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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
pentasodium 5-anilino-3-(4-(4-(6-chloro-4-(3-sulphonatoanilino)-1,3,5-triazin-2-ylamino)-2,5-dimethylphenylazo)-2,5-disulphonatophenylazo)-4-hydroxynaphthalene-2,7-disulphonate
301-312-2
93983-23-4
Eye Irrit. 2
3-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-(E)-2-propenal
425-370-4
93957-50-7
Skin Sens. 1
trisodium bis(2-(5-chloro-4-nitro-2-oxidophenylazo)-5-sulphonato-1-naphtholato)chromate(1-)
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
Formaldehyde, reaction products with branched and linear heptylphenol, carbon disulfide and hydrazine
300-298-5
93925-00-9
yes
Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate; Baseoil — unspecified
300-257-1
93924-61-9
Carc. 1B
Gas oils, paraffinic; Gasoil — unspecified [A distillate obtained from the redistillation of a complex combination of hydrocarbons obtained by the distillation of the effluents from a severe catalytic hydrotreatment of paraffins. It boils in the range of approximately 190°C to 330°C (374°F to 594°F).]
A distillate obtained from the redistillation of a complex combination of hydrocarbons obtained by the distillation of the effluents from a severe catalytic hydrotreatment of paraffins. It boils in the range of approximately 190°C to 330°C (374°F to 594°F).
300-227-8
93924-33-5
Carc. 1B
Foots oil (petroleum), clay-treated; Foots oil [A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predomi nantly of branched chain hydro carbons with carbon numbers predominantly in the range of C20 through C50.]
A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-226-2
93924-32-4
Flam. Gas 1; Press. Gas; Carc. 1B
Foots oil (petroleum), acid-treated; Foots oil [A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulfuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.]
A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulfuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-225-7
93924-31-3
Flam. Gas 1; Press. Gas; Carc. 1B
nickel(II) neononanoate
300-094-6
93920-10-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel(II) neoundecanoate
300-093-0
93920-09-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Residual oils (petroleum); Heavy Fuel oil [A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2cSt. at 100 °C.]
A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2cSt. at 100°C.
298-754-0
93821-66-0
Carc. 1B
Extract residues (coal), benzole fraction acid; Light Oil Extract Residues, low boiling [n acid sludge by-product of the sulfuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.]
An acid sludge by-product of the sulphuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.
298-725-2
93821-38-6
Carc. 1B; Muta. 1B
Residues (petroleum), steam-cracked heat-soaked naphtha; Cracked gasoil [ complex combination of hydrocarbons obtained as residue from the distillation of steam cracked heat soaked naphtha and boiling in the range of approximately 150 °C to 350 °C (302 °F to 662 °F).]
A complex combination of hydrocarbons obtained as residue from the distillation of steam cracked heat soaked naphtha and boiling in the range of approximately 150°C to 350°C (302°F to 662°F).
297-905-8
93763-85-0
Carc. 1B
Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed; Baseoil — unspecified
297-857-8
93763-38-3
Carc. 1B
Hydrocarbons, C9-16, hydrotreated, dearomatized; Kerosine — unspecified [ complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.]
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-854-1
93763-35-0
Asp. Tox. 1
Hydrocarbons, C9-12, hydrotreated, dearomatized; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.]
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-853-6
93763-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C6-11, hydrotreated, dearomatized; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.]
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-852-0
93763-33-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
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), heavy naphthenic distillate solvent, hydrodesulfurized; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained from a 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 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.
297-827-4
93763-10-1
Carc. 1B
2,5-dibutoxy-4-(morpholin-4-yl)benzenediazonium 4-methylbenzenesulfonate
DIAZO W 6623-TS
413-290-2
93672-52-7
Self-react. C; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3-(N-methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol hydrochloride
IMEXINE FAE
403-440-5
93633-79-5
Acute Tox. 4
1,3-bis(vinylsulfonylacetamido)propane
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
Lubricating oils (petroleum), base oils, paraffinic; Baseoil — unspecified [ complex combination of hydrocarbons obtained by refining of crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 120 SUS at 100 °F (23cSt at 40 °C).]
A complex combination of hydrocarbons obtained by refining of crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 120 SUS at 100°F (23cSt at 40°C).
297-474-6
93572-43-1
Carc. 1B
Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35 °C to 125 °C (94°F to 257°F), benzene and toluene.]
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 125°C (94°F to 257°F), benzene and toluene.
297-466-2
93572-36-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C7-12, C≥9-arom.-rich, reforming heavy fraction; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 120 °C to 210 °C (248°F to380°F) and C9 and higher aromatic hydrocarbons.]
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 120°C to 210°C (248°F to 380°F) and C9 and higher aromatic hydrocarbons.
297-465-7
93572-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gasoline, C5-11, high-octane stabilised reformed; Low boiling point cat-reformed naphtha; - [ complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approxi mately 45 °C to 185 °C (113°F to 365 °F).]
A complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 45°C to 185°C (113°F to 365°F).
297-458-9
93572-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Aromatic hydrocarbons, C7-12, C8-rich; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130 °C to 200 °C (266°F to 392°F).]
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C (266°F to 392°F).
297-401-8
93571-75-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
cis-1,2,3,6-tetrahydrophthalicanhydride
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
vanadium(IV) oxide hydrogen phosphate hemihydrate, lithium, zinc, molybdenum, iron and chlorine-doped
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
Naphtha (petroleum), light steam-cracked, hydrogenated; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons produced from the separation and subsequent Hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately 50o C to 200o C (122 °F to 392 °F). The proportion of benzene hydrocarbons may vary up to 30 wt. % and the stream may also contain small amounts ofsulfur and oxygenated compounds.]
A complex combination of hydrocarbons produced from the separation and subsequent hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately 50°C to 200°C (122°F to 392°F). The proportion of benzene hydrocarbons may vary up to 30 wt. % and the stream may also contain small amounts of sulphur and oxygenated compounds.
296-942-7
93165-55-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), C6-rich; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C5 through C7, rich in C6, and boiling in the range of approximately 60o C to70o C (140 °F to 158 °F).]
A complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C5 through C7, rich in C6, and boiling in the range of approximately 60°C to 70°C (140°F to 158°F).
296-903-4
93165-19-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
1-cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
3-(2-chloroethyl)-6,7,8,9-tetra-hydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one monohydrochloride
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2,4,5-T (ISO); 2,4,5-trichlorophenoxy acetic acid
202-273-3
93-76-5
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
thioquinox(ISO); 2-thio-1,3-dithiolo(4,5,b)quinoxaline
202-272-8
93-75-4
Acute Tox. 4
fenoprop (ISO); 2-(2,4,5-trichlorophenoxy)propionic acid
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
allidochlor (ISO); N,N-diallylchloroacetamide
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
4-amino-N,N-diethylaniline; N,N-diethyl-p-phenylendiamine
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
4-[(3-hydroxypropyl)amino]-3-nitrophenol
PLAKATROT Z; ROT BN
406-305-9
92952-81-3
Skin Irrit. 2
1-(2,3-dihydro-1,3,3,6-tetramethyl-1-(1-methylethyl)-1H-inden-5-yl)ethanone
ACYLINDANE
411-180-9
92836-10-7
Acute Tox. 4; STOT RE 2
4-[4-(2,2-dimethyl-propanamido)]phenylazo-3-(2-chloro-5-(2-(3-pentadecylphenoxy)butylamido)anilino)-1-(2,4,6-trichlorophenyl)-2-pyrazoline-5-one
420-220-4
92771-56-7
Skin Sens. 1
(E-E)-3,3'-(1,4-phenylenedimethylidene)bis(2-oxobornane-10-sulfonic acid)
MEXORYL SX; SX 32
410-960-6
92761-26-7
Eye Dam. 1
Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt.% or more 4-6 membered ring aromatic hydrocarbons.]
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more 4-6 membered ring aromatic hydrocarbons.
296-437-1
92704-08-0
Carc. 1B
2-methyl-4-phenylpentanol
PAMPLEFLEUR
402-770-7
92585-24-5
Skin Sens. 1
disodium N-carboxymethyl-N-(2-(2-hydroxyethoxy)ethyl)glycinate
DIDA
402-360-8
92511-22-3
Eye Dam. 1
sodium 3-(2H-benzotriazol-2- yl)-5-sec-butyl-4-hydroxyben zenesulfonate
BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
403-080-9
92484-48-5
Eye Dam. 1
sec-butyl nitrite
213-104-8
924-43-6
Flam. Liq. 2; Acute Tox. 4
N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
2-hydroxypropyl methacrylate
213-090-3
923-26-2
Eye Irrit. 2; Skin Sens. 1
Naphtha (petroleum), light heat-soaked, steam-cracked; Low boiling point naphtha — unspecified [ complex combination of hydrocarbons obtained by the fractionation of steam cracked naphtha after recovery from a heat soaking process. It consists predominantly of hydrocarbons having a carbon number predominantly in the range of C4 through C6 and boiling in the range of approxi mately 0o C to 80o C (32°F to 176°F).]
A complex combination of hydrocarbons obtained by the fractionation of steam cracked naphtha after recovery from a heat soaking process. It consists predominantly of hydrocarbons having a carbon number predominantly in the range of C4 through C6 and boiling in the range of approximately 0°C to 80°C (32°F to 176°F).
296-028-8
92201-97-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
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