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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
4,4'-carbonimidoylbis[N, N-dimethylaniline]
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
salts of 4,4'-carbonimidoylbis[N, N-dimethylaniline]
show/hide
4,4'-carbonimidoylbis[N,N-dimethylaniline] acetate EC / List no: 225-801-4 | CAS no: 5089-20-3
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, (2-methoxyethoxy)acetate EC / List no: - | CAS no: 82941-28-4
4,4'-carbonimidoylbis[N,N-dimethylaniline] nitrate EC / List no: 282-561-3 | CAS no: 84255-15-2
Decyl hydrogen sulphate, compound with 4,4'-carbonimidoylbis[N,N-dimethylaniline] (1:1) EC / List no: 281-828-1 | CAS no: 84030-53-5
Benzenesulfonic acid, 4-dodecyl-, compd. with 4,4'-carbonimidoylbis(N,N-dimethylbenzenamine) (1:1) EC / List no: - | CAS no: 63589-43-5
Methanaminium, N-(4-(amino(4-(dimethylamino)phenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-methyl-, dodecyl(sulfophenoxy)benzenesulfonate (2:1) EC / List no: - | CAS no: 63428-09-1
4,4'-carbonimidoylbis[N,N-dimethylanilinium] sulphate EC / List no: 282-562-9 | CAS no: 84255-16-3
4,4'-carbonimidoylbis(N,N-dimethylaniline) monohydrochloride EC / List no: 219-567-2 | CAS no: 2465-27-2
4,4'-bis[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo][1,1'-biphenyl]-2,2'-disulphonic acid, compound with 4,4'-carbonimidoylbis[N,N-dimethylphenylamine] (1:2) EC / List no: 277-106-0 | CAS no: 72939-51-6
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, 2-hydroxyethanesulfonate EC / List no: - | CAS no: 86157-51-9
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, mono(dodecylbenzenesulfonate) EC / List no: - | CAS no: 82794-01-2
-
-
Carc. 2; Acute Tox. 4; Eye Irrit. 2
trisodium nitrilotriacetate
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
3,5,5-trimethylcyclohex-2-enone; isophorone
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
diethylcarbamoyl chloride
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,4,6-trichlorophenol
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
folpet (ISO);N-(trichloromethylthio)phthalimide
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea
206-354-4
330-54-1
Carc. 2; Acute Tox. 4; STOT RE 2
2,2'-methylenediphenyl diisocyanate; diphenylmethane-2,2'-diisocyanate
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4,4'-methylenediphenyl diisocyanate; diphenylmethane-4,4'-diisocyanate
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
methylenediphenyl diisocyanate
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
o-(p-isocyanatobenzyl)phenyl isocyanate; diphenylmethane-2,4'-diisocyanate
227-534-9
5873-54-1
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
1-vinyl-2-pyrrolidone
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
UVCB condensation product of: tetrakis-hydroxymethylphosphonium chloride, urea and distilled hydrogenated C16-18 tallow alkylamine
ITC 826 CONCENTRATE
422-720-8
166242-53-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
fuberidazole (ISO);2-(2-furyl-)-1H-benzimidazole
223-404-0
3878-19-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
imiprothrin (ISO); reaction mass of: [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-trans-chrysanthemate
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
tetramethrin (ISO); (1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
231-711-6
7696-12-0
Carc. 2; Acute Tox. 4; STOT SE 2
2,6-xylidine; 2,6-dimethylaniline
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
reaction products of diisopropanolamine with formaldehyde (1:4)
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
tributyl phosphate
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
N, N-dimethylanilinium tetrakis(pentafluorophenyl)borate
B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM
422-050-6
118612-00-3
Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
alachlor (ISO); 2-chloro-2',6'-diethyl-N-(methoxymethyl)acetanilide
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
etridiazole (ISO); 5-ethoxy-3-trichloromethyl-1,2,4-thiadiazole
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
(4-phenylbutyl)phosphinic acid
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
1,4-dichlorobenzene; p-dichlorobenzene
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
amisulbrom (ISO); 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
molybdenum trioxide
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
3-(4-chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
morpholine-4-carbonyl chloride
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
N-2-naphthylaniline; N-phenyl-2-naphthylamine
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
leucomalachite green; N, N,N',N'-tetramethyl-4,4'-benzylidenedianiline
204-961-9
129-73-7
Carc. 2; Muta. 2
o-phenylenediamine
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
o-phenylenediamine dihydrochloride
210-418-7
615-28-1
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Aniline
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
salts of aniline
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Anilinium p-tolylsulphonate EC / List no: 237-870-8 | CAS no: 14034-57-2
Anilinium chloride EC / List no: 205-519-8 | CAS no: 142-04-1
Benzenesulfonic acid, 2(or 4)-methyl-, compd. with benzenamine (1:1) EC / List no: - | CAS no: 70788-38-4
Anilinium dihydrogen phosphate EC / List no: 253-680-8 | CAS no: 37832-42-1
Phthalic acid, compound with aniline (1:1) EC / List no: 256-856-2 | CAS no: 50930-79-5
Benzenesulfonic acid, 2,2'-dithiobis(5-methyl-, compd. with benzenamine (1:2) EC / List no: - | CAS no: 63468-80-4
Anilinetrifluoroboron EC / List no: 211-539-8 | CAS no: 660-53-7
Anilinium acetate EC / List no: 208-802-4 | CAS no: 542-14-3
Anilinium bromide EC / List no: 208-801-9 | CAS no: 542-11-0
Dianilinium sulphate EC / List no: 208-805-0 | CAS no: 542-16-5
Aniline EC / List no: 200-539-3 | CAS no: 62-53-3
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-
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
1-chloro-4-nitrobenzene
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
1,4-dihydroxybenzene; hydroquinone; quinol
204-617-8
123-31-9
Carc. 2; Muta. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-(1-naphthylmethyl)quinolinium chloride
CIB R634
406-220-7
65322-65-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
C.I. Solvent Yellow 14; 1-phenylazo-2-naphthol
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
methylmercuric chloride
204-064-2
115-09-3
Carc. 2; Repr. 1A; Lact.; Acute Tox. 2; STOT RE 1
lead acetate, basic
215-630-3
1335-32-6
Carc. 2; Repr. 1A; STOT RE 2
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
nitrobenzene
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
carbetamide (ISO); (R)-1-(ethylcarbamoyl) ethyl carbanilate; (2R)-1-(ethylamino)-1-oxopropan-2-yl phenylcarbamate
240-286-6
16118-49-3
Carc. 2; Repr. 1B; Acute Tox. 4
flusilazole (ISO); bis(4-fluorophenyl)(methyl)(1H-1,2,4-triazol-1-ylmethyl)silane
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
reaction mass of: 4-[[bis-(4-fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole; 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole
R 7623 TECHNICAL
403-250-2
-
Carc. 2; Repr. 1B; Acute Tox. 4
tris(2-chloroethyl)phosphate
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
thiacloprid (ISO); (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide; {(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
ammonium nonadecafluorodecanoate
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
yes
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