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 svibnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C2 through C4 and boiling in the range of approximately -51°C to -34°C (-60°F to -30°F).
272-205-5
68783-65-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C3 through C5.
272-203-4
68783-64-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
272-187-9
68783-13-1
Carc. 1B
Details
A complex combination of hydrocarbons produced from the distillation of naphtha streams from various refinery processes. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 0°C to 230°C (25°F to 446°F).
272-186-3
68783-12-0
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 by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C35 and boiling in the range of approximately 121°C to 510°C (250°F to 950°F).
272-184-2
68783-08-4
Carc. 1B
Details
A complex combination obtained from various refinery processes. It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-183-7
68783-07-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination obtained by the liquid-vapor separation of the hydrocracking process reactor effluent. It consists predominantly of hydrogen and saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
272-182-1
68783-06-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
272-180-0
68783-04-0
Carc. 1B
Details
An aromatic concentrate produced by adding water to heavy naphthenic distillate solvent extract and extraction solvent.
272-175-3
68783-00-6
Carc. 1B
Details
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
Details
211-694-1
687-47-8
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
Details
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
272-013-1
68648-93-1
R Toxic for reproduction (article 57c)
Details
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
Details
FAT 92'364/A
411-990-2
68612-94-2
Skin Sens. 1
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77900.
271-853-6
68610-24-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
271-846-8
68609-97-2
Skin Irrit. 2; Skin Sens. 1
Details
A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.
271-763-7
68607-30-7
Carc. 1B
Details
A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.
271-750-6
68607-11-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists predominantly of butane, isobutane and butadiene.
271-742-2
68606-34-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C4.
271-737-5
68606-27-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
271-735-4
68606-26-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
271-734-9
68606-25-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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 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
271-635-0
68603-08-7
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 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 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 produced by the fractionation of the overhead products from the catalytic cracking process in the fluidized catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
271-625-6
68602-84-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by the distillation of crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
271-624-0
68602-83-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanizing. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene.
271-623-5
68602-82-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
-
68583-35-7
B Bacteria and similar species
Details
-
68583-29-9
B Bacteria and similar species
Details
-
68583-16-4
B Bacteria and similar species
Details
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
Details
A distillate oil having a minimum viscosity of 900 SUS at 37.7°C (100°F) to a maximum of 9000 SUS at 37.7°C (100°F).
271-384-7
68553-00-4
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 with some butanes and boiling in the range of approximately 35°C to 200°C (95°F to 428°F).
271-267-0
68527-27-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80°C to 218°C (176°F to 424°F).
271-266-5
68527-26-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9 and boiling in the range of approximately 110°C to 165°C (230°F to 329°F).
271-264-4
68527-23-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 93°C to 180°C (200°F to 356°F).
271-263-9
68527-22-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons resulting from treatment of full-range straight-run naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. 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 220°C (-4°F to 429°F).
271-262-3
68527-21-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
271-261-8
68527-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by distillation of the products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C9 and boiling in the range of from approximately 205°C to 400°C (400°F to 752°F)
271-260-2
68527-18-4
Carc. 1B
Details
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approximately minus 164°C to minus 42°C (-263°F to -44°F).
271-259-7
68527-16-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination separated by distillation of a gas stream containing hydrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers in the range of C1 through C6 or obtained by cracking ethane and propane. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C2, hydrogen, nitrogen, and carbon monoxide.
271-258-1
68527-15-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by the distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 130°C to 220°C(266°F to 428°F).
271-138-9
68516-20-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
An inorganic pigment that is the reaction product of high temperature calcination in which nickel (II) oxide and silicon oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of olivine. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
271-112-7
68515-84-4
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
271-094-0
68515-51-5
R Toxic for reproduction (article 57c)
Details

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