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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
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
Tar acids, cresylic, sodium salts, caustic solns.; Alkaline Extract
272-361-4
68815-21-4
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 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
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, 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, residues, distillates, first-cut; Distillate Phenols [he residue from the distillation in the range of 235 °C to 355 °C (481°F to 697°F) of light carbolic oil.]
The residue from the distillation in the range of 235°C to 355°C (481°F to 697°F) of light carbolic oil.
270-713-1
68477-23-6
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 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, crude; Crude Tar Bases [he reaction product obtained by neutralizing coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.]
The reaction product obtained by neutralizing coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.
266-018-8
65996-84-1
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, quinoline derivs. fraction; Distillate Bases
274-560-1
70321-67-4
Carc. 1B; Muta. 1B
Tar bases, coal, toluidine fraction; Distillate Bases
293-767-8
91082-53-0
Carc. 1B; Muta. 1B
Tar bases, quinoline derivs.; Distillate Bases
271-020-7
68513-87-1
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 oils, coal, low-temp.; Tar Oil, high boiling [ distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160 °C to 340 °C (320°F to 644°F).]
A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C (320°F to 644°F).
309-889-2
101316-87-4
Carc. 1B; Muta. 1B
Tar oils, coal; Carbolic Oil [The distillate from high temperature coal tar having an approximate distillation range of 130 o C to 250 o C (266 oF to 410 oF). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.]
The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
266-016-7
65996-82-9
Carc. 1B; Muta. 1B
2,2'-bioxirane; 1,2:3,4-diepoxybutane
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
methyl acrylamidomethoxyacetate (containing ≥ 0,1 % acrylamid)
MAGME 100 MONOMEER
401-890-7
77402-03-0
Carc. 1B; Muta. 1B; Acute Tox. 4; Eye Irrit. 2
cadmium carbonate
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium hydroxide; cadmium dihydroxide
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium nitrate; cadmium dinitrate
233-710-6
10325-94-7
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
O-hexyl-N-ethoxycarbonylthiocarbamate
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
diethyl sulphate
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
Aromatic hydrocarbons, C6-10, acid-treated, neutralized; Low boiling point naphtha — unspecified
268-618-5
68131-49-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816 o C (1 500 °F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.]
A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.
270-658-3
68475-70-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Aromatic hydrocarbons, C7-12, C8-rich; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130 °C to 200 °C (266°F to 392°F).]
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C (266°F to 392°F).
297-401-8
93571-75-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Aromatic hydrocarbons, C7-8, dealkylation products, distn. residues; Low boiling point naphtha — unspecified
292-698-0
90989-42-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Aromatic hydrocarbons, C8, catalytic reforming-derived; Low boiling point cat-reformed naphtha
295-279-0
91995-18-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Aromatic hydrocarbons, C8-10; Low boiling point naphtha -unspecified
292-695-4
90989-39-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), C3-5, 2-methyl-2-butene-rich; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons from the distil lation of hydrocarbons usually ranging in carbon numbers from C3 through C5, predominantly isopentane and 3-methyl-1-butene. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C5, predominantly 2-methyl-2-butene.]
A complex combination of hydrocarbons from the distillation of hydrocarbons usually ranging in carbon numbers from C3 through C5, predominantly isopentane and 3-methyl-1-butene. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C5, predominantly 2-methyl-2-butene.
270-725-7
68477-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), C6-rich; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C5 through C7, rich in C6, and boiling in the range of approximately 60o C to70o C (140 °F to 158 °F).]
A complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C5 through C7, rich in C6, and boiling in the range of approximately 60°C to 70°C (140°F to 158°F).
296-903-4
93165-19-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), C7-9, C8-rich, hydrodesulfurized dearomatized; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120 o C to 130 o C (248 °F to 266 °F).]
A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120°C to 130°C (248°F to 266°F).
309-862-5
101316-56-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), catalytic reformed depentanizer; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons from the distillation of products from a catalytic reforming process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately - 49 °C to 63 °C (-57°F to 145°F).]
A complex combination of hydrocarbons from the distillation of products from a catalytic reforming process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -49°C to 63°C (-57°F to 145°F).
270-660-4
68475-79-6
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
Distillates (petroleum), catalytic reformed straight-run naphtha overheads; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha followed by the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.]
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha followed by the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
271-008-1
68513-63-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), depentanizer overheads; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained from a catalytic cracked gas stream. It consists of aliphatic hydro carbons having carbon numbers predominantly in the range of C4 through C6.]
A complex combination of hydrocarbons obtained from a catalytic cracked gas stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
270-771-8
68477-89-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), heat-soaked steam-cracked naphtha, C5-rich; Low boiling point naphtha — unspecified [ complex combination of hydrocarbons obtained by distillation of heat-soaked steam- cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.]
A complex combination of hydrocarbons obtained by distillation of heat-soaked steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.
295-302-4
91995-41-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), heavy arom.; Low boiling point thermally cracked naphtha [he complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This higher boiling fraction consists predominantly of C5-7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having carbon number predominantly of C5. This stream may contain benzene.]
The complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This higher boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having carbon number predominantly of C5. This stream may contain benzene.
267-563-4
67891-79-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer overheads; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained by distillation of the products from a heavy naphtha hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately - 49 °C to 68 °C (- 57°F to 155°F).]
A complex combination of hydrocarbons obtained by distillation of the products from a heavy naphtha hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -49°C to 68°C (-57°F to 155°F).
270-094-8
68410-98-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), hydrotreated middle, intermediate boiling; Low boiling point hydrogen treated naphtha [A complex combination of hydrocarbons obtained by the distillation of products from a middle distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 127o C to 188o C (262°F to 370°F).]
A complex combination of hydrocarbons obtained by the distillation of products from a middle distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 127°C to 188°C (262°F to 370°F).
270-092-7
68410-96-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), light arom.; Low boiling point thermally cracked naphtha [he complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This lower boiling fraction consists predominantly of C5-7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C5. This stream may contain benzene.]
The complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This lower boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C5. This stream may contain benzene.
267-565-5
67891-80-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), light distillate hydrotreating process, low-boiling; Low boiling point hydrogen treated naphtha [A complex combination of hydrocarbons obtained by the distillation of products from the light distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C9 and boiling in the range of approximately 3 o C to 194 o C (37 °F to 382 °F).]
A complex combination of hydrocarbons obtained by the distillation of products from the light distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C9 and boiling in the range of approximately 3°C to 194°C (37°F to 382°F).
270-093-2
68410-97-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), light straight-run gasoline frac tionation stabilizer overheads; Low boiling point naphtha [ complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in he range of C3 through C6.]
A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6.
272-931-2
68921-08-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), light thermal cracked, debutanized arom.; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.]
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.
273-266-0
68955-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), naphtha steam cracking-derived, hydro-treated light arom.; Low boiling point cat-cracked naphtha. [ complex combination of hydrocarbons obtained by treating a light distillate from steam-cracked naphtha. It consists predominantly of aromatic hydrocarbons.]
A complex combination of hydrocarbons obtained by treating a light distillate from steam-cracked naphtha. It consists predominantly of aromatic hydrocarbons.
295-311-3
91995-50-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
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