EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the 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).

Last updated 21 lipnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained as a redistillate from the fractional distillation of bituminous coal high temperature tar and residual oils that are obtained by the pyrolytic production of alkenes and alkynes from petroleum products or natural gas. It consists predominantly of indene and boils in a range of approximately 160°C to 190°C (320°F to 374°F).
295-292-1
91995-31-2
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C20 and boiling in the range of approximately 205°C to 345°C (401°F to 653°F).
265-113-1
64742-13-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150°C to 290°C (302°F to 554°F).
265-114-7
64742-14-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-121-5
64742-21-8
Carc. 1A
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-118-9
64742-19-4
Carc. 1A
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-119-4
64742-20-7
Carc. 1A
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-117-3
64742-18-3
Carc. 1A
Details
A complex combination of hydrocarbons obtained from the distillation of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C16 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F).
295-294-2
91995-34-5
Carc. 1B
Details
The distillate from a mixture of coal tar and aromatic petroleum streams having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of 3- to 4-membered condensed ring aromatic hydrocarbons.
269-159-3
68188-48-7
Carc. 1B
Details
Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 300°C (356°F to 572°F. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.
302-692-2
94114-56-4
Carc. 1B; Muta. 1B
Details
Distillate from the hydrogenation of hydrocracked middle distillate from coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 280°C (356°F to 536°F). Composed primarily of hydrogenated two- ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C9 through C14.
302-693-8
94114-57-5
Carc. 1B; Muta. 1B
Details
Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 through C14. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-689-6
94114-53-1
Carc. 1B; Muta. 1B
Details
The liquid product of condensation of vapors emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C4 through C14.
302-688-0
94114-52-0
Carc. 1B; Muta. 1B
Details
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
Details
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
Details
The distillate from coal tar having an approximate distillation range of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.
266-027-7
65996-92-1
Carc. 1B
Details
The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
266-026-1
65996-91-0
Carc. 1B
Details
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
Details
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
Details
The oil obtained from condensation of the vapors from the heat treatment of pitch. Composed primarily of two- to four-ring aromatic compounds boiling in the range of 200°C to greater than 400°C (392°F to greater than 752°F).
309-855-7
101316-49-8
Carc. 1B
Details
The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380°C to 410°C (716°F to 770°F). Composed primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic compounds.
295-313-4
91995-52-7
Carc. 1B
Details
The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri- and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300°C to 470°C (572°F to 878°F). The product may also contain heteroatoms.
295-312-9
91995-51-6
Carc. 1B
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
292-607-4
90640-86-1
Carc. 1B
Details
The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons.
295-304-5
91995-42-5
Carc. 1B
Details
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
Details
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
Details
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
Details
240-221-1
16071-86-6
Carc. 1B
Details
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
215-540-4
1330-43-4
Repr. 1B
R Toxic for reproduction (article 57c)
Details
601-808-1
12179-04-3
Repr. 1B
R Toxic for reproduction (article 57c)
Details
603-411-9
1303-96-4
Repr. 1B
R Toxic for reproduction (article 57c)
Details
215-211-5
1313-82-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
Details
DURALINK (R) HTS; ERP-390
401-320-7
5719-73-3
Skin Sens. 1
Details
602-894-3
12280-03-4
Repr. 1B
Details
234-541-0
12008-41-2
Repr. 1B
R Toxic for reproduction (article 57c)
Details
DIDA
402-360-8
92511-22-3
Eye Dam. 1
Details
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
Details

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