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 17 srpnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by catalytic dehydrosulfurization of thermal-cracked light vacuum petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C20 and boiling in the range of approximately 270°C to 370°C (518°F to 698°F).
308-278-8
97926-59-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of heavy naphthic solvent petroleum extract with bleaching earth. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C10 and boiling in the range of approximately 80°C to 180°C (175°F to 356°F).
308-261-5
97926-43-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
308-208-6
97925-95-6
Repr. 1B
Details
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
Details
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
Details
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
Details
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-150-1
97862-98-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-149-6
97862-97-0
Carc. 1B
Details
308-133-9
97862-83-4
Carc. 1B
Details
308-132-3
97862-82-3
Carc. 1B
Details
308-131-8
97862-81-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained from the redistillation of the effluents from the treatment of paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C27 and boiling in the range of approximately 330°C to 340°C (626°F to 644°F).
308-128-1
97862-78-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-127-6
97862-77-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of Foots oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-126-0
97862-76-5
Carc. 1B
Details
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 16cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C29 and boiling in the range of approximately 250°C to 425°C (482°F to 797°F).
307-760-5
97722-10-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 9.5cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C27 and boiling in the range of approximately 240°C to 400°C (464°F to 752°F).
307-758-4
97722-09-3
Carc. 1B
Details
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 2.2cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 through C17 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F).
307-757-9
97722-08-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the catalytic hydrotreatment of a solvent deasphalted short residue having a viscosity of 8cSt at approximately 100°C (212°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C40 and boiling in the range of approximately 300°C to 500°C (592°F to 932°F).
307-755-8
97722-06-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction from a naphthenic distillate having a viscosity of 27cSt at 100°C (212°F). It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C26 through C55 and boiling in the range of approximately 395°C to 640°C (743°F to 1184°F).
307-753-7
97722-04-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent dewaxing of a distillation residue from a hydrocracked paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C20 and boiling in the range of approximately 360°C to 500°C (680°F to 932°F). It produces a finished oil having a viscosity of 4.5cSt at approximately 100°C (212°F).
307-662-2
97675-88-2
Carc. 2
Details
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a solvent-deasphalted short residue with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C30 and boiling in the range of approximately 300°C to 400°C (572°F to 752°F). It produces a finished oil having a viscosity of 4cSt at approximately 100°C (212°F).
307-661-7
97675-87-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of heavy paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C20 and boiling in the range of approximately 230°C to 350°C (446°F to 662°F). It produces a finished oil having a viscosity of 2cSt at 100°C (212°F).
307-660-1
97675-86-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a middle distillate with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C20 and boiling in the range of approximately 290°C to 350°C (554°F to 662°F). It produces a finished oil having a viscosity of 2cSt at 100°C (212°F).
307-659-6
97675-85-9
Carc. 1B
Details
307-451-5
97659-46-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-202-0
97553-43-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-035-3
97488-96-5
Carc. 1B
Details
307-034-8
97488-95-4
Carc. 1B
Details
307-033-2
97488-94-3
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the treatment of a hydrogenated petroleum distillate with a solvent. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C19 through C40 and boiling in the range of approximately 390°C to 550°C (734°F to 1022°F).
307-011-2
97488-74-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the solvent treatment of a distillate from hydrocracked petroleum distillates. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
307-010-7
97488-73-8
Carc. 1B
Details
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
Details
306-004-1
95465-89-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
305-975-9
95371-08-7
Carc. 1B
Details
305-974-3
95371-07-6
Carc. 1B
Details
305-972-2
95371-05-4
Carc. 1B
Details
305-971-7
95371-04-3
Carc. 1B
Details
A complex combination of hydrocarbons obtained by distillation of the polymerized C8 through C12 fraction from steam-cracked petroleum distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
305-750-5
95009-23-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-595-3
94733-16-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-594-8
94733-15-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent dearomatization of the residue of hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
305-589-0
94733-09-2
Carc. 1B
Details
305-588-5
94733-08-1
Carc. 1B
Details
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
Details
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
Diesel engine fuel produced by the hydrogenation of the middle distillate fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 200°C to 280°C (392°F to 536°F). Composed primarily of hydrogenated two-ring hydrocarbons and their alkyl derivatives having carbon numbers predominantly in the range of C11 through C14.
302-695-9
94114-59-7
Carc. 2
Details
Jet engine fuel produced by hydrogenation of the middle distillate fraction of the products of 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 225°C (356°F to 473°F). Composed primarily of hydrogenated two-ring hydrocarbons and their alkyl derivatives having carbon numbers predominantly in the range of C10 through C12.
302-694-3
94114-58-6
Carc. 2
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 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
Motor fuel produced by the reforming of the refined naphtha fraction of the products of 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 180°C (86°F to 356°F). Composed primarily of aromatic and naphthenic hydrocarbons, their alkyl derivatives and alkyl hydrocarbons having carbon numbers in the range of C4 through C9.
302-691-7
94114-55-3
Carc. 1B
Details
Fraction of the 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 180°C (86°F to 356°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 to C9. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-690-1
94114-54-2
Carc. 1B; Muta. 1B
Details

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