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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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-(3,4-dichlorophenyl)-4-methyl-1,2,4-oxadiazolidinedione; methazole
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-(3-(prop-1-en-2-yl)phenyl)prop-2-yl isocyanate
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1
2-(5,5-dimethyl-2,4-dioxooxazolidin-3-yl)-4,4-dimethyl-3-oxo-N-(2-methoxy-5-octadecanoylaminophenyl)pentanoic acid amide
443-980-9
221215-20-9
Skin Sens. 1
2-(propyloxy)ethanol; EGPE
220-548-6
2807-30-9
Acute Tox. 4; Eye Irrit. 2
2-[2-(4-nonylphenoxy)ethoxy]ethanol
243-816-4
20427-84-3
yes
2-acetoxymethylene-4-acetylphenylacetate
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-bromo-2-nitropropanol
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-bromo-5-hydroxy-4-methoxybenzaldehyde
426-540-0
2973-59-3
Skin Sens. 1
2-bromomalonaldehyde
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
2-chloro-6-fluoro-phenol
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-cyclohexylpropanal
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
2-dimethylaminoethyl methacrylate
220-688-8
2867-47-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-hydroxy-1-methylethylacrylate
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-methyl-1,2-benzothiazol-3(2H)-one; [MBIT]
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
2-methyl-5-phenylpentanol
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
2-methylbutyl propionate
219-449-0
2438-20-2
Flam. Liq. 3
2-methylisothiazol-3(2H)-one
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
2-thiazolidinylidenecyanamide
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
20-(4-nonylphenoxy)-3,6,9,12,15,18-hexaoxaicosan-1-ol
248-743-1
27942-27-4
yes
20-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-3,6,9,12,15,18-hexaoxaicosan-1-ol
219-682-8
2497-59-8
yes
26-(nonylphenoxy)-3,6,9,12,15,18,21,24-octaoxahexacosan-1-ol
247-816-5
26571-11-9
yes
3,4,3', 4'-tetraphenyl-1,1'-ethandiylbispyrol-2,5-dione
431-500-0
226065-73-2
Skin Sens. 1
3,4,5,6-tetrahydrophthalic anhydride
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
3,4-dimethyl-1H-pyrazole
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
3,5-dichloro-2,6-difluoropyrdine-4-amine
220-630-1
2840-00-8
Acute Tox. 4
3,6-dichloro-o-anisic acid, compound with dimethylamine (1:1)
218-951-7
2300-66-5
Eye Irrit. 2
3-(3-amino-5-(1-methylguanidino)-1-oxopentylamino-6-(4-amino-2-oxo-2,3-dihydro-pyrimidin-1-yl)-2,3-dihydro-(6H)-pyran-2-carboxylic acid; blasticidin-s
606-640-2
2079-00-7
Acute Tox. 2
3-(4-aminophenyl)-2-cyano-2-propenoic acid
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
3-aminomethyl-3,5,5-trimethylcyclohexylamine
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-chloro-4-(3-fluorobenzyloxy)aniline
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
3-hydroxypropyl methacrylate
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
3-methylpyrazol-5-yl-dimethylcarbamate; monometilan
-
2532-43-6
Acute Tox. 3
3-N, N-bis(methoxyethyl)aminoacetanilide
432-530-7
24294-01-7
Acute Tox. 4
4'-fluoro-2,2-dimethoxyacetophenone
DMA
407-500-1
21983-80-2
Skin Sens. 1
4,4'-thiodi-o-cresol
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
4,4,5,5-tetrachloro-1,3-dioxolan-2-one
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
621-341-7
2315-61-9
yes
4-(5-(5-[1-(4-carboxyphenyl)hexahydro-2,4,6-trioxopyrimidin-5-ylidene]penta-1,3-dienyl)-1,2,3,4-tetrahydro-6-hydroxy-2,4-dioxopyrimidin-1-yl)benzoic acid-triethylamine salt
426-900-7
203118-12-1
STOT SE 3
4-(cyanomethyl)-4-methylmorpholin-4-ium hydrogen sulfate
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
4-ethylamino-3-nitrobenzoic acid
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
4-hexadecyl-1-phenylpyrazolidin-3-one
430-840-7
202483-63-4
Skin Sens. 1
4-Nonylphenol, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
4-tert-Octylphenol monoethoxylate
621-345-9
2315-67-5
yes
5-bromo-8-naphtholactam
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
5-endo-hexyl-bicyclo[2.2.1]hept-2-ene
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
5-ethoxy-5H-furan-2-one
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
6-glycidyloxynapht-1-yl oxymethyloxirane
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
6-hydroxyindole
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
9-(2-propenyloxy)tricyclo[5.2.1.0(2,6)]dec-3(or-4-)-ene
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
[(1-methyl-1,2-ethanediyl)bis[nitrilobis(methylene)]]tetrakis(phosphonic acid)
421-940-1
28698-31-9
Eye Dam. 1
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