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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
6-methoxy-m-toluidine; p-cresidine
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
calcium chromate
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
hydrazobenzene; 1,2-diphenylhydrazine
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
nitrosodipropylamine
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
salts of 2,2'-dichloro-4,4'-methylenedianiline; salts of 4,4'-methylenebis(2-chloroaniline)
-
-
Carc. 1B; Acute Tox. 4
salts of 3,3'-dimethoxybenzidine; salts of o-dianisidine
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[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-49-1
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-48-0
(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, sulfate EC / List no: - | CAS no: 56436-30-7
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-38-8
3,3'-dimethoxybiphenyl-4,4'-ylenediammonium dichloride EC / List no: 243-737-5 | CAS no: 20325-40-0
(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, monohydrochloride EC / List no: - | CAS no: 111984-09-9
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-53-7
-
-
Carc. 1B; Acute Tox. 4
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine
277-985-0
74753-18-7
Carc. 1B; Acute Tox. 4
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine
265-294-7
64969-36-4
Carc. 1B; Acute Tox. 4
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine
210-322-5
612-82-8
Carc. 1B; Acute Tox. 4
strontium chromate
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
sulfallate (ISO); 2-chloroallyl N, N-dimethyldithiocarbamate
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
styrene oxide;(epoxyethyl)benzene; phenyloxirane
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
1-methyl-3-nitro-1-nitrosoguanidine
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
thioacetamide
200-541-4
62-55-5
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing < 0,1 % 4-chloroaniline (EC No 203-401-0)];1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing ≥ 0,1 % 4-chloroaniline (EC No 203-401-0)]
433-580-2
214353-17-0
Carc. 1B; Acute Tox. 4; Skin Corr. 1B
hydrazine bis(3-carboxy-4-hydroxybenzensulfonate)
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,3'-dichlorobenzidine; 3,3'-dichlorobiphenyl-4,4'-ylenediamine
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
4,4'-methylenedi-o-toluidine
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
4-amino-3-fluorophenol
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
salts of 3,3'-dichlorobenzidine; salts of 3,3'-dichlorobiphenyl-4,4'-ylenediamine
-
-
Carc. 1B; Acute Tox. 4; Skin Sens. 1
(6-(4-hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazin-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
2,2-bis(bromomethyl)propane-1,3-diol
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
Anthracene oil, anthracene paste, anthracene fraction; Anthracene Oil Fraction [ complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330 °C to 350 °C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.]
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
Carc. 1B; Muta. 1B
yes
Anthracene oil, anthracene paste, carbazole fraction; Anthracene Oil Fraction [ complex combination of hydrocarbons from the distil lation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350 °C to 360 °C (662°F to 680 °F). It contains chiefly anthracene, carbazole and phenanthrene.]
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
Anthracene oil, anthracene paste, distn. lights; Anthracene Oil Fraction [ complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290 °C to 340 °C (554°F to 644 °F). It contains chiefly trinuclear aromatics and their dihydro derivatives.]
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
Carc. 1B; Muta. 1B
yes
Anthracene oil, anthracene paste; Anthracene Oil Fraction [he anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.]
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
yes
Anthracene oil, anthracene-low; Anthracene Oil Fraction [he oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.]
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
yes
Aromatic hydrocarbons, C6-10, C8-rich; Light Oil Redistillate, low boiling
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
Aromatic hydrocarbons, C8-9, hydrocarbon resin polymn. by-product; Light Oil Redistillate, high boiling [ complex combination of hydrocarbons obtained from the evaporation of solven under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120 o C to 215 o C (248 °F to 419 °F).]
A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
295-281-1
91995-20-9
Carc. 1B; Muta. 1B
Aromatic hydrocarbons, C8; Light Oil Redistillate, high boiling
292-694-9
90989-38-1
Carc. 1B; Muta. 1B
Aromatic hydrocarbons, C9-12, benzene distn.; Light Oil Redistillate, high boiling
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
Benzol forerunnings (coal); Light Oil Redistillate, low boiling [The distillate from coke oven light oil having an approximate distillation range below 100 o C (212 °F). Composed primarily of C4 to C6 aliphatic hydrocarbons.]
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
Distillates (coal tar), benzole fraction, BTX-rich; Light Oil Redistillate, low boiling [ residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75 °C to 200 °C (167 °F to 392 °F).]
A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
309-984-9
101896-26-8
Carc. 1B; Muta. 1B
Distillates (coal tar), benzole fraction, distn. residues; Wash Oil [ complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300 °C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70 °C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.]
A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70°C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.
310-165-3
121620-46-0
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils, acid exts.; Light Oil Extract Residues, high boiling [This oil is a complex reaction mass of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m- and p-cresol and boiling in the range of 140o C to 215o C (284 °F to 419 °F).]
This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m-, and p-cresol and boiling in the range of 140°C to 215°C (284°F to 419°F).
292-609-5
90640-87-2
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils, alk. exts.; Alkaline Extract [he aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-610-0
90640-88-3
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils, neutral fraction; Light Oil Extract Residues, high boiling [A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135o C to 210o C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.
309-971-8
101794-90-5
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), 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
Distillates (coal tar), naphthalene oil crystn. mother liquor; Naphthalene Oil Redistillate [ complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200 °C to 230 °C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.]
A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.
295-310-8
91995-49-2
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, acid exts.; Methylnaphthalene Oil Extract Residue [ complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230 °C to 255 °C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.]
A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230°C to 255°C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.
295-309-2
91995-48-1
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, alk. exts.; Alkaline Extract [he aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-611-6
90640-89-4
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, indole-methylnaphthalene fraction; Methylnaphthalene Oil [ distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235 °C to 255 °C (455 °F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235°C to 255°C (455°F to 491°F).
309-972-3
101794-91-6
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, methylnaphthalene fraction; Methylnaphthalene Oil [ distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225 °C to 255 °C (437°F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225°C to 255°C (437°F to 491°F).
309-985-4
101896-27-9
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, naphthalene-free, alk. exts.; Naphthalene Oil Extract Residue [The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.]
The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.
292-612-1
90640-90-7
Carc. 1B; Muta. 1B
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), coal tar-residual pyrolysis oils, naphthalene oils; Redistillates [The redistillate obtained from the fractional distillation of bituminous coal high temperature tar and pyrolysis residual oils and boiling in the range of approximately 190o C to 270o C (374oF to 518oF). Composed primarily of substituted dinuclear aromatics.]
The redistillate obtained from the fractional distillation of bituminous coal high temperature tar and pyrolysis residual oils and boiling in the range of approximately 190°C to 270°C (374°F to 518°F). Composed primarily of substituted dinuclear aromatics.
295-295-8
91995-35-6
Carc. 1B; Muta. 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
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