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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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-[(2-[2-(dimethylamino)ethoxy]ethyl)methylamino]ethanol
JEFFCAT ZF-10; TEXACAT ZF-10
406-080-7
83016-70-0
Acute Tox. 4; Skin Corr. 1B
2-[(4-chloro-2-nitrophenyl)amino]ethanol
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
2-[2-(2-butoxyethoxy)ethoxy]ethanol; TEGBE; triethylene glycol monobutylether; butoxytriethylene glycol
205-592-6
143-22-6
Eye Dam. 1
2-[2-(4-nonylphenoxy)ethoxy]ethanol
243-816-4
20427-84-3
yes
2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol
230-770-5
7311-27-5
yes
2-[2-hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one
P-964
420-580-2
151798-26-4
Repr. 1B
2-[3-(methylamino)propyl]-1H-benzimidazole
425-760-4
64137-52-6
Eye Dam. 1
2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol
618-344-0
9002-93-1
yes
2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethanol
687-832-3
1119449-37-4
yes
2-[[4[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazine-2-yl]amino]phenyl]azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutanamide
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1
2-acetoxymethylene-4-acetylphenylacetate
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-alkoyloxyethyl hydrogen maleate, where alkoyl represents (by weight 70 to 85 % unsaturated octadecoyl, 0.5 to 10 % saturated octadecoyl, and 2 to 18 % saturated hexadecoyl
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-amino-2-methylpropanol
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
2-amino-4,6-dinitrophenol; picramic acid;2-amino-4,6-dinitrophenol; picramic acid [≥ 20 % water]
202-544-6
96-91-3
Expl. 1.1; 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-(trifluoromethyl)benzenethiol hydrochloride
429-560-8
4274-38-8
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
2-amino-4-bromo-5-chlorobenzoic acid
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
2-amino-4-chloro-6-methoxypyrimidine
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
2-amino-4-dimethylamino-6-trifluoroethoxy-1,3,5-triazine
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
2-amino-5-methylthiazole
2-AMINO-5-METHYLTHIAZOL
423-800-5
7305-71-7
Acute Tox. 4; STOT RE 2
2-amino-6-ethoxy-4-methylamino-1,3,5-triazine
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
2-aminoethanol; ethanolamine
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
2-aminoethyldimethylamine; 2-dimethylaminoethylamine
203-541-2
108-00-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
2-aminophenol
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
2-aminopropane; isopropylamine
200-860-9
75-31-0
Flam. Liq. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2-aminosulfonyl-N, N-dimethylnicotinamide
DAM 520
413-440-7
112006-75-4
Skin Sens. 1
2-Benzotriazol-2-yl-4,6-di-tert-butylphenol; UV-320
223-346-6
3846-71-7
yes
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
2-benzyl-2-methyl-3-butenitrile
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
2-bromo-1-(2-furyl)-2-nitroethylene
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; 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-4,6-difluoroaniline
429-430-0
444-14-4
Acute Tox. 4
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-bromopropane
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
2-butanone-O, O',O''-(phenylsilylidyne)trioxime
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
2-butoxyethanol; ethyleneglycol monobutyl ether; butyl cellosolve
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-butoxyethyl acetate; butylglycol acetate
203-933-3
112-07-2
Acute Tox. 4
2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one hydrochloride
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
2-butyl-2-ethyl-1,5-diaminopentane
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-butyl-4-chloro-5-formylimidazole
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
2-butyryl-3-hydroxy-5-thiocyclohexan-3-yl-cyclohex-2-en-1-one
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
2-chloracetamide
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
2-chloro-1,3,5-trinitrobenzene
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
2-chloro-3-trifluoromethylpyridine
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-chloro-4,5-difluorobenzoic acid
2-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-chloro-4-(methylsulfonyl)benzoic acid
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
2-chloro-4-fluoro-5-nitrophenyl(isobutyl)carbonate
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-chloro-4-nitroaniline
204-502-2
121-87-9
Acute Tox. 4
2-chloro-5-chloromethylthiazole
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
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