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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine
432-840-2
220926-97-6
Acute Tox. 4
2,2' -oxybisethanol; diethylene glycol
203-872-2
111-46-6
Acute Tox. 4
2,2,4-trimethyl-4-phenyl-butane-nitrile
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
2,3,6-TBA (ISO); 2,3,6-trichlorobenzoic acid
200-026-4
50-31-7
Acute Tox. 4
2,4-DB (ISO); 4-(2,4-dichlorophenoxy)butyric acid
202-366-9
94-82-6
Acute Tox. 4
2,5-dihydroxy-5-methyl-3-(morpholin-4-yl)-2-cyclopenten-1-one
430-170-5
114625-74-0
Acute Tox. 4
2,6-diethylaniline
209-445-7
579-66-8
Acute Tox. 4
2-(2-bromoethoxy)anisole
GUAIACOL-O-ETHYLBROMIDE
402-010-4
4463-59-6
Acute Tox. 4
2-(2-iodoethyl)-1,3-propanediol diacetate
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
2-[(4-chloro-2-nitrophenyl)amino]ethanol
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
2-amino-4,6-dinitrophenol; picramic acid;2-amino-4,6-dinitrophenol; picramic acid [≥ 20 % water]
202-544-6
96-91-3
Acute Tox. 4
2-amino-4-chloro-6-methoxypyrimidine
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
2-amino-6-ethoxy-4-methylamino-1,3,5-triazine
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
2-benzyl-2-methyl-3-butenitrile
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
2-bromo-4,6-difluoroaniline
429-430-0
444-14-4
Acute Tox. 4
2-butoxyethyl acetate; butylglycol acetate
203-933-3
112-07-2
Acute Tox. 4
2-chloro-4-nitroaniline
204-502-2
121-87-9
Acute Tox. 4
2-chlorophenol
202-433-2
95-57-8
Acute Tox. 4
2-chlorotoluene
202-424-3
95-49-8
Acute Tox. 4
2-cyclohexylidene-2-phenylacetonitrile
423-740-1
10461-98-0
Acute Tox. 4
2-ethylbutan-1-ol
202-621-4
97-95-0
Acute Tox. 4
2-methyl-1-pentylpyridinium bromide
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
2-methyl-4-oxo-3-(penta-2,4- dienyl)cyclopent-2-enyl [1R- [1α[S*(Z)],3β]]-chrysanthemate; pyrethrin I
204-455-8
121-21-1
Acute Tox. 4
2-methyl-4-oxo-3-(penta-2,4- dienyl)cyclopent-2-enyl[1R- [1α[S*(Z)](3β)]]-3-(3-methoxy-2-methyl-3-oxoprop-1-enyl)-2,2- dimethylcyclopropanecar boxylate; pyrethrin II
204-462-6
121-29-9
Acute Tox. 4
2-methylcyclohexanol, mixed isomers
209-512-0
583-59-5
Acute Tox. 4
2-methylstyrene; 2-vinyltoluene
210-256-7
611-15-4
Acute Tox. 4
2-naphthol
205-182-7
135-19-3
Acute Tox. 4
2-phenylhexanenitrile
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4
3,5-dichloro-2,6-difluoropyrdine-4-amine
220-630-1
2840-00-8
Acute Tox. 4
3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)aniline
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
3,9-bis(2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy-1,1-dimethylethyl)-2,4,8,10-tetraoxaspiro[5.5]undecane
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
3-((2-nitro-4-(trifluoromethyl)phenyl)amino)propane-1,2-diol
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
3-(N-methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol hydrochloride
IMEXINE FAE
403-440-5
93633-79-5
Acute Tox. 4
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione; dehydracetic acid
208-293-9
520-45-6
Acute Tox. 4
3-aminobenzene sulphonic acid; metanilic acid
204-473-6
121-47-1
Acute Tox. 4
3-aminophenol
209-711-2
591-27-5
Acute Tox. 4
3-chloro-5-trifluoromethyl-2- pyridylamine
ACTF; P-007
401-670-0
79456-26-1
Acute Tox. 4
3-chlorophenol
203-582-6
108-43-0
Acute Tox. 4
3-chlorotoluene
203-580-5
108-41-8
Acute Tox. 4
3-hexylheptamethyltrisiloxane
428-700-5
1873-90-1
Acute Tox. 4
3-N, N-bis(methoxyethyl)aminoacetanilide
432-530-7
24294-01-7
Acute Tox. 4
4,4,5,5,5-pentafluoropentan-1-ol
421-360-9
148043-73-6
Acute Tox. 4
4-(4,4-dimethyl-3-oxo-pyrazolidin-1-yl)-benzoic acid
CARBODIM
413-120-7
107144-30-9
Acute Tox. 4
4-[4-(2-ethylhexyloxy)phenyl](1,4-thiazinane-1,1-dioxide)
CIN 10097929
418-320-8
133467-41-1
Acute Tox. 4
4-chlorophenol
203-402-6
106-48-9
Acute Tox. 4
4-chlorotoluene
203-397-0
106-43-4
Acute Tox. 4
4-CPA (ISO); 4-chlorophenoxyacetic acid
204-581-3
122-88-3
Acute Tox. 4
4-nitrosoaniline
211-535-6
659-49-4
Acute Tox. 4
5(or 6)-tert-butyl-2'-chloro-6'-ethylamino-3',7'-dimethylspiro(isobenzofuran-1(1H),9'-xanthene)-3-one
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
5,6-dihydro-3H-imidazo[2,1-c]-1,2,4-dithiazole-3-thione; etem
251-684-4
33813-20-6
Acute Tox. 4
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