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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
strophantin-K
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
styrene
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
succinic anhydride
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
sulphanilic acid; 4-aminobenzenesulphonic acid
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
sulphur dichloride
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
sulphur tetrachloride
-
13451-08-6
Skin Corr. 1B
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate
626-360-4
15244-35-6
yes
Tar acids, brown-coal, crude; Crude Phenols [n acidified alkaline extract of brown coal tar distillate.; Composed primarily of phenol and phenol homologs.]
An acidified alkaline extract of brown coal tar distillate. Composed primarily of phenol and phenol homologs.
309-888-7
101316-86-3
Carc. 1B; Muta. 1B
Tar brown-coal [An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one-to three-ring aromatic hydrocarbons, their alkyl derivates, heteroaromatics and one-and two-ring phenols boiling in the range of approximately 150°C to 360 °C (302°F to 680°F).]
An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivatives, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C (302°F to 680°F).
309-885-0
101316-83-0
Carc. 1A
Tar oils, coal, low-temp.; Tar Oil, high boiling [ distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160 °C to 340 °C (320°F to 644°F).]
A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C (320°F to 644°F).
309-889-2
101316-87-4
Carc. 1B; Muta. 1B
Tar, brown-coal, low-temp. [A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.]
A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
309-886-6
101316-84-1
Carc. 1A
Tar, coal, high-temp., residues; Coal Tar Solids Residue [Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.]
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
Tar, coal, low-temp, distn. residues; Tar Oil, intermediate boiling [Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300 °C (572 °F). Composed primarily of aromatic compounds.]
Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C (572°F). Composed primarily of aromatic compounds.
309-887-1
101316-85-2
Carc. 1B
tau-fluvalinate (ISO); cyano-(3-phenoxyphenyl)methyl N-[2-chloro-4-(trifluoromethyl)phenyl]-D-valinate
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
tebuconazole (ISO); 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
tebufenpyrad (ISO); N-(4-tertbutylbenzyl)-4-chloro-3-ethyl-1-methyl-1H-pyrazole-5-carboxamide
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
tecnazene (ISO); 1,2,4,5-tetrachloro-3-nitrobenzene
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
TEPP (ISO); tetraethyl pyrophosphate
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
tepraloxydim (ISO); (RS)-(EZ)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one
604-715-4
149979-41-9
Carc. 2; Repr. 2
terbufos (ISO); S-tert-butylthiomethyl O, O-diethylphosphorodithioate
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
tert-butyl (1R,5S)-3-azabicyclo[3.1.0]hex-6-ylcarbamate
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
tert-butyl acrylate
216-768-7
1663-39-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
tert-butyl methyl ether; MTBE; 2-methoxy-2-methylpropane
216-653-1
1634-04-4
Flam. Liq. 2; Skin Irrit. 2
tetra-ammonium 2-[6-[7-(2-carboxylato-phenylazo)-8-hydroxy-3,6-disulfonato-1-naphthylamino]-4-hydroxy-1,3,5-triazin-2-ylamino]benzoate
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
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
tetraammine palladium (II)hydrogen carbonate
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
tetraammine platinum (II); hydrogen carbonate
426-730-3
123439-82-7
Acute Tox. 4; Eye Dam. 1
tetraammonium 5-(4-(7-amino-1-hydroxy-3-sulfonato-2-naphthylazo)-6-sulfonato-1-naphthylazo)isophthalate
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
tetraboron disodium heptaoxide, hydrate
235-541-3
12267-73-1
Repr. 1B
yes
tetrabutylammonium 2-amino-6-iodopurinate
424-710-9
156126-48-6
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
tetrabutylammonium butyltriphenylborate
P3B
418-080-4
120307-06-4
Skin Sens. 1
tetracarbonylnickel; nickel tetracarbonyl
236-669-2
13463-39-3
Flam. Liq. 2; Carc. 2; Repr. 1B; Acute Tox. 2
tetrachloro-p-benzoquinone
204-274-4
118-75-2
Eye Irrit. 2; Skin Irrit. 2
tetrachloroethylene
204-825-9
127-18-4
Carc. 2
tetrachlorophthalic anhydride
204-171-4
117-08-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
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
tetracopper hexahydroxide sulphate
215-582-3
1333-22-8
Acute Tox. 4
tetracopper hexahydroxide sulphate hydrate
682-362-5
12527-76-3
Acute Tox. 4
tetracyclohexylstannane
215-910-5
1449-55-4
Acute Tox. 4
tetraethyl N, N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate
429-270-1
136210-30-5
Skin Sens. 1
tetrahydrofuran
203-726-8
109-99-9
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
tetrahydrofuran-2,5-diyldimethanol
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
tetrahydromethylphthalicanhydride
234-290-7
11070-44-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydrothiophene
203-728-9
110-01-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
tetrahydrothiophene-1,1-dioxide; sulpholane
204-783-1
126-33-0
Acute Tox. 4
tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate
432-770-2
139189-30-3
Skin Sens. 1
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(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(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
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