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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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
Toxocara canis
-
-
P Parasites
Toxoplasma gondii
-
-
P Parasites
tralkoxydim (ISO); 2-(N-ethoxypropanimidoyl)-3-hydroxy-5-mesitylcyclohex-2-en-1-one
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
trans-(4S,6S)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-4-ol, 7,7-dioxide
FC4010
417-290-3
147086-81-5
Acute Tox. 4
trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
trans-1-methyl-4-(1-methylvinyl)cyclohexene
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
trans-2-isopropyl-5-carboxy-1,3-dioxane
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
trans-2-methylcyclohexanol
231-186-3
7443-52-9
Acute Tox. 4
trans-4-cyclohexyl-L-proline monohydrochloride
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
trans-4-phenyl-L-proline
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
trans-cyclohexane-1,2-dicarboxylic anhydride
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
trans-dichloroethylene
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
trans-isopropyl-3-[[(ethylamino)methoxyfosfinothioyl]oxy]crotonate; isopropyl 3-[[(ethylamino)methoxyphosphinothioyl]oxy]isocrotonate; propetamphos (ISO)
250-517-2
31218-83-4
Acute Tox. 3
trans-methyl-2-ethyl-but-2-enoate
443-150-6
101226-85-1
Flam. Liq. 3
transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl trans-2-(2,2-dichlorovinyl)-3,3-dimethylcyclopropanecarboxylate
405-060-5
118712-89-3
Skin Irrit. 2
trans—N-methyl-2-styryl-[4'- aminomethine-(1-acetyl-1-(2- methoxyphenyl)acetamido)]py ridinium acetate
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
Treponema carateum
-
-
B Bacteria and similar species
Treponema pallidum
-
-
B Bacteria and similar species
Treponema pertenue
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-
B Bacteria and similar species
Treponema spp.
-
-
B Bacteria and similar species
tri-allate (ISO); S-2,3,3-trichloroallyl diisopropylthiocarbamate
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
tri-methylamine;tri-methylamine ... %
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
tri-methylamine;tri-methylamine ... %
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
triadimefon (ISO); 1-(4-chlorophenoxy)-3,3-dimethyl-1-(1,2,4-triazol-1-yl)butanone
256-103-8
43121-43-3
Acute Tox. 4; Skin Sens. 1
triadimenol (ISO); (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol
259-537-6
55219-65-3
Repr. 1B; Lact.; Acute Tox. 4
trialkylboranes, solid
-
-
Pyr. Liq. 1; Skin Corr. 1B
triamiphos (ISO); 5-amino-3-phenyl-1,2,4-triazol-1-yl-N, N,N',N'-tetramethylphosphonic diamide
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
triammonium 4-[4-[7-(4-carboxylatoanilino)-1-hydroxy3-sulfonato-2-naphthylazo]-2,5-dimethoxyphenylazo]benzoate
432-270-4
221354-37-6
Repr. 2; STOT RE 2
triarimol (ISO); 2,4-dichloro-α-(pyrimidin-5-yl)benzhydryl alcohol
-
26766-27-8
Acute Tox. 4
triazophos (ISO); O, O-diethyl-O-1-phenyl-1H-1,2,4-triazol-3-yl phosphorothioate
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
tribenuron-methyl (ISO); 2-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid methyl ester; methyl 2-(3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3methylureidosulfonyl)benzoate
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
tributyl phosphate
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
tributyltetradecylphosphonium tetrafluoroborate
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
tributyltin compounds, with the exception of those specified elsewhere in this Annex
-
-
Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
Trichinella spiralis
-
-
P Parasites
trichlorfon (ISO); dimethyl 2,2,2-trichloro-1-hydroxyethylphosphonate
200-149-3
52-68-6
Acute Tox. 4; Skin Sens. 1
trichloro(methyl)silane; methyltrichlorosilane
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
trichloroacetonitrile
208-885-7
545-06-2
Acute Tox. 3
trichloroethylene; trichloroethene
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
trichloromethylstannane
213-608-8
993-16-8
Repr. 2
trichloronate (ISO); O-ethyl O-2,4,5-trichlorophenyl ethylphosphonothioate
206-326-1
327-98-0
Acute Tox. 2; Acute Tox. 3
trichloronitromethane; chloropicrin
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
trichlorosilane
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
Trichophyton rubrum
-
-
F Fungi
Trichophyton spp.
-
-
F Fungi
Trichuristrichiura
-
-
P Parasites
triclosan;2,4,4'-trichloro-2'-hydroxy-diphenyl-ether; 5-chloro-2-(2,4-dichlorophenoxy)phenol
222-182-2
3380-34-5
Eye Irrit. 2; Skin Irrit. 2
Tricosafluorododecanoic acid
206-203-2
307-55-1
yes
tricresyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-); tritolyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-);tricresyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-); tritolyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-)
215-548-8
1330-78-5
STOT SE 1
tricresyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-); tritolyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-);tricresyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-); tritolyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-)
215-548-8
1330-78-5
Acute Tox. 4
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