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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
Extracts (petroleum), light vacuum gas oil solvent, clay-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.]
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-675-9
100684-05-7
Carc. 1B
Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.]
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-674-3
100684-04-6
Carc. 1B
famoxadone (ISO); 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione
603-520-1
131807-57-3
STOT RE 2
fenaminosulf (ISO); sodium 4-dimethylaminobenzenediazosulphonate
205-419-4
140-56-7
Acute Tox. 3; Acute Tox. 4
fenazaflor (ISO); phenyl 5,6-dichloro-2-trifluor-omethylbenzimidazole-1-carboxylate
238-134-9
14255-88-0
Acute Tox. 4
fenazaquin (ISO);4-[2-[4-(1,1-dimethylethyl)phenyl]-ethoxy]quinazoline
MAGISTER* F ACARICIDAL CHEMICAL
410-580-0
120928-09-8
Acute Tox. 3; Acute Tox. 4
fenbutatin oxide (ISO); bis(tris(2-methyl-2-phenylpropyl)tin)oxide
236-407-7
13356-08-6
Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
fenitrothion (ISO); O, O-dimethyl O-4-nitro-m-tolyl phosphorothioate
204-524-2
122-14-5
Acute Tox. 4
fenpyroximate (ISO); tert-butyl 4-[({(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene]amino}oxy)methyl]benzoate
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
fensulfothion (ISO); O,O-diethyl O-4-methylsulfinylphenyl phosphorothioate
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
ferbam (ISO); iron tris(dimethyldithiocarbamate)
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
flonicamid (ISO); N-(cyanomethyl)-4-(trifluoromethyl)pyridine-3-carboxamide
605-127-0
158062-67-0
Acute Tox. 4
flufenacet (ISO);N-(4-fluorophenyl)-N-isopropyl-2-(5-trifluoromethyl-[1,3,4]thiadiazol-2-yloxy)acetamide
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
flufenoxuron (ISO); 1-(4-(2-cloro-α, α,α-p-trifluorotolyloxy)-2-fluorophenyl)-3-(2,6-difluorobenzolyl)urea
FLUFENOXURON
417-680-3
101463-69-8
Lact.
flumioxazin (ISO); 2-[7-fluoro-3-oxo-4- (prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3 (2H)-dione
600-425-7
103361-09-7
Repr. 1B
fluoroacetic acid
205-631-7
144-49-0
Acute Tox. 2
fluoroboric acid ... %
240-898-3
16872-11-0
Skin Corr. 1B
fluorosilicic acid ... %
241-034-8
16961-83-4
Skin Corr. 1B
fluquinconazole (ISO);3-(2,4-dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4-(3H)-one
FLUQUINCONAZOLE
411-960-9
136426-54-5
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Irrit. 2
folpet (ISO);N-(trichloromethylthio)phthalimide
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
formic acid, nickel salt
239-946-6
15843-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
fumaric acid
203-743-0
110-17-8
Eye Irrit. 2
furan
203-727-3
110-00-9
Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2
yes
gallium arsenide
215-114-8
1303-00-0
Repr. 1B; Carc. 1B; STOT RE 1
Gamma-hexabromocyclododecane
603-804-5
134237-52-8
yes
geraniol; (2E)-3,7-dimethylocta-2,6-dien-1-ol
203-377-1
106-24-1
Skin Sens. 1
glutamic acid, reaction products with N-(C12-14-alkyl)propylenediamine
EW 400; GLUCOPROTAMIN
403-950-8
164907-72-6
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
glutaral; glutaraldehyde; 1,5-pentanedial
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
glyoxal...%; ethandial...%
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
glyphosate (ISO); N-(phosphonomethyl)glycine
213-997-4
1071-83-6
Eye Dam. 1
guazatine (ISO)
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-1-methyl-1H-pyrazole-4-carboxylate
600-130-3
100784-20-1
Repr. 1B
heazlewoodite
-
12035-71-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
heptachlor epoxide; 2,3-epoxy-1,4,5,6,7,8,8-heptachloro-3a,4,7,7a-tetrahydro-4,7-methanoindane
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
heptan-2-one; methyl amyl ketone
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
heptan-3-one; butyl ethyl ketone
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
heptan-4-one; di-n-propyl ketone
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
heptane; n-heptane
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
heptanoic acid
203-838-7
111-14-8
Skin Corr. 1B
hexachloroacetone
204-129-5
116-16-5
Acute Tox. 4
hexachlorobenzene
204-273-9
118-74-1
Carc. 1B; STOT RE 1
hexachloroplatinic acid
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
hexafluoropropene; hexafluoropropylene
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
hexahydro-4-methylphthalic anhydride
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexakis(tetramethylammonium) 4,4'-vinylenebis((3-sulfonato-4,1-phenylene)imino(6- morpholino-1,3,5-triazine-4,2- diyl)imino)bis(5-hydroxy-6-phenylazonaphthalene-2,7- disulfonate)
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
hexamethylene diacrylate; hexane-1,6-diol diacrylate
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hexamethylenediamine
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
hexan-1-ol
203-852-3
111-27-3
Acute Tox. 4
hexane (containing < 5 % n-hexane (203-777-6)); 2-methylpentane
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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