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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
N, N,N',N'-tetramethyldithiobis(ethylene)diamine dihydrochloride
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
N, N,N',N'-tetramethylethylenediamine
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
N, N-bis(2-(p-toluenesulfonyloxy)ethyl)-p-toluenesulfonamide
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
N, N-bis(3-aminopropyl)methylamine
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
N, N-dibutyl-(2,5-dihydro-5-thioxo-1H-tetrazol-1-yl)acetamide
418-290-6
168612-06-4
Eye Irrit. 2; Skin Sens. 1
N, N-dimethyl-2-(3-(4-chloro phenyl)-4,5-dihydropyrazol-1- ylphenylsulphonyl)ethylamine
HOSTALUX VP 3481
401-410-6
10357-99-0
STOT RE 2; Skin Sens. 1
N, N-dimethylanilinium tetrakis(pentafluorophenyl)borate
B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM
422-050-6
118612-00-3
Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
N, N-hydrazinodiacetic acid
F.H.D.A.
403-510-5
19247-05-3
Acute Tox. 3; STOT RE 2; Skin Sens. 1
N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid-5-hydroxynapht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)ethane-1,2-diamine, sodium salt
RED REN 363
419-500-9
171599-85-2
Eye Dam. 1; Skin Sens. 1
N,N'-dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
N,N'—1,6-hexanediylbis(N-(2,2,6,6-tetramethyl-piperidin-4-yl)-formamide
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
Eye Irrit. 2
N,N,N',N'-tetraglycidyl-4,4'-diamino-3,3'-diethyldiphenylmethane
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
N,N,N',N'-tetramethyl-4,4'-methylendianiline
202-959-2
101-61-1
Carc. 1B
yes
N,N,N,N-tetrakis(4,6-bis(butyl- (N-methyl-2,2,6,6-tetramethyl piperidin-4-yl)amino)triazin-2- yl)-4,7-diazadecane-1,10- diamine
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
Skin Sens. 1
N,N,N-trimethylanilinium chloride
205-319-0
138-24-9
Acute Tox. 3
N,N-bis(cocoyl-2-oxypropyl)-N,N-dibutylammonium bromide
431-530-4
1380226-29-8
Skin Corr. 1A; Skin Sens. 1
N,N-diethyl-m-toluamide; deet
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
N,N-dimethyl-m-toluidine
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
N,N-dimethylacetamide
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
N,N-dimethylaniline
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
N-(2,2,6,6-tetramethyl-1-oxylpiperidin-4-yl)acetamide; (4-acetamido-2,2,6,6-tetra; methyl-1-piperidinyl)oxidanyl
423-840-3
14691-89-5
Acute Tox. 4
N-(2-(6-ethyl-7-(4-methylphenoxy)-1H-pyrazolo[1,5-b][1,2,4]triazol-2-yl)propyl)-2-octadecyloxybenzamide
UM-229
407-070-5
142859-67-4
Skin Sens. 1
N-(2-amino-4,6-dichloropyrimidin-5-yl)formamide
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
N-(4-(3-(4-cyanophenyl)ureido)-3-hydroxyphenyl)-2-(2,4-di-tert-pentylphenoxy)octanamide
UC-129
403-790-9
108673-51-4
Skin Sens. 1
N-(5-chloro-3-((4-(diethylamino)-2-methylphenyl)imino-4-methyl-6-oxo-1,4-cyclohexadien-1-yl)benzamide
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
N-2-naphthylaniline; N-phenyl-2-naphthylamine
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
N-[(benzotriazole-1-yl)methyl)]4-carboxy-benzenesulfonamide
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
N-[2-hydroxy-3-(C12-16-alkyloxy)propyl]-N-methyl glycinate
DS 100
415-060-7
1379678-87-1
Eye Dam. 1; Skin Sens. 1
N-[3-(1,1-dimethylethyl)-1H-pyrazol-5-yl]-N'-hydroxy-4-nitrobenzenecarboximidamide
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
N-benzyl-N-ethyl-(4-(5-nitro-benzo[c]isothiazol-3-ylazo)phenyl)amine
425-300-2
186450-73-7
Skin Sens. 1
n-butyl acetate
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
n-butyl acrylate
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
N-butyl-2-(4-morpholinylcarbonyl)benzamide
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
n-butyronitrile
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
N-cyclohexyl-S, S-dioxo; benzo[b]tiophene-2-carboxamide
PREVENTOL VP OC 3061
423-990-1
149118-66-1
Acute Tox. 4; Eye Dam. 1
N-dodecyl-[3-(4-(dimethylamino)benzamido)-propyl]dimethylammonium tosylate
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
N-ethylaniline
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
n-hexane
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
N-isopropyl-N'-phenyl-p-phenylenediamine
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
N-methyl-N-cyanomethylmorpholiniummethylsulfate
429-340-1
186295-11-4
Acute Tox. 4; Eye Dam. 1
N-methylaniline
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
N-methylformamide
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
N-nitro-N-(3-methyl-3,6-dihydro-2H-1,3,5-oxadiazin-4-yl)amine
431-060-1
153719-38-1
Acute Tox. 4; Skin Sens. 1
N2,N4,N6-tris{4-[(1,4-dimethylpentyl)amino]phenyl}-1,3,5-triazine-2,4,6-triamine
426-150-0
121246-28-4
Skin Sens. 1
nabam (ISO); disodium ethylenebis(N, N'-dithiocarbamate)
205-547-0
142-59-6
Acute Tox. 4; STOT SE 3; Skin Sens. 1
Naphtha (petroleum), heavy straight run, arom.-contg.; Low boiling point naphtha [ complex combination of hydrocarbons obtained from a distillation process of crude petroleum. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130 °C to 210 °C (266°F to 410°F).]
A complex combination of hydrocarbons obtained from a distillation process of crude petroleum. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
309-945-6
101631-20-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), hydrodesulfurised full-range coker; Low boiling point naphtha -unspecified [ complex ombination of hydrocarbons obtained by fractionation from hydrodesulfurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23 °C to 196 °C (73 °F to 385 °F).]
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23°C to 196°C (73°F to 385°F).
309-879-8
101316-76-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), sweetened light; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 20 o C to 130 o C (68 °F to 266 °F).]
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 20°C to 130°C (68°F to 266°F).
309-976-5
101795-01-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
naphthenic acids, copper salts; copper naphthenate
215-657-0
1338-02-9
Flam. Liq. 3; Acute Tox. 4
naptalam-sodium (ISO); sodium N-naphth-1-ylphthalamate
205-073-4
132-67-2
Acute Tox. 4
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