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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
Residues (petroleum), vacuum, light; Heavy Fuel oil [A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390 °C (734 °F).]
A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390°C (734°F).
292-658-2
90669-76-4
Carc. 1B
Residues, steam cracked, thermally treated; Heavy Fuel oil [A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).]
A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
308-733-0
98219-64-8
Carc. 1B
S-(chlorophenylthiomethyl) O,O-dimethylphosphorodithioate; methylcarbophenothione
-
953-17-3
Acute Tox. 3
safrole; 5-allyl-1,3-benzodioxole
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
sec-butyl nitrite
213-104-8
924-43-6
Flam. Liq. 2; Acute Tox. 4
Slack wax (petroleum), acid-treated; Slack wax [A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulfuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulfuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
292-659-8
90669-77-5
Carc. 1B
Slack wax (petroleum), clay-treated; Slack wax [A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predomi nantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.
292-660-3
90669-78-6
Carc. 1B
Slack wax (petroleum), hydrotreated; Slack wax [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.]
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
Slack wax (petroleum), low-melting, carbon-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-155-9
97863-04-2
Carc. 1B
Slack wax (petroleum), low-melting, clay-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impur ities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-156-4
97863-05-3
Carc. 1B
Slack wax (petroleum), low-melting, hydrotreated; Slack wax [A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predomi nantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
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
Slack wax (petroleum), low-melting, silicic acid-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-158-5
97863-06-4
Carc. 1B
Slack wax (petroleum), low-melting; Slack wax [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.]
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
slimes and sludges, copper electrolyte refining, decopperised
Substance obtained as a powdery cathodic precipitate during the electrolytic decoppering stage of copper refining electrolysis. Consists primarily of copper with antimony, arsenic, lead and nickel in metallic form as well as oxides and sulfates.
305-433-1
94551-87-8
Carc. 1A; Muta. 2; Repr. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
slimes and sludges, copper electrolytic refining, decopperised, nickel sulfate
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
sodium 2-(nonanoyloxy)benzenesulfonate
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 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
sodium 4-(2,4,4-trimethylpentylcarbonyloxy)benzenesulfonate
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
sodium cyanate
213-030-6
917-61-3
Acute Tox. 4
Solvent naphtha (petroleum), hydrotreated light naphthenic; Low boiling point hydrogen treated naphtha [ 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 approxi mately 73o C to 85o C (163 °F to 185 °F).]
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
styrene oxide;(epoxyethyl)benzene; phenyloxirane
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
subtilisin
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
sulcotrione (ISO); 2-[2-chloro-4-(methylsulfonyl)benzoyl]cyclohexane-1,3-dione
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
sulfallate (ISO); 2-chloroallyl N, N-dimethyldithiocarbamate
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
sulfoxaflor (ISO); [methyl(oxo) {1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide
807-366-8
946578-00-3
Acute Tox. 4
Tar acids, brown-coal, C2-alkylphenol fraction; Distillate Phenols [he distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200 °C to 230 °C (392°F to 446°F). Composed primarily of m-and p-ethylphenol as well as cresols and xylenols.]
The distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Composed primarily of m- and p-ethylphenol as well as cresols and xylenols.
302-662-9
94114-29-1
Carc. 1B; Muta. 1B
Tar acids, browncoal gasification; Crude Phenols [ complex combination of organic compounds obtained from brown coal gasification. Composed primarily of C6-10 hydroxy aromatic phenols and their homologs.]
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
Tar acids, cresylic; Distillate Phenols [ 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.]
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
Tar acids, distn. residues; Distillate Phenols [ residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60 °C to 80 °C (140°F to 176°F).]
A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60°C to 80°C (140°F to 176°F).
306-251-5
96690-55-0
Carc. 1B; Muta. 1B
Tar bases, coal, aniline fraction; Distillate Bases [The distillation fraction boiling in the range of approximately 180o C to 200o C (356 oF to 392 oF) 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.]
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
Tar bases, coal, collidine fraction; Distillate Bases [The distillation fraction boiling in the range of approximately 181 o C to 186 o C (356 oF to 367 oF) 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.]
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
Tar bases, coal, distn. residues; Distillate Bases [he distillation residue remaining after the distillation of the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of oal tars. I contains chiefly aniline, collidines, quinoline and quinoline derivatives and toluidines.]
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
Tar bases, coal, lutidine fraction; Distillate Bases
293-766-2
91082-52-9
Carc. 1B; Muta. 1B
Tar bases, coal, picoline fraction; Distillate Bases [Pyridine bases boiling in the range of approximately 125o C to 160o C (257oF 320oF) 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.]
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
Tar bases, coal, toluidine fraction; Distillate Bases
293-767-8
91082-53-0
Carc. 1B; Muta. 1B
Tar oils, brown-coal; Light Oil [The distillate from lignite tar boiling in the range of approximately 80 °C to 250 °C (176°F to 482 °F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.]
The distillate from lignite tar boiling in the range of approximately 80°C to 250°C (176°F to 482°F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.
302-674-4
94114-40-6
Carc. 1B; Muta. 1B
Tar, coal, high-temp., distn. and storage residues; Coal Tar Solids Residue [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.]
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
Tar, coal, storage residues; Coal Tar Solids Residue [The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.]
The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
293-764-1
91082-50-7
Carc. 1B
tetrahydro-2-furyl-methanol; tetrahydrofurfuryl alcohol
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
tetrakis(1,2,2,6,6-pentamethyl-4-piperidyl)-1,2,3,4-butanetetracarboxylate
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
tetramethylthiuram monosulphide
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
tetrasodium 2-(6-chloro-4-(4-(2,5-dimethyl-4-(2,5-disulphonatophenylazo)phenylazo)-3-ureidoanilino)-1,3,5-triazin-2-ylamino)benzene-1,4-disulphonate
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
thioquinox(ISO); 2-thio-1,3-dithiolo(4,5,b)quinoxaline
202-272-8
93-75-4
Acute Tox. 4
trans-4-cyclohexyl-L-proline monohydrochloride
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
trans-4-phenyl-L-proline
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
trichloromethylstannane
213-608-8
993-16-8
Repr. 2
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
trypsin
232-650-8
9002-07-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. 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
Waste solids, coal-tar pitch coking; Coal Tar Solids Residue [The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.]
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
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