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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
tridemorph (ISO); 2,6-dimethyl-4-tridecylmorpholine
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1)
274-462-9
70225-16-0
yes
tricyclazole (ISO); 5-methyl-1,2,4-triazolo(3,4-b)benzo-1,3-thiazole
255-559-5
41814-78-2
Acute Tox. 4
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
Tricosafluorododecanoic acid
206-203-2
307-55-1
yes
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
Trichuristrichiura
-
-
P Parasites
Trichophyton spp.
-
-
F Fungi
Trichophyton rubrum
-
-
F Fungi
trichlorosilane
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
trichloronitromethane; chloropicrin
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
trichloronate (ISO); O-ethyl O-2,4,5-trichlorophenyl ethylphosphonothioate
206-326-1
327-98-0
Acute Tox. 2; Acute Tox. 3
trichloromethylstannane
213-608-8
993-16-8
Repr. 2
trichloroethylene; trichloroethene
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
trichloroacetonitrile
208-885-7
545-06-2
Acute Tox. 3
trichloro(methyl)silane; methyltrichlorosilane
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
trichlorfon (ISO); dimethyl 2,2,2-trichloro-1-hydroxyethylphosphonate
200-149-3
52-68-6
Acute Tox. 4; Skin Sens. 1
Trichinella spiralis
-
-
P Parasites
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
tributyltetradecylphosphonium tetrafluoroborate
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
tributyl phosphate
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
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
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
triarimol (ISO); 2,4-dichloro-α-(pyrimidin-5-yl)benzhydryl alcohol
-
26766-27-8
Acute Tox. 4
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
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
trialkylboranes, solid
-
-
Pyr. Liq. 1; Skin Corr. 1B
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
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
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
tri-allate (ISO); S-2,3,3-trichloroallyl diisopropylthiocarbamate
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Treponema spp.
-
-
B Bacteria and similar species
Treponema pertenue
-
-
B Bacteria and similar species
Treponema pallidum
-
-
B Bacteria and similar species
Treponema carateum
-
-
B Bacteria and similar species
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
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-methyl-2-ethyl-but-2-enoate
443-150-6
101226-85-1
Flam. Liq. 3
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-dichloroethylene
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
trans-cyclohexane-1,2-dicarboxylic anhydride
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
trans-4-phenyl-L-proline
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
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-2-methylcyclohexanol
231-186-3
7443-52-9
Acute Tox. 4
trans-2-isopropyl-5-carboxy-1,3-dioxane
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
trans-1-methyl-4-(1-methylvinyl)cyclohexene
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
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
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