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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 paraffinic distillate solvent
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-104-2
64742-05-8
Carc. 1B
Extracts (petroleum), light paraffinic distillate solvent, carbon-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.]
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
Extracts (petroleum), light paraffinic distillate solvent, clay-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.]
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B
Extracts (petroleum), light paraffinic distillate solvent, hydrodesulfurized; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained by solvent extraction of a light paraffin distillate and treated with hydrogen to convert the organic sulfur to hydrogen sulfide which is eliminated. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C40 and produces a finished oil with a viscosity of greater than 10cSt at 40 °C.]
A complex combination of hydrocarbons obtained by solvent extraction of a light paraffin distillate and treated with hydrogen to convert the organic sulfur to hydrogen sulfide which is eliminated. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C40 and produces a finished oil with a viscosity of greater than 10cSt at 40°C.
295-340-1
91995-77-6
Carc. 1B
Extracts (petroleum), light paraffinic distillate solvent, hydrotreated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons produced by treating a lightparaffinic distillate solvent extract with hydrogen in the presence of acatalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C26 and boiling in the range of approximately 280°C to 400°C (536 °F to 752 °F).]
A complex combination of hydrocarbons produced by treating a light paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C26 and boiling in the range of approximately 280° to 400°C (536°F to 752°F).
292-633-6
90641-09-1
Carc. 1B
Extracts (petroleum), light vacuum gas oil solvent
A complex combination of hydrocarbons obtained by solvent extraction from light vacuum petroleum gas oil. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-341-7
91995-78-7
Carc. 1B
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, hydrotreated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons, obtained by solvent extraction from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. 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 from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-342-2
91995-79-8
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
Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurized; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40 °C.]
A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C.
297-829-5
93763-11-2
Carc. 1B
Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent; Distillate aromaticextract (treated) [ complex combination of hydrocarbons obtained as the extractfrom the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.]
A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
272-180-0
68783-04-0
Carc. 1B
Extracts(petroleum), light paraffinic distillate solvent, acid-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulfuric acid refining. It consists predomi nantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.]
A complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulfuric acid refining. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
295-339-6
91995-76-5
Carc. 1B
Extracts, coal tar oil alk.; Alkaline Extract [he extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
266-017-2
65996-83-0
Carc. 1B; Muta. 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
Fasciola gigantica
-
-
P Parasites
Fasciola hepatica
-
-
P Parasites
Fasciolopsis buski
-
-
P Parasites
fatty acids, C 8-18 and C18-unsaturated, nickel salts
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
fatty acids, C18-unsatd., dimers, reaction products with 1-piperazineethanamine and tall oil
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
fatty acids, C6-19-branched, nickel salts
294-302-1
91697-41-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
fatty acids, tall-oil, reaction products with iminodiethanol and boric acid
294-785-9
91770-03-5
Skin Irrit. 2
fenaminosulf (ISO); sodium 4-dimethylaminobenzenediazosulphonate
205-419-4
140-56-7
Acute Tox. 3; Acute Tox. 4
fenamiphos (ISO); ethyl-4-methylthio-m-tolyl isopropyl phosphoramidate
244-848-1
22224-92-6
Acute Tox. 2; Eye Irrit. 2
fenarimol (ISO); 2,4'-dichloro-α-(pyrimidin-5-yl)benzhydryl alcohol
262-095-7
60168-88-9
Repr. 2; Lact.
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
fenchlorphos (ISO); O, O-dimethyl O-2,4,5-trichlorophenyl phosphorothioate
206-082-6
299-84-3
Acute Tox. 4
fenitrothion (ISO); O, O-dimethyl O-4-nitro-m-tolyl phosphorothioate
204-524-2
122-14-5
Acute Tox. 4
fenobucarb (ISO); 2-butylphenyl methylcarbamate
223-188-8
3766-81-2
Acute Tox. 4
fenoprop (ISO); 2-(2,4,5-trichlorophenoxy)propionic acid
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
fenoxaprop-P-ethyl (ISO); ethyl (2R)-2-{4-[(6-chloro-1,3-benzoxazol-2-yl)oxy]phenoxy}propanoate
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
fenoxycarb (ISO); ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
276-696-7
72490-01-8
Carc. 2
fenpropathrin (ISO); α-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate
254-485-0
39515-41-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
fenpropimorph (ISO);cis-4-[3-(p-tert-butylphenyl)-2- methylpropyl]-2,6-dimethylmorpholine
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
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
fenson (ISO); 4-chlorophenyl benzenesulphonate
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
fensulfothion (ISO); O,O-diethyl O-4-methylsulfinylphenyl phosphorothioate
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
fenthion (ISO); O, O-dimethyl-O-(4-methylthion-m-tolyl) phosphorothioate
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
fentin acetate (ISO); triphenyltin acetate
212-984-0
900-95-8
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
fentin hydroxide (ISO); triphenyltin hydroxide
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
ferbam (ISO); iron tris(dimethyldithiocarbamate)
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
ficin
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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
Flavobacterium meningosepticum
-
-
B Bacteria and similar species
Flexal virus
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
flocoumafen (ISO); reaction mass of: cis-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin; trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; STOT RE 1
flonicamid (ISO); N-(cyanomethyl)-4-(trifluoromethyl)pyridine-3-carboxamide
605-127-0
158062-67-0
Acute Tox. 4
fluazifop-butyl (ISO); butyl (RS)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
274-125-6
69806-50-4
Repr. 1B
fluazifop-P-butyl (ISO); butyl (R)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
616-669-2
79241-46-6
Repr. 2
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