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 20 lipnja 2024. Database contains 4917 unique substances/entries.
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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
Details
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
Details
A complex combination of hydrocarbons obtained as the raffinates from a solvent extraction process of hydrotreated light distillate from steam-cracked naphtha.
295-315-5
91995-53-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by stripping the products from the naphtha unifiner. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
272-932-8
68921-09-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
The complex combination of hydrocarbons obtained by the pyrolysis fractionation at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of hydrocarbons having a carbon number of C9 and boiling at approximately 204°C (400°F).
270-344-6
68425-29-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the distillation of polymerized steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-735-1
68477-50-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-738-8
68477-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-736-7
68477-53-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C7 and boiling in the range of approximately -88°C to 99°C (-127°F to 210°F).
270-077-5
68410-05-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33°C to 184°C (91°F to 363°F).
271-632-4
68603-01-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predominantly isoamylenes such as 2-methyl-1-butene and 2-methyl-2-butene and boiling in the range of approximately 31°C to 40°C (88°F to 104°F).
271-634-5
68603-03-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approximately 33°C to 60°C (91°F to 140°F).
271-631-9
68603-00-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
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
A complex combination of hydrocarbons obtained as the extract from the solvent extraction of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C8 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
295-331-2
91995-68-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.
270-741-4
68477-61-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 45°C to 185°C (113°F to 365°F).
297-458-9
93572-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 20°C to 120°C (-4°F to 248°F).
232-349-1
8006-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.
271-726-5
68606-10-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20°C to 200°C (68°F to 392°F).
302-639-3
94114-03-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36.1°C to 193.3°C (97°F to 380°F).
271-727-0
68606-11-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons separated from the gases from vapor recovery systems by cooling. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately -20°C to 196°C(-4°F to 384°F).
271-025-4
68514-15-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-687-1
68476-47-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillations of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C11 and boiling in a range approximately up to 204°C(400°F).
270-686-6
68476-46-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly C5.
310-012-0
102110-14-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from prehydrogenated cracked naphtha after distillative separation of benzene- and toluene-containing hydrocarbon cuts and a higher boiling fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30°C to 205°C (86°F to 401°F).
295-445-2
92045-63-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation from the product of a naphtha steam cracking process and subsequent catalytic selective hydrogenation of gum formers. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 230°C (86°F to 446°F).
295-443-1
92045-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as first runnings from the depentanizer column before hydrotreatment of the aromatic charges. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C6, predominantly pentanes and pentenes, and boiling in the range of approximately 25°C to 40°C (77°F to 104°F).
295-298-4
91995-38-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 125°C (94°F to 257°F), benzene and toluene.
297-466-2
93572-36-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C5 and dicyclopentadiene and boiling in the range of approximately 30°C to 170°C (86°F to 338°F).
310-013-6
102110-15-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-695-5
68476-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-852-0
93763-33-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the sorption of benzene from a catalytically fully hydrogenated benzene-rich hydrocarbon cut that was distillatively obtained from prehydrogenated cracked naphtha. It consists predominantly of paraffinic and naphthenic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 70°C to 100°C (158°F to 212°F).
295-446-8
92045-64-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained during the sorptions of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80°C to 135°C (176°F to 275°F).
309-870-9
101316-66-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65°C to 70°C (149°F to 158°F).
309-871-4
101316-67-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 120°C to 210°C (248°F to 380°F) and C9 and higher aromatic hydrocarbons.
297-465-7
93572-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C11 and boiling in the range of approximately 130°C to 205°C (266°F to 401°F).
295-444-7
92045-62-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140°C to 210°C (284°F to 410°F).
309-974-4
101794-97-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
309-987-5
101896-28-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
295-794-0
92128-94-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-853-6
93763-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-690-8
68476-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94°C to 99°C (201°F to 210°F).
295-436-3
92045-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20°C to 135°C (58°F to 275°F).
232-453-7
8032-32-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately minus 10°C to 230°C (14°F to 446°F).
265-089-2
64741-87-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
271-635-0
68603-08-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-185-8
68783-09-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the catalytic dewaxing of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35°C to 230°C (95°F to 446°F).
265-170-2
64742-66-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
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
Details

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