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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
metaflumizone (ISO); (EZ)-2-[2-(4-cyanophe-nyl)-1-(a,a,a -trifluoro-m-tolyl)ethylidene]-[4-(tri-fluoromethoxy)phenyl] carbanilohydrazide [E-iso-mer > 90 %, Z-isomer <10 % relative content]; [1] (E)-2-[2-(4-cyanophenyl)-1-(a,a,a -trifluoro-m-tolyl) ethylidene]-[4-(trifluoro-methoxy)phenyl]carbani-lohydrazide [2]
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
(isodecanoato-O)(isooctanoato-O)nickel
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
disodium 1-amino-4-(4-benzenesulphonamido-3-sulphonatoanilino)anthraquinone-2-sulphonate
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
hexasodium 6,13-dichloro-3,10- bis((4-(2,5-disulfonatoanilino)-6- fluoro-1,3,5-triazin-2- ylamino)prop-3-ylamino)-5,12- dioxa-7,14-diazapentacene-4,11- disulfonate
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
6-hydroxy-1-(3-isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
2-ethylhexanoato-O)(neodecanoato-O)nickel
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Gas oils (petroleum), hydrodesulfurized coker heavy vacuum; Heavy Fuel oil [A complex combination of hydrocarbons obtained by hydrodesulfurization of heavy coker distillate stocks, It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C18 to C44 and boiling in the range of approximately 304°C to 548°C (579°F to 1018°F). Likely to contain 5 % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons obtained by hydrodesulfurization of heavy coker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C18 to C44 and boiling in the range of approximately 304°C to 548°C (579°F to 1018° F). Likely to contain 5% or more of 4- to 6- membered condensed ring aromatic hydrocarbons.
285-555-9
85117-03-9
Carc. 1B
Naphtha (petroleum), hydrotreated light, cycloalkane-contg.; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained from the distillation of a petroleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately - 20°C to 190 °C (- 4°F to 374°F).]
A complex combination of hydrocarbons obtained from the distillation of a petroleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F).
285-512-4
85116-61-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), hydrodesulfurized thermal cracked light; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained by fractionation of hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23 °C to 195 °C (73°F to 383°F).]
A complex combination of hydrocarbons obtained by fractionation of hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23°C to 195°C (73°F to 383°F).
285-511-9
85116-60-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), catalytic reformed light, arom.-free fraction; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66o C to 121o C (151°F to250°F).]
A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66°C to 121°C (151°F to 250°F).
285-510-3
85116-59-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), catalytic reformed hydrotreated light, C8-12 arom. fraction;-Low boiling point cat-reformed naphtha [ complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160 °C to 180 °C (320°F to 356°F).]
A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160°C to 180°C (320°F to 356°F).
285-509-8
85116-58-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), catalytic reformed hydrodesulfurized heavy, arom. fraction; Kerosine — unspecified [ complex combination of hydrocarbons produced by fractionation from catalytically reformed hydrodesulfurized naphtha. It consists predominantly of aromatic hydrocarbons having carbon numbers predominently in the range of C7 to C 13 and boiling in the range of approximately 98°C to 218°C (208°F to 424°F).]
A complex combination of hydrocarbons produced by fractionation from catalytically reformed hydrodesulfurized naphtha. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 to C13 and boiling in the range of approximately 98°C to 218°C (208°F to 424°F).
285-508-2
85116-57-0
Asp. Tox. 1
Kerosine (petroleum), hydrodesulfurized thermal cracked; Cracked kerosine [ complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate. It consists predomi nantly of hydrocarbons predominantly in the range of C8 to C16 and boiling in the range of approximately 120°C to 283°C (284°F to 541°F).]
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons predominantly in the range of C8 to C16 and boiling in the range of approximately 120°C to 283°C (284°F to 541°F).
285-507-7
85116-55-8
Asp. Tox. 1
Distillates (petroleum), hydrodesulfurized thermal cracked middle; Cracked gasoil [ complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized themal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of approximately 205 °C to 400o°C (401°F to 752°F).]
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of approximately 205° C to 400°C (401°F to 752°F).
285-505-6
85116-53-6
Carc. 1B
reaction mass of dodecyl 3-(2,2,4,4-tetramethyl-21-oxo-7-oxa-3,20-diazadispiro(5,1,11,2)henicosan-20-yl)propionate and tetradecyl 3-(2,2,4,4-tetramethyl-21-oxo-7-oxa-3,20-diazadispiro(5,1,11,2)henicosan-20-yl)propionate
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
Petrolatum (petroleum), alumina-treated; Petrolatum [A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.]
A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.
285-098-5
85029-74-9
Carc. 1B
Distillates (coal), coke-oven light oil, naphthalene cut; Naphthalene Oil [The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148 °C (298°F).]
The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148°C (298°F).
285-076-5
85029-51-2
Carc. 1B; Muta. 1B
BBP; benzyl butyl phthalate e
201-622-7
85-68-7
Repr. 1B
yes
phthalic anhydride
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydrophthalic anhydride
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
cyclohexane-1,2-dicarboxylic anhydride
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
chlorfenac(ISO); 2,3,6-trichlorophenylacetic acid
201-599-3
85-34-7
Acute Tox. 4
Phenanthrene
201-581-5
85-01-8
yes
diquat dibromide
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Extract oils (coal), acidic, tar-base free; Methylnaphthalene Oil Extract Residue [The extract oil boiling in the range of approximately 220 °C to 265 °C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.]
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 1B
Distillates (coal tar), upper, fluorene-rich; Wash Oil Redistillate [A complex combination of hydrocarbons obtained by the crystallization of tar oil. It consists af aromatic and polycyclic hydrocarbons primarily fluorene and some acenaphthene.]
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from coal tar. It consists of aromatic and polycyclic hydrocarbons, primarily fluorene and acenaphthene.
284-900-0
84989-11-7
Carc. 1B
Distillates (coal tar), upper, fluorene-free; Wash Oil Redistillate [A complex combination of hydrocarbons obtained by the crystallization of tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.]
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.
284-899-7
84989-10-6
Carc. 1B
Distillates (coal tar), naph thalene oils, naphthalene-low; Naphthalene Oil Redistillate [ complex combination of hydrocarbons obtained by crys tallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.]
A complex combination of hydrocarbons obtained by crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
Carc. 1B; Muta. 1B
Tar acids, 3,5-xylenol fraction; Distillate Phenols [he fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.]
The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.
284-896-0
84989-07-1
Carc. 1B; Muta. 1B
Tar acids, xylenol fraction; Distillate Phenols [he fraction of tar acids, rich in 2,4-and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.]
The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-895-5
84989-06-0
Carc. 1B; Muta. 1B
Tar acids, polyalkylphenol fraction; Distillate Phenols [he fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225 °C to 320 °C (437°F to 608°F). Composed primarily of polyalkylphenols.]
The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225°C to 320°C (437°F to 608°F). Composed primarily of polyalkylphenols.
284-893-4
84989-05-9
Carc. 1B; Muta. 1B
Tar acids, methylphenol fraction; Distillate Phenols [he fraction of tar acid rich in 3-and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.]
The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-892-9
84989-04-8
Carc. 1B; Muta. 1B
Tar acids, ethylphenol fraction; Distillate Phenols [he fraction of tar acids, rich in 3-and 4-ethylphenol, recovered by distillation of low-temperature coal tar rude tar acids.]
The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-891-3
84989-03-7
Carc. 1B; Muta. 1B
Phenols, ammonia liquor ext.; Alkaline Extract [he combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700 °C (1292°F)) destructive distillation of coal. It consists predominantly of a reaction mass of monohydric and dihydric phenols.]
The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C (1292°F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.
284-881-9
84988-93-2
Carc. 1B; Muta. 1B
(2-ethylhexanoato-O)(isodecanoato-O)nickel
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel bis(isononanoate)
284-349-6
84852-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isodecanoato-O)(isononanoato-O)nickel
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isooctanoato-O)(neodecanoato-O)nickel
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
4-nonylphenol, branched
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
N-[1-(S)-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-N-carboxyanhydride
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
reaction mass of: succinic acid; monopersuccinic acid; dipersuccinic acid monomethyl ester of succinic acid monomethyl ester of persuccinic acid dimethyl succinate glutaric acid monoperglutaric acid diperglutaric acid monomethyl ester of glutaric acid monomethyl ester of perglutaric acid dimethyl glutarate adipic acid monoperadipic acid diperadipic acid monomethyl ester of adipic acid monomethyl ester of peradipic aciddimethyl adipate hydrogen peroxide methanolwater
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
1,2-benzenedicarboxylic acid, dipentylester, branched and linear
284-032-2
84777-06-0
Repr. 1B
yes
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
Distillates (coal tar), naphthalene oils; Naphthalene Oil [ complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compound and aromatic nitrogen compounds and distills in the approximate range of 200 °C to 250 °C (392°F to 482°F).]-
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200°C to 250°C (392°F to 482°F).
283-484-8
84650-04-4
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils; Carbolic Oil [A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150 o C to 210 o C (302 °F to 410 °F).]
A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C (302°F to 410°F).
283-483-2
84650-03-3
Carc. 1B; Muta. 1B
Distillates (coal tar), benzole fraction; Light Oil [A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160 °C (175°F to 320°F).]
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
tetrapotassium 4-[5-[3-carboxylato-4,5-dihydro-5-oxo1-(4-sulfonatophenyl)pyrazol-4-ylidene]-3-(piperidinocarbonyl)penta-1,3-dienylidene]-5-hydroxy-1-(4-sulfonatophenyl)pyrazole-3-carboxylate
430-390-1
845730-14-5
Acute Tox. 4
trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate
430-280-3
844491-96-9
Skin Sens. 1
chlozolinate (ISO); ethyl (RS)-3-(3,5-dichlorophenyl)-5-methyl-2,4-dioxo-oxazolidine-5-carboxylate
282-714-4
84332-86-5
Carc. 2
N-[6,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6-oxo-1H-purin-2-yl]acetamide
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
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