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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 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
2-ethoxyethanol; ethylene glycol monoethyl ether
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
2-ethoxyethyl 2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
2-ethoxyethyl acetate; ethylglycol acetate
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
2-ethylhexanoic acid
205-743-6
149-57-5
Repr. 2
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; [DOTE]
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
2-ethylhexyl acrylate
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
2-ethylphenylhydrazine hydrochloride
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-hexyloxyethanol; ethylene glycol monohexyl ether; n-hexylglycol
203-951-1
112-25-4
Acute Tox. 4; Skin Corr. 1B
2-hydroxy-3-[(2-hydroxyethyl)-[2-(1-oxotetradecyl)amino]ethyl]amino]-N,N,N-trimethyl-1-propanammonium chloride
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
2-hydroxyethylammonium perbromide
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
2-isobutyl-2-isopropyl-1,3-dimethoxypropane
430-800-9
129228-21-3
Skin Irrit. 2
2-isopropoxyethanol; ethylene glycol monoisopropyl ether
203-685-6
109-59-1
Acute Tox. 4; Eye Irrit. 2
2-isopropyl-2-(1-methylbutyl)-1,3-dimethoxypropane
406-970-5
129228-11-1
Skin Irrit. 2
2-isopropyl-4-(N-methyl)aminomethylthiazole
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-isopropyl-5-methylcyclohexyloxycarbonyloxy-2-hydroxypropane
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
2-methoxy-1-methylethyl acetate
203-603-9
108-65-6
Flam. Liq. 3
2-methoxyethanol; ethylene glycol monomethyl ether
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
2-methoxyethyl acetate; methylglycol acetate
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
2-methoxyethylmercury chloride
204-659-7
123-88-6
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-methoxypropanol
216-455-5
1589-47-5
Flam. Liq. 3; Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
2-methyl-1,5-pentanediamine-1,3-benzenedicarboxylate
433-910-5
145153-52-2
Skin Sens. 1
2-methyl-1-pentylpyridinium bromide
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
2-methyl-3-(trimethoxysilyl)propyl-2-propenoate hydrolysis product with silica
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
2-methyl-4-(1,1-dimethylethyl)-6-(1-methyl-pentadecyl)-phenol
CG 31-1919
410-760-9
157661-93-3
Skin Irrit. 2; Skin Sens. 1
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-methylaminoethanol; N-methylethanolamine; N-methyl-2-ethanolamine; N-methyl-2-amino ethanol; 2-(methylamino)ethanol
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
2-methylpentane-2,4-diol
203-489-0
107-41-5
Eye Irrit. 2; Skin Irrit. 2
2-methylpropene
204-066-3
115-11-7
Flam. Gas 1; Press. Gas
2-methylpyridine; 2-picoline
203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
2-naphthol
205-182-7
135-19-3
Acute Tox. 4
2-naphthylamino-6-sulfomethylamide
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
2-phenoxyethanol
204-589-7
122-99-6
Acute Tox. 4; Eye Irrit. 2
2-phenyl-1,3-propanediol
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
2-phenylethylisocyanate
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
2-phenylthioaniline
2-ADPS
413-030-8
1134-94-7
Skin Sens. 1
2-phthalimidoethyl N-[4-(2-cyano-4-nitrophenylazo)phenyl]-N-methyl-β-alaninate
426-400-9
170222-39-6
Skin Sens. 1
2-piperazin-1-ylethylamine
205-411-0
140-31-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-{2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethoxy}ethanol
687-833-9
1119449-38-5
yes
26-(4-nonylphenoxy)-3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol
604-395-6
14409-72-4
yes
2S-isopropyl-5R-methyl-1R-cyclohexyl 2,2-dihydroxyacetate
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
3'-trifluoromethylisobutyranilide
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
3(or 5)-(4-(N-benzyl-N-ethylamino)-2-methylphenylazo)1,4-dimethyl-1,2,4-triazolium methylsulphate
BASIC RED FC 48215
406-055-0
124584-00-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3,3'-dimethoxybenzidine; o-dianisidine
204-355-4
119-90-4
Carc. 1B; Acute Tox. 4
3,4-dihydroxy-5-nitrobenzaldehyde
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3,5-bis-(tetradecyloxycarbonyl)benzenesulfinic acid
AF-389
407-990-7
141915-64-2
Skin Sens. 1
3,5-dichloro-2,4-difluorobenzoyl fluoride
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)aniline
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)aniline
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
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