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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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
tetrasodium 4-[4-chloro-6-(4-methyl-2-sulfophenylamino)-1,3,5-triazin-2-ylamino]-6-(4,5-dimethyl-2-sulfophenylazo)-5-hydroxynaphthalene-2,7-disulfonate
AZO MONOCHLOROTRIAZINYL REACTIVE DYE; PROCION RED PX-6B COLOUR; SUBSTANCE S161057
415-400-4
148878-22-2
Eye Dam. 1; Skin Sens. 1
tetrasodium 4,4'-bis{4-[4-(2-hydroxyethylamino)-6-(4-sulfonatoanilino)-1,3,5-triazin-2-ylamino]phenylazo}stilbene-2,2'-disulfonate
429-230-3
371921-41-4
Eye Dam. 1
tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]; C.I. Direct Blue 6
220-012-1
2602-46-2
Carc. 1B; Repr. 2
tetrasodium 3,3'-(piperazine-1,4-diylbis((6-chloro-1,3,5-triazine-2,4-diyl)imino(2-acetamido)-4,1-phenyleneazo))bis(naphthalene-1,5-disulphonate)
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
tetrasodium 2-(6-chloro-4-(4-(2,5-dimethyl-4-(2,5-disulphonatophenylazo)phenylazo)-3-ureidoanilino)-1,3,5-triazin-2-ylamino)benzene-1,4-disulphonate
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate
432-550-6
243858-01-7
Eye Dam. 1
tetrasodium 10-amino-6,13-dichloro-3-(3-(4-(2,5-disulfonatoanilino)-6-fluoro-1,3,5-triazin-2-ylamino)prop-3-ylamino)-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
BLEU DIOXAZINA ST 7005; BLEU DIOXAZINE ST 7005; DIOXAZIN BLAU ST 7005; DIOXAZINE BLUE ST 7005
402-590-9
109125-56-6
Eye Dam. 1
tetrasodium 1,2-bis(4-fluoro-6- [5-(1-amino-2-sulfonatoanthra chinon-4-ylamino)-2,4,6- trimethyl-3-sulfonatopheny lamino]-1,3,5-triazin-2- ylamino)ethane
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
tetrasodium (c-(3-(1-(3-(e-6-dichloro-5-cyanopyrimidin-f-yl(methyl)amino)propyl)-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)-4-sulfonatophenylsulfamoyl)phthalocyanine-a, b,d-trisulfonato(6-))nickelato II, where a is 1 or 2 or 3 or 4,b is 8 or 9 or 10 or 11,c is 15 or 16 or 17 or 18, d is 22 or 23 or 24 or 25 and where e and f together are 2 and 4 or 4 and 2 respectively
BRILLANTGREEN K-RWA 6083; BRILLIANT GREEN K-RWA 6083
410-160-7
148732-74-5
Eye Irrit. 2; Skin Sens. 1
tetrapropan-2-yl (dichloromethanediyl)bis(phosphonate)
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
tetrapotassium 4-[5-[3-carboxylato-4,5-dihydro-5-oxo1-(4-sulfonatophenyl)pyrazol-4-ylidene]-3-(piperidinocarbonyl)penta-1,3-dienylidene]-5-hydroxy-1-(4-sulfonatophenyl)pyrazole-3-carboxylate
430-390-1
845730-14-5
Acute Tox. 4
tetrapotassium 2-(4-(5-(1-(2,5- disulfonatophenyl)-3-ethoxycar bonyl-5-hydroxypyrazol-4- yl)penta-2,4-dienylidene)-3- ethoxycarbonyl-5-oxo-2-pyra zolin-1-yl)benzene-1,4- disulfonate
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
tetraphosphorus trisulphide; phosphorus sesquisulphid
215-245-0
1314-85-8
Flam. Sol. 2; Water-react. 1; Acute Tox. 4
tetramethylthiuram monosulphide
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
tetramethylene diacrylate; 1,4-butyleneglycol diacrylate
213-979-6
1070-70-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
tetramethylammonium hydrogen phthalate
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 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
tetralithium 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
tetralithium 2-[6-[7-[2-(carboxylato)phenylazo]-8-hydroxy-3,6-disulfonato-1-naphthylamino]-4-hydroxy-1,3,5-triazine-2-ylamino]benzoate
440-460-3
252579-81-0
Eye Irrit. 2
Tetralead trioxide sulphate
235-380-9
12202-17-4
yes
tetrakis(trimethylhexadecylammonium) hexa-mu-oxotetra-mu3-oxodi-mu5-oxotetradecaoxooctamolybdate(4-)
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
tetrakis(tetramethylammonium); 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
tetrakis(tetramethylammonium)3,3'-(6-(2-hydroxyethylamino)1,3,5-triazine-2,4-diylbisimino(2-methyl-4,1-phenyleneazo))bisnaphthalene-1,5-disulfonate
DIRECT YELLOW 86 TETRAMETHYLAMMONIUM SALT; YELLOW DYE FOR PAINTJET PRINT CARTRIDGE
405-950-3
131013-83-7
Acute Tox. 3
tetrakis(dimethylditetradecylammonium) hexa-μ-oxotetra-μ3-oxodi-μ5-oxotetradecaoxooctamolybdate(4-)
SUBSTANCE TP-415; SUBSTANZ TP-415; TP-415
404-760-8
117342-25-3
Acute Tox. 3; Eye Dam. 1
tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate
432-770-2
139189-30-3
Skin Sens. 1
tetrakis(1,2,2,6,6-pentamethyl-4-piperidyl)-1,2,3,4-butanetetracarboxylate
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
tetrahydrothiopyran-3-carboxaldehyde
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
tetrahydrothiophene-1,1-dioxide; sulpholane
204-783-1
126-33-0
Acute Tox. 4
tetrahydrothiophene
203-728-9
110-01-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
tetrahydrophthalic anhydride
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydromethylphthalicanhydride
234-290-7
11070-44-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydrofuran-2,5-diyldimethanol
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
tetrahydrofuran
203-726-8
109-99-9
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
tetrahydro-4-methylphthalicanhydride
251-823-9
34090-76-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydro-2-isobutyl-4-methylpyran-4-ol, mixed isomers (cis and trans)
CIS/TRANS-TIMO; FLOROL; FLOROSA
405-040-6
63500-71-0
Eye Irrit. 2
tetrahydro-2-furyl-methanol; tetrahydrofurfuryl alcohol
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one; dimethyl propyleneurea
230-625-6
7226-23-5
Repr. 2; Acute Tox. 4; Eye Dam. 1
Tetraethyllead
201-075-4
78-00-2
yes
tetraethyl silicate; ethyl silicate
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
tetraethyl N, N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate
429-270-1
136210-30-5
Skin Sens. 1
tetradecylammonium bis(1-(5-chloro-2-oxidophenylazo)-2-naphtholato)chromate(1-)
KAYASET BLACK T-2
405-110-6
88377-66-6
STOT RE 2
tetracyclohexylstannane
215-910-5
1449-55-4
Acute Tox. 4
tetracopper hexahydroxide sulphate hydrate
682-362-5
12527-76-3
Acute Tox. 4
tetracopper hexahydroxide sulphate
215-582-3
1333-22-8
Acute Tox. 4
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
tetrachloroplatinates with the exception of those specified elsewhere in this Annex
show/hide
Diamminetetrachloroplatinum EC / List no: 240-930-6 | CAS no: 16893-05-3
Disodium tetrachloroplatinate EC / List no: 233-051-4 | CAS no: 10026-00-3
Dipotassium tetrachloroplatinate EC / List no: 233-050-9 | CAS no: 10025-99-7
Diammonium tetrachloroplatinate EC / List no: 237-499-1 | CAS no: 13820-41-2
Dirubidium tetrachloroplatinate EC / List no: 237-503-1 | CAS no: 13820-56-9
Platinate(2-), tetrachloro-, dihydrogen, (SP-4-1) EC / List no: - | CAS no: 17083-70-4
Tetraammineplatinum tetrachloroplatinate EC / List no: 237-501-0 | CAS no: 13820-46-7
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-
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrachlorophthalic anhydride
204-171-4
117-08-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrachloroethylene
204-825-9
127-18-4
Carc. 2
tetrachloro-p-benzoquinone
204-274-4
118-75-2
Eye Irrit. 2; Skin Irrit. 2
tetracarbonylnickel; nickel tetracarbonyl
236-669-2
13463-39-3
Flam. Liq. 2; Carc. 2; Repr. 1B; Acute Tox. 2
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