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 15 srpnja 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 of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653°F).
265-088-7
64741-86-2
Carc. 1B
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 from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 through C18.
270-662-5
68475-80-9
Carc. 1B
Details
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. 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 a relatively large proportion of saturated aliphatic hydrocarbons.
265-052-0
64741-51-1
Carc. 1A
Details
BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
407-130-0
65232-89-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
428-020-9
6195-20-6
Skin Sens. 1
Details
200-449-4
60-00-4
Eye Irrit. 2
Details
613-911-9
66230-04-4
Acute Tox. 3; STOT SE 1; STOT RE 2; Skin Sens. 1
Details
200-578-6
64-17-5
Flam. Liq. 2
Details
211-694-1
687-47-8
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
Details
414-920-9
60658-04-0
Acute Tox. 3; STOT RE 1; Skin Sens. 1
Details
266-362-9
66441-23-4
Skin Sens. 1
Details
LUPEROX 533
403-320-2
67567-23-1
Org. Perox. D; Flam. Liq. 3
Details
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
Details
434-630-6
60372-77-2
Eye Dam. 1
Details
210-903-3
625-58-1
Unst. Expl.
Details
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
Details
425-430-1
6746-94-7
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
Details
The extract produced by the acidic extraction of bases from crude coal tar aromatic oils, neutralization, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.
273-077-3
68937-63-3
Carc. 1B; Muta. 1B
Details
The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.
266-020-9
65996-86-3
Carc. 1B; Muta. 1B
Details
The residue obtained from coal tar oil by an alkaline wash such as aqueous sodium hydroxide after the removal of crude coal tar acids. Composed primarily of naphthalenes and aromatic nitrogen bases.
266-021-4
65996-87-4
Carc. 1B; Muta. 1B
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 combination of hydrocarbons obtained as the extract from a solvent extraction 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 90°C to 220°C (194°F to 428°F).
265-099-7
64741-98-6
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-111-0
64742-11-6
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
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-103-7
64742-04-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the extract from a solvent extraction of heavy paraffinic distillate.
272-342-0
68814-89-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-102-1
64742-03-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-104-2
64742-05-8
Carc. 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
The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
266-017-2
65996-83-0
Carc. 1B; Muta. 1B
Details
262-095-7
60168-88-9
Repr. 2; Lact.
Details
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
Details
274-125-6
69806-50-4
Repr. 1B
Details
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
262-661-3
61213-25-0
Repr. 1B; Acute Tox. 4; Skin Sens. 1
Details
A complex combination of hydrocarbons obtained as the oil fraction from a solvent deoiling or a wax sweating process. It consists predominantly of branched chain hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
265-171-8
64742-67-2
Carc. 1B
Details
614-346-0
68157-60-8
Carc. 2
Details
200-579-1
64-18-6
Skin Corr. 1A
Details
268-755-0
68134-59-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
A complex combination of light gases produced by distillation of crude oil and by catalytic reforming of naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately -217°C to -12°C (-423°F to 10°F).
270-670-9
68476-29-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A combination of light gases. It consists predominantly of hydrogen and/or low molecular weight hydrocarbons.
270-667-2
68476-26-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C (100°F) to a maximum of 37.9 SUS at 37.7°C (100°F).
270-671-4
68476-30-2
Carc. 2
Details
A distillate oil having a minimum viscosity of 45 SUS at 37.7°C (100°F) to a maximum of 125 SUS at 37.7°C (100°F).
270-673-5
68476-31-3
Carc. 2
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
The liquid product from various refinery streams, usually residues. The composition is complex and varies with the source of the crude oil.
270-675-6
68476-33-5
Carc. 1B
Details
270-674-0
68476-32-4
Carc. 1B
Details
A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C (100°F) to a maximum of 40.1 SUS at 37.7°C (100°F).
270-676-1
68476-34-6
Carc. 2
Details

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