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 rujna 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by subjecting a catalytic cracked petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 60°C to 200°C (140°F to 392°F).
295-431-6
92045-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by alkylation of butanes. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12, rich in isooctane, and boiling in the range of approximately 35°C to 210°C (95°F to 410°F).
295-430-0
92045-49-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
295-424-8
92045-43-7
Carc. 1B
Details
295-423-2
92045-42-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a wide cut hydrocarbon fuel cut from atmospheric distillation and boiling in the range of approximately 70°C to 220°C (158°F to 428°F).
295-418-5
92045-37-9
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from a petroleum stock by solvent refining and sweetening and boiling in the range of approximately 150°C to 260°C (302°F to 500°F).
295-416-4
92045-36-8
Asp. Tox. 1
Details
295-411-7
92045-29-9
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately minus 12°C to 5°C (10.4°F to 41°F).
295-405-4
92045-23-3
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 propylene with some propane and boils in the range of approximately minus 70°C to 0°C (minus 94°F to 32°F).
295-404-9
92045-22-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination obtained from viscosity reduction of residues in a furnace. It consists predominantly of hydrogen sulfide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
295-402-8
92045-20-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination obtained as a mixture of the non-condensable portions from the product of a naphtha steam cracking process as well as residual gases obtained during the preparation of subsequent products. It consists predominantly of hydrogen and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5 with which natural gas may also be mixed.
295-401-2
92045-19-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of gases obtained from flash of the effluents after the hydrogenation reaction. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
295-400-7
92045-18-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of gases obtained from the reformer and from the purges from the hydrogenation reactor. It consists predominantly of hydrogen and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
295-399-3
92045-17-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination obtained by separation of the liquid phase from the effluent from the hydrogenation reaction. It consists predominantly of hydrogen, hydrogen sulfide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
295-398-8
92045-16-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination produced by desulfurization of gas oils with diethanolamine. It consists predominantly of hydrogen sulfide, hydrogen and aliphatic hydrocarbons having carbon numbers in the range of C1 through C5.
295-397-2
92045-15-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of crude petroleum. It consists predominantly of aliphatic, aromatic and cycloaliphatic hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
295-396-7
92045-14-2
Carc. 1B
Details
295-394-6
92045-12-0
Carc. 1B
Details
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
Details
202-204-7
92-93-3
Carc. 1B
Details
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
Details
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
C Carcinogenic (article 57a)
Details
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
202-155-1
92-43-3
Acute Tox. 4
Details
202-128-4
92-13-7
Acute Tox. 2
Details
A complex combination of hydrocarbons, obtained by solvent extraction from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-342-2
91995-79-8
Carc. 1B
Details

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