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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 30 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-[3-[4-((heptadecafluorononyl)oxy)-benzamido]propyl]-N, N,N-trimethylammonium iodide
FT-310; PF-310
407-400-8
59493-72-0
Eye Dam. 1
2-(2-(2-hydroxyethoxy)ethyl)-2-aza-bicyclo[2.2.1]heptane
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
sodium ((N-(3-trimethylammoniopropyl)sulfamoyl)methylsulfonatophthalocyaninato)copper(II)
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
tetrahydrothiopyran-3-carboxaldehyde
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
reaction mass of: ammonium-1,2-bis(hexyloxycarbonyl)ethanesulfonate; ammonium-1-hexyloxycarbonyl-2-octyloxycarbonylethanesulfonate; ammonium-2-hexyloxycarbonyl-1-octyloxycarbonylethanesulfonate
AMMONIUM DIAS
407-320-3
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: 1-deoxy-1-[methyl-(1-oxododecyl)amino]-D-glucitol; 1-deoxy-1-[methyl-(1-oxotetradecyl)amino]-D-glucitol (3:1)
GA1270; HOE S 4096
407-290-1
-
Eye Dam. 1
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(-3-(diethylammonio)propylamino)1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3, N4-η:N3', N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)
BLUE GS 1259 R5
407-230-4
126637-70-5
Acute Tox. 4; Skin Sens. 1
dichloro-(3-(3-chloro-4-fluorophenyl)propyl)methylsilane
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
2,3,4-trifluoroaniline
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
divanadyl pyrophosphate
BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
407-130-0
65232-89-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
trisodium (1-(3-carboxylato-2-oxido-5-sulfonatophenylazo)-5-hydroxy-7-sulfonatonaphthalen-2-amido)nickel(II)
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
reaction mass of: sodium/potassium (3-(4-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-methoxy-3-sulfonatophenylazo)-2-oxidophenylazo)-2,5,7-trisulfonato-4-naphtholato)copper(II); sodium/potassium (3-(4-(5-(5-chloro-4,6-difluoropyrimidin-2-ylamino)-2-methoxy-3-sulfonatophenylazo)-2-oxidophenylazo)-2,5,7-trisulfonato-4-naphtholato)copper(II)
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
N-(2-(6-ethyl-7-(4-methylphenoxy)-1H-pyrazolo[1,5-b][1,2,4]triazol-2-yl)propyl)-2-octadecyloxybenzamide
UM-229
407-070-5
142859-67-4
Skin Sens. 1
7-[((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-(4-((2-sulfoxy)ethyl)sulfonyl)phenylazo]naphthalene-2-sulfonic acid
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
2-bromo-2-nitropropanol
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
4-[N-ethyl-N-(2-hydroxyethyl)amino]-1-(2-hydroxyethyl)amino-2-nitrobenzene, monohydrochloride
NITROBLAU; NITROBLUE
407-020-2
132885-85-9
Acute Tox. 4; Skin Sens. 1
2,4-bis[2,2'-[2-(N, N-dimethylamino)ethyloxycarbonyl]phenylazo]-1,3-dihydroxybenzene, dihydrochloride
BASISCH GELB 8511
407-010-8
118208-02-9
Acute Tox. 4; Eye Dam. 1
2-isopropyl-2-(1-methylbutyl)-1,3-dimethoxypropane
406-970-5
129228-11-1
Skin Irrit. 2
9,9-bis(4-hydroxyphenyl)fluorene
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
reaction mass of: butan-2-one oxime; syn-O,O'-di(butan-2-one oxime)diethoxysilane
DOW CORNING (R) 4-2920 INTERMEDIATE
406-930-7
96-29-7
STOT RE 1; Skin Sens. 1
reaction mass of: bis(tris(2-(2-hydroxy(1-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate; bis(tris(2-(2-hydroxy(2-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
reaction mass of: hydroxyaluminium bis[2-hydroxy-3,5-di-tert-butylbenzoate]; 3,5-di-tert-butyl-salicylic acid
BONTRON E-88
406-890-0
130296-87-6
Acute Tox. 4
reaction mass of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
epoxiconazole (ISO); (2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane
406-850-2
133855-98-8
Carc. 2; Repr. 1B
trisodium 1-hydroxynaphthalene-2-azo-4'(5',5''-dimethylbiphenyl)-4''-azo(4''-phenylsulfonyloxybenzene)-2',2'',4-trisulfonate
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
4-propylcyclohexanone
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
(9S)-9-amino-9-deoxyerythromycin
E.M.A.
406-790-7
26116-56-3
Eye Dam. 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
2,3,4,5-tetrachlorobenzoylchloride
2,3,4,5-TETRACHLORBENZOYLCHLORID
406-760-3
42221-52-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3'-trifluoromethylisobutyranilide
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
4-(trans-4-propylcyclohexyl)acetophenone
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
Skin Sens. 1
6-(nonylamino)-6-oxo-peroxyhexanoic acid
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
potassium N-(4-toluenesulfonyl)-4-toluenesulfonamide
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
reaction mass of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N, N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N, N-di(C18)alkylacetamide
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
1-allyl-3-chloro-4-fluorobenzene
CFA; HOE 108219
406-630-6
121626-73-1
Skin Irrit. 2
reaction products of: aniline-terephthalaldehyde-o-toluidine condensate with maleic anhydride
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
N, N-diethyl-N',N'-dimethylpropan-1,3-diyl-diamine
DDPD
406-610-7
62478-82-4
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
ethyl-2-chloro-2,2-diphenylacetate
MCDPAE
406-580-5
52460-86-3
Skin Irrit. 2
4-methyl-8-methylenetricyclo[3.3.1.13,7]dec-2-yl acetate
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
reaction mass of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene (1:2:1)
MDI
406-550-1
-
Skin Sens. 1
2-chloro-4-(methylsulfonyl)benzoic acid
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
potassium 4-(11-methacrylamidoundecanamido)benzenesulfonate
V67282
406-500-9
174393-75-0
Skin Sens. 1
2-n-hexadecylhydroquinone
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.1 3,7]decan-2-ol
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
reaction mass of isomers of: α-((dimethyl)biphenyl)-ω-hydroxypoly(oxyethylene)
EMULGATOR SWA; EMULVIN SWA
406-325-8
-
Acute Tox. 4
4-[(3-hydroxypropyl)amino]-3-nitrophenol
PLAKATROT Z; ROT BN
406-305-9
92952-81-3
Skin Irrit. 2
vanadyl pyrophosphate
BTN; VPO CATALYST
406-260-5
58834-75-6
Eye Irrit. 2; Skin Sens. 1
methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
HALOXYFOP R-(+)-ME HERBICIDAL CHEMICAL
406-250-0
72619-32-0
Acute Tox. 4
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