradecyl = 1-methyltridecyl; 1-ethyldodecyl; 1-propylundecyl; 1-butyldecyl; 1-pentylnonyl; 1-hexyloctyl
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
N-butyl-2-(4-morpholinylcarbonyl)benzamide
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
sodium 3,5-bis(tetradecyloxycarbonyl)benzenesulfinate
AF-390
407-720-8
155160-86-4
Skin Sens. 1
reaction mass of compounds from (dodecakis(p-tolylthio)phthalocyaninato)copper(II)to (hexadecakis(p-tolylthio)phthalocyaninato)copper(II)
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
4,4-dimethoxybutylamine
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-[[4[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazine-2-yl]amino]phenyl]azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutanamide
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1
reaction mass of: diastereoisomers of 1-(1-hydroxyethyl)-4-(1-methylethyl)cyclohexane
MUGETANOL
407-640-3
63767-86-2
Eye Irrit. 2; Skin Irrit. 2
2,3,5,6-tetrahydro-2-methyl-2H-cyclopenta[d]-1,2-thiazol-3-one
CIN 10096132; MTI
407-630-9
82633-79-2
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
tert-butyl (5S,6R,7R)-3-bromomethyl-5,8-dioxo-7-(2-(2-phenylacetamido)-5-thia-1-azabicyclo[4.2.0] oct-2-ene-2-carboxylate
3-BMC
407-620-4
33610-13-8
Resp. Sens. 1; Skin Sens. 1
4'-ethoxy-2-benzimidazoleanilide
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
4,4'-diamino-2-methylazobenzene
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
trisodium(2-(α-(3-(4-chloro-6-(2-(2-(vinylsulfonyl)ethoxy)ethylamino)-1,3,5-triazin-2-ylamino)-2-oxido-5-sulfonatophenylazo)benzylidenehydrazino)-4-sulfonatobenzoato)copper(II)
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
reaction mass of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
FRUITATE
407-520-0
80657-64-3
Skin Irrit. 2
4'-fluoro-2,2-dimethoxyacetophenone
DMA
407-500-1
21983-80-2
Skin Sens. 1
reaction mass of: di-(1-octane-N, N,N-trimethylammonium) octylphosphate; 1-octane-N, N,N-trimethylammonium di-octylphosphate; 1-octane-N, N,N-trimethylammonium octylphosphate
NEWLON AM-92I
407-490-9
-
Acute Tox. 4; Skin Corr. 1B
2-hydroxyethylammonium perbromide
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
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