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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 03 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
trimethylenediaminetetraacetic acid
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
trinickel bis(arsenate); nickel(II) arsenate
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
trinickel bis(orthophosphate)
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
trinickel boride
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
trinickel disulfide; nickel subsulfide
234-829-6
12035-72-2
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
trinickel tetrasulfide
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
triphenyl phosphite
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
tris(2-chloroethyl)phosphate
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane
213-934-0
1067-53-4
Repr. 1B
tris(octadec-9-enylammonium) (trisulfonatophthalocyaninato)copper(II)
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
tris(tetramethylammonium) 5-hydroxy-1-(4-sulphonatophenyl)-4-(4-sulphonatophenylazo)pyrazole-3-carboxylate
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
tris[2-chloro-1-(chloromethyl)ethyl] phosphate
237-159-2
13674-87-8
Carc. 2
trisodium (6-anilino-2-(5-nitro-2-oxidophenylazo)-3-sulphonato-1-naphtholato)(4-sulphonato-1,1'-azodi-2,2'naphtholato)chromate(1-)
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
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
trisodium 3-amino-6,13-dichloro-10-((3-((4-chloro-6-(2-sulfophenylamino)-1,3,5-triazin-2-yl)amino)propyl) amino)-4,11-triphenoxydioxazinedisulfonate
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
trisodium 7-(4-(6-fluoro-4-(2-(2-vinylsulphonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulphonate
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
trisodium [4'-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4''-(6-benzoylamino-3-sulfonato2-naphthylazo)-biphenyl 1,3',3'',1'''-tetraolato-O,O',O'',O''']copper(II)
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulphonato-1-naphtholato)chromate(1-)
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
trisodium hexafluoroaluminate
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
trisodium hexafluoroaluminate(cryolite)
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
trisodium N, N-bis(carboxymethyl)-3-amino-2-hydroxypropionate
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
trisodium N, N-bis(carboxymethyl)-β-alanine
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
trisodium N-(3-propionato)-l-aspartate
422-090-4
172737-80-3
Eye Dam. 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
tritosulfuron (ISO) (containing ≤0,02 % AMTT); 1-[4-methoxy-6-(trifluoromethyl)-1,3,5-triazin-2-yl]-3-[2-(trifluoromethyl)benzenesulfonyl]urea (containing ≤ 0,02 % AMTT)
604-291-0
142469-14-5
Skin Sens. 1
trizinc diphosphide; zinc phosphide
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
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
valeric acid
203-677-2
109-52-4
Skin Corr. 1B
vernolate (ISO); S-propyl dipropylthiocarbamate
217-681-7
1929-77-7
Acute Tox. 4
vinyl acetate
203-545-4
108-05-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3
white phosphorus
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
xylene
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
xylenol
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
xylidines with the exception of those specified elsewhere in this Annex; dimethyl anilines with the exception of those specified elsewhere in this Annex
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
zinc 2-hydroxy-5-C13-18 alkylbenzoate
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2
zinc bis(dibutyldithiocarbamate)
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
zinc bis(diethyldithiocarbamate)
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
zinc-bis(4-(n-octyloxycarbonylamino)salicylate) dihydrate
417-130-2
1379689-21-0
Eye Dam. 1
zineb (ISO); zinc ethylenebis(dithiocarbamate) (polymeric)
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
ziram (ISO); zinc bis dimethyldithiocarbamate
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
zoxamide (ISO); (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide
605-037-1
156052-68-5
Skin Sens. 1
α-[3-(1-oxoprop-2-enyl)l-1-oxypropyl]dimethoxysilyloxy-ω-[3(1-oxoprop-2-enyl)-1-oxypropyl]dimethoxysilyl poly(dimethylsiloxane)
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
α-bromotoluene; benzyl bromide
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
α-chlorotoluene; benzyl chloride
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α-hydroxypoly(methyl-(3-(2,2,6,6-tetramethylpiperidin-4-yloxy)propyl)siloxane)
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
α[2-[[[(2-hydroxyethyl)methylamino]acetyl]amino]propyl]-ω nonylphenoxy)poly[oxo(methyl-1,2-ethanediyl)]
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
ε-caprolactam
203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
(1R,3S,7R,8R,10R,13R)-5,5,7,9,9,13-hexamethyl-4,6-dioxatetracyclo[6.5.1.01,10.03,7]tetradecane
427-580-1
211299-54-6
Skin Irrit. 2
(1α,2α,3β,6β)-1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
(1α5α6α)-6-nitro-3-benzyl-3-azabicyclo[3.1.0]hexane methanesulfonate salt
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 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-ammonio-m-tolyl)ethyl(2-hydroxyethyl)ammonium sulphate; 4-(N-ethyl-N-2-hydroxyethyl)-2-methylphenylenediamine sulphate
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
(9S)-9-amino-9-deoxyerythromycin
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
(benzothiazol-2-ylthio)methyl thiocyanate; TCMTB
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
(R)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
(R)-α-phenylethylammonium(-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
(S)-2-chloropropionic acid
L-2-CHLOROPROPIONIC ACID; L-2-CHLORPROPIONSÄURE
411-150-5
29617-66-1
Acute Tox. 4; Skin Corr. 1A
(S)-azetidine-2-carboxylic acid; 4-cyanobenzylamide hydrochloride
433-010-2
2135910-74-4
Acute Tox. 4; Skin Sens. 1
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
1,1,3,3-tetramethylbutylperoxypivalate
424-980-8
22288-41-1
Flam. Liq. 2; Org. Perox. D; Skin Irrit. 2; Skin Sens. 1
1,1-dimethylpiperidinium chloride; mepiquat chloride
246-147-6
24307-26-4
Acute Tox. 4
1,2,3,6-tetrahydromethylphthalic anhydride
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,4-triazole
206-022-9
288-88-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
1,2-benzisothiazol-3(2H)-one;1,2-benzisothiazolin-3-one
220-120-9
2634-33-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione; TGIC
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
1,4,5,8-tetraaminoanthra; quinone; C.I. Disperse Blue 1
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1,4,7,10-tetraazacyclododecane
425-450-9
294-90-6
Skin Corr. 1B; Acute Tox. 4
1,4-bis(2,3 epoxypropoxy)butane; butanedioldiglycidyl ether
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate
429-370-5
220410-74-2
Acute Tox. 4
1,5-naphthylenediamine
218-817-8
2243-62-1
Carc. 2
1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing < 0,1 % 4-chloroaniline (EC No 203-401-0)];1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing ≥ 0,1 % 4-chloroaniline (EC No 203-401-0)]
433-580-2
214353-17-0
Acute Tox. 4; Skin Corr. 1B
1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing < 0,1 % 4-chloroaniline (EC No 203-401-0)];1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing ≥ 0,1 % 4-chloroaniline (EC No 203-401-0)]
433-580-2
214353-17-0
Carc. 1B; Acute Tox. 4; Skin Corr. 1B
1-(2-butoxypropoxy)propan-2-ol
246-011-6
24083-03-2
Acute Tox. 4
1-(2-propenyl)pyridinium chloride
GOLPANOL APC
412-740-5
25965-81-5
Acute Tox. 4; Skin Sens. 1
1-(4-(trans-4-ethylcyclohexyl)phenyl)ethanone
4-(4-ETHYLCYCLOHEXYL)-ACETOPHENON
426-460-6
260415-81-4
Skin Sens. 1
1-[4-(4-benzoylphenylsulfanyl)phenyl]-2-methyl-2-(4-methylphenylsulfonyl)propan-1-one
429-040-0
272460-97-6
Eye Dam. 1
1-butyl-2-methylpyridinium bromide
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
1-dimethoxymethyl-2-nitro-benzene
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
1-dodecyl-2-pyrrolidone
SURFADONE LP-300 SURFACTANT
403-730-1
2687-96-9
Skin Corr. 1B; Skin Sens. 1
1-hydroxybenzotriazole, anhydrous
219-989-7
2592-95-2
Expl. 1.3
12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine
432-840-2
220926-97-6
Acute Tox. 4
2,2'-azobis[2-methylpropionamidine] dihydrochloride
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
2,2'-dithio di(ethylammonium)-bis(dibenzyldithiocarbamate)
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
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
2,2-dichloro-1,3-benzodioxol
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
2,2-dimethyl-1,3-benzodioxol-4-ol
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
2,2-dimethyltrimethylene diacrylate; neopentyl glycol diacrylate
218-741-5
2223-82-7
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionyl fluoride
218-173-8
2062-98-8
yes
2,3,4-trichlorobut-1-ene
219-397-9
2431-50-7
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (1R,3R)-2,2-dimethyl-3-[(1Z)-prop-1-en-1-yl]cyclopropanecarboxylate; epsilon-metofluthrin
-
240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
2,3-epoxypropyl o-tolyl ether
218-645-3
2210-79-9
Muta. 2; Skin Irrit. 2; Skin Sens. 1
2,4,4-trimethylpentene
246-690-9
25167-70-8
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
2,4,5-trimethylaniline hydrochloride
-
21436-97-5
Carc. 1B; Acute Tox. 3
2,4-diamino-3,5-diethyltoluene; 2,4-diethyl-6-methyl-1,3-benzenediamine
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-diamino-5-[4-[(2-sulfoxyl ethyl)sulfonyl]phenylazo]benzenesulfonic acid
424-870-1
27624-67-5
Expl. 1.1; Eye Dam. 1
2,6-diamino-3,5-diethyltoluene; 4,6-diethyl-2-methyl-1,3-benzenediamine
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,6-diamino-3-((pyridine-3-yl)azo)pyridine
AZOGELB
421-430-9
28365-08-4
Acute Tox. 4; STOT RE 2
2,6-dichloro-4-trifluoromethylaniline
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol; UV-328
247-384-8
25973-55-1
yes
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