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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained as the extract from a solvent extraction of heavy paraffinic distillate.]
A complex combination of hydrocarbons obtained as the extract from a solvent extraction of heavy paraffinic distillate.
272-342-0
68814-89-1
Carc. 1B
Gases (petroleum), refinery; Refinery gas [ complex combination obtained from various petroleum refining operations. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.]
A complex combination obtained from various petroleum refining operations. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
272-338-9
68814-67-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Silicic acid (H2Si2O5), barium salt (1:1), lead-doped
272-271-5
68784-75-8
yes
constitutional isomers of penta-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hexa-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hepta-O-allyl-β-D-fructofuransoyl-α-D-glucopyranoside
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Naphtha (petroleum), light, sweetened; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydro carbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately - 20o C to 100o C (- 4°F to 212 °F).]
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -20°C to 100°C (-4°F to 212°F).
272-206-0
68783-66-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gases (petroleum), C2-4, sweetened; Petroleum gas [ complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C2 through C4 and boiling in the range of approximately - 51 °C to - 34 °C (- 60°F to - 30°F).]
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C2 through C4 and boiling in the range of approximately -51°C to -34°C (-60°F to -30°F).
272-205-5
68783-65-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), catalytic cracking; Petroleum gas [ complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C3 through C5.]
A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C3 through C5.
272-203-4
68783-64-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Residues(petroleum), coker scrubber, Condensed-ring-arom.-contg.; Heavy Fuel oil [A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vaccum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C (662 °F). This stream is likely to contain 5 wt.% or more of 4-to 6-membered condensed rind aromatic hydrocarbons.]
A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
272-187-9
68783-13-1
Carc. 1B
Naphtha (petroleum), unsweetened; Low boiling point naphtha [ complex combination of hydrocarbons produced from the distillation of naphtha streams from various refinery processes. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 0 °C to 230 °C (25°F to 446°F).]
A complex combination of hydrocarbons produced from the distillation of naphtha streams from various refinery processes. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 0°C to 230°C (25°F to 446°F).
272-186-3
68783-12-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), catalytic cracked light distd.; Low boiling point cat-cracked naphtha [ complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-185-8
68783-09-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gas oils (petroleum), heavy atmospheric; Heavy Fuel oil [A complex combination of hydrocarbons obtained by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C35 and boiling in the range of approximately 121°C to 510 °C (250 °F to 950°F).]
A complex combination of hydrocarbons obtained by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C35 and boiling in the range of approximately 121°C to 510°C (250°F to 950°F).
272-184-2
68783-08-4
Carc. 1B
Gases (petroleum), refinery blend; Petroleum gas [ complex combination obtained from various processes.; It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination obtained from various refinery processes. It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-183-7
68783-07-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), hydrocracking low-pressure separator; Refinery gas [ complex combination obtained by the liquid-vapor separation of the hydrocracking process reactor effluent. It consists predominantly of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C3.]
A complex combination obtained by the liquid-vapor separation of the hydrocracking process reactor effluent. It consists predominantly of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
272-182-1
68783-06-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 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), heavy naphthenic distillate solvent, arom. conc.; Distillate aromatic extract (treated) [n aromatic concentrate produced by adding water to heavy naphthenic distillate solvent extract and extraction solvent.]
An aromatic concentrate produced by adding water to heavy naphthenic distillate solvent extract and extraction solvent.
272-175-3
68783-00-6
Carc. 1B
trans-1-methyl-4-(1-methylvinyl)cyclohexene
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
ethyl (S)-2-hydroxypropionate; ethyl L-lactate; ethyl-(S)-lactate
211-694-1
687-47-8
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1-(1H-imidazol-1-yl)-2-propoxyethanimine
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
272-013-1
68648-93-1
yes
2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
1,2-dihydro-6-hydroxy-4-methyl-1-[3-(1-methylethoxy)propyl]-2-oxo-3-pyridinecarbonitrile
FAT 92'364/A
411-990-2
68612-94-2
Skin Sens. 1
nickel barium titanium primrose priderite; C.I. Pigment Yellow 157; C.I. 77900
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77900.
271-853-6
68610-24-2
Carc. 1A; STOT RE 1; Skin Sens. 1
oxirane, mono[(C12-14-alkyloxy)methyl] derivs.
271-846-8
68609-97-2
Skin Irrit. 2; Skin Sens. 1
Residues (petroleum), topping plant, low-sulfur; Heavy Fuel oil [A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.]
A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.
271-763-7
68607-30-7
Carc. 1B
Petroleum products, refinery gases; Refinery gas [ complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.]
A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.
271-750-6
68607-11-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), depropanizer bottoms fractionation off; Petroleum gas [ complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists predominantly of butane, isobutane and butadiene.]
A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists predominantly of butane, isobutane and butadiene.
271-742-2
68606-34-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), alkylation feed; Petroleum gas [ complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C4.]
A complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C4.
271-737-5
68606-27-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Hydrocarbons, C3; Petroleum gas
271-735-4
68606-26-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Hydrocarbons, C2-4; Petroleum gas
271-734-9
68606-25-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gasoline, straight-run, topping-plant; Low boiling point naphtha [ complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36,1 °C to 193,3 °C (97°F to 380°F).]
A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36.1°C to 193.3°C (97°F to 380°F).
271-727-0
68606-11-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gasoline, pyrolysis, debutanizer bottoms; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.]
A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.
271-726-5
68606-10-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), arom.-contg.; Low boilingpoint naphtha — unspecified
271-635-0
68603-08-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), thermal cracked naphtha and gas oil, extractive; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predomi nantly isoamylenes such as 2-methyl-1-buteneand 2-methyl-2-butene and boiling in the rangeof approximately 31o C to 40o C (88°F to 104°F).]
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predominantly isoamylenes such as 2-methyl-1-butene and 2-methyl-2-butene and boiling in the range of approximately 31°C to 40°C (88°F to 104°F).
271-634-5
68603-03-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg.; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33o C to 184 o C (91°F to 363 °F).]
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33°C to 184°C (91°F to 363°F).
271-632-4
68603-01-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), thermal cracked naphtha and gas oil; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approxi mately 33 o C to 60 o C (91 °F to 140 °F).]
A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approximately 33°C to 60°C (91°F to 140°F).
271-631-9
68603-00-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gases (petroleum), secondary absorber off, fluidized catalytic cracker overheads fractionator; Refinery gas [ complex combination produced by the fractionation of the overhead products from the catalyticcracking process in the fluidized catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.]
A complex combination produced by the fractionation of the overhead products from the catalytic cracking process in the fluidized catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
271-625-6
68602-84-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), C1-5, wet; Petroleum gas [ complex combination of hydrocarbons produced by the distillation of crude oil and/or the cracking of tower gas oil.; It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination of hydrocarbons produced by the distillation of crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
271-624-0
68602-83-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), benzene unit hydrotreater depentanizer overheads; Refinery gas [ complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanizing. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene.]
A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanizing. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene.
271-623-5
68602-82-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Salmonella typhimurium
-
68583-35-7
B Bacteria and similar species
Pseudomonas aeruginosa
-
68583-29-9
B Bacteria and similar species
Corynebacterium pseudotuberculosis
-
68583-16-4
B Bacteria and similar species
Tar acids, cresylic, residues; Distillate Phenols [he residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80 °C (176°F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts.]
The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80°C (176°F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts.
271-418-0
68555-24-8
Carc. 1B; Muta. 1B
Fuel oil, No 6; Heavy Fuel oil [A distillate oil having a minimum viscosity of 900 SUS at 37.7 °C (100 °F) to a maximum of 9000 SUS at 37.7 °C (100 °F).]
A distillate oil having a minimum viscosity of 900 SUS at 37.7°C (100°F) to a maximum of 9000 SUS at 37.7°C (100°F).
271-384-7
68553-00-4
Carc. 1B
Naphtha (petroleum), full-range alkylate, butane-contg.; Low boiling point modified naphta [ complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 with some butanes and boiling in the range of approximately 35 °C to 200 °C (95 °F to 428 °F).]
A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 with some butanes and boiling in the range of approximately 35°C to 200°C (95°F to 428°F).
271-267-0
68527-27-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum),light steam-cracked, debenzenized; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80o C to 218o C (176°F to 424°F).]
A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80°C to 218°C (176°F to 424°F).
271-266-5
68527-26-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), light steam-cracked arom.; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9 and boiling in the range of approximately 110o C to 165 o C (230 °F to 329 °F).]
A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9 and boiling in the range of approximately 110°C to 165°C (230°F to 329°F).
271-264-4
68527-23-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), clay-treated light straight-run; Low boiling point naphtha — unspecified [ complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 93 °C to 180 °C (200°F to 356°F).]
A complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 93°C to 180°C (200°F to 356°F).
271-263-9
68527-22-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), clay-treated full-range straight-run; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons resulting from treatment of full-range straight- run naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately - 20o C to 220o C (- 4°F to 429°F).]
A complex combination of hydrocarbons resulting from treatment of full-range straight-run naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately -20°C to 220°C (-4°F to 429°F).
271-262-3
68527-21-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C1-4, debutanizer fraction; Petroleum gas
271-261-8
68527-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gas oils (petroleum), steam-cracked; Cracked gasoil [ complex combination of hydrocarbons produced by distillation of the products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C9 and boiling in the range of from approximately 205 °C to 400 °C (400 °F to 752 °F).]
A complex combination of hydrocarbons produced by distillation of the products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C9 and boiling in the range of from approximately 205°C to 400°C (400°F to 752°F)
271-260-2
68527-18-4
Carc. 1B
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