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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 29 april 2024. Database contains 4753 unique substances/entries.
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A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 190°C to 340°C (374°F to 644°F). This stream is likely to contain organic sulfur compounds.
295-991-1
92201-60-0
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 220°C to 450°C (428°F to 842°F). This stream is likely to contain organic sulfur compounds.
295-990-6
92201-59-7
Carc. 1B
Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C.
295-810-6
92129-09-4
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. 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).
295-794-0
92128-94-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
Pyridine bases boiling in the range of approximately 125°C to 160°C (257°F 320°F) obtained by distillation of neutralized acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.
295-548-2
92062-33-4
Carc. 1B; Muta. 1B
The distillation residue remaining after the distillation of the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of coal tars. It contains chiefly aniline, collidines, quinoline and quinoline derivatives and toluidines.
295-544-0
92062-29-8
Carc. 1B; Muta. 1B
The distillation fraction boiling in the range of approximately 181°C to 186°C (356°F to 367°F) from the crude bases obtained from the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of bituminous coal tar. It contains chiefly aniline and collidines.
295-543-5
92062-28-7
Carc. 1B; Muta. 1B
The distillation fraction boiling in the range of approximately 180°C to 200°C (356°F to 392°F) from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar. It contains chiefly aniline, collidines, lutidines and toluidines.
295-541-4
92062-27-6
Carc. 1B; Muta. 1B
A complex combination of organic compounds obtained from brown coal and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). It contains chiefly phenols and pyridine bases.
295-540-9
92062-26-5
Carc. 1B; Muta. 1B
A complex combination of organic compounds obtained from brown coal gasification. Composed primarily of C6-10 hydroxy aromatic phenols and their homologs.
295-536-7
92062-22-1
Carc. 1B; Muta. 1B
Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73°C to 85°C (163°F to 185°F).
295-529-9
92062-15-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
295-523-6
92062-09-4
Carc. 1B
A complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temperature. It boils in the range of approximately 147°C to 300°C (297°F to 572°F) and produces a finished oil having a viscosity of 18cSt at 50°C.
295-517-3
92062-04-9
Carc. 1B
A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C (32°F to 662°F).
295-514-7
92062-00-5
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F).
295-511-0
92061-97-7
Carc. 1B
Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752°F to 846°F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.
295-507-9
92061-94-4
Carc. 1B
The residue from the fractional distillation of wash oil boiling in the approximate range of 270°C to 330°C (518°F to 626°F). It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.
295-506-3
92061-93-3
Carc. 1B
The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340°C to 400°C (644°F to 752°F). It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.
295-505-8
92061-92-2
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons produced by solvent removal of paraffins from the residue of the distillation of acid-treated, hydrocracked heavy paraffins and boiling approximately above 380°C (716°F).
295-499-7
92061-86-4
Carc. 1B
A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidize mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.
295-463-0
92045-80-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained as a semi-solid from dewaxed paraffinic residual oil treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated microcrystalline and liquid hydrocarbons having carbon numbers predominantly greater than C20.
295-459-9
92045-77-7
Carc. 1B
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-455-7
92045-72-2
Carc. 1B
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-454-1
92045-71-1
Carc. 1B
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20°C to 100°C (68°F to 212°F).
295-447-3
92045-65-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by the sorption of benzene from a catalytically fully hydrogenated benzene-rich hydrocarbon cut that was distillatively obtained from prehydrogenated cracked naphtha. It consists predominantly of paraffinic and naphthenic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 70°C to 100°C (158°F to 212°F).
295-446-8
92045-64-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from prehydrogenated cracked naphtha after distillative separation of benzene- and toluene-containing hydrocarbon cuts and a higher boiling fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30°C to 205°C (86°F to 401°F).
295-445-2
92045-63-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C11 and boiling in the range of approximately 130°C to 205°C (266°F to 401°F).
295-444-7
92045-62-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation from the product of a naphtha steam cracking process and subsequent catalytic selective hydrogenation of gum formers. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 230°C (86°F to 446°F).
295-443-1
92045-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 of hydrocarbons having carbon numbers predominantly in the range of C4 through C5, predominantly C5, and boiling in the range of approximately minus 10°C to 35°C (14°F to 95°F).
295-442-6
92045-60-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting naphtha from a catalytic cracking process to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons boiling in a range of approximately 35°C to 210°C (95°F to 410°F).
295-441-0
92045-59-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of a gasoline which has been catalytically isomerized. It consists predominantly of hexane isomers boiling in the range of approximately 60°C to 66°C (140°F to 151°F).
295-440-5
92045-58-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treating a petroleum fraction, derived from a pyrolysis process, with hydrogen in the presence of a catalyst. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 190°C (95°F to 374°F).
295-438-4
92045-57-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94°C to 99°C (201°F to 210°F).
295-436-3
92045-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of hydrodesulfurized and dearomatized light petroleum fractions. It consists predominantly of C7 paraffins and cycloparaffins boiling in a range of approximately 90°C to 100°C (194°F to 212°F).
295-434-2
92045-53-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30°C to 250°C (86°F to 482°F).
295-433-7
92045-52-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
295-432-1
92045-51-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a catalytic cracked petroleum distillate 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 C6 through C12 and boiling in the range of approximately 60°C to 200°C (140°F to 392°F).
295-431-6
92045-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by alkylation of butanes. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12, rich in isooctane, and boiling in the range of approximately 35°C to 210°C (95°F to 410°F).
295-430-0
92045-49-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
295-424-8
92045-43-7
Carc. 1B
295-423-2
92045-42-6
Carc. 1B
A complex combination of hydrocarbons obtained as a wide cut hydrocarbon fuel cut from atmospheric distillation and boiling in the range of approximately 70°C to 220°C (158°F to 428°F).
295-418-5
92045-37-9
Asp. Tox. 1
A complex combination of hydrocarbons obtained from a petroleum stock by solvent refining and sweetening and boiling in the range of approximately 150°C to 260°C (302°F to 500°F).
295-416-4
92045-36-8
Asp. Tox. 1
295-411-7
92045-29-9
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately minus 12°C to 5°C (10.4°F to 41°F).
295-405-4
92045-23-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B

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