EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 15 srpnja 2024. Database contains 4821 unique substances/entries.
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A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-095-5
64741-92-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic 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).
265-093-4
64741-91-9
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205°C to 400°C (401°F to 752°F).
265-092-9
64741-90-8
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-091-3
64741-89-5
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated 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).
265-090-8
64741-88-4
Carc. 1B
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
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
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 190°C (95°F to 374°F).
265-086-6
64741-84-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 220°C (148°F to 428°F).
265-085-0
64741-83-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from the distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C10 through C22 and boiling in the range of approximately 160°C to 370°C (320°F to 698°F).
265-084-5
64741-82-8
Carc. 1B
A complex combination of hydrocarbons from the distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C15 through C36 and boiling in the range of approximately 260°C to 480°C (500°F to 896°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-082-4
64741-81-7
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a thermal cracking process. It consists predominantly of unsaturated 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.
265-081-9
64741-80-6
Carc. 1B
A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12, and boiling in the range of approximately 65°C to 230°C (148°F to 446°F).
265-079-8
64741-78-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C10 through C18, and boiling in the range of approximately 160°C to 320°C (320°F to 608°F).
265-078-2
64741-77-1
Carc. 2
A complex combination of hydrocarbons from the distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers in the range of C15-C39 and boiling in the range of approximately 260°C to 600°C (500°F to 1112°F).
265-077-7
64741-76-0
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F).
265-076-1
64741-75-9
Carc. 1B
A complex combination of hydrocarbons from distillation of products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 10°C to 130°C (14°F to 266°F).
265-075-6
64741-74-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by 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 C11 through C17 and boiling in the range of approximately 205°C to 320°C (401°F to 608°F).
265-074-0
64741-73-7
Asp. Tox. 1
A complex combination of hydrocarbons obtained from catalytic isomerization of straight chain paraffinic C4 through C6 hydrocarbons. It consists predominantly of saturated hydrocarbons such as isobutane, isopentane, 2,2-dimethylbutane, 2-methylpentane, and 3-methylpentane.
265-073-5
64741-70-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C4 through C10, and boiling in the range of approximately minus 20°C to 180°C (-4°F to 356°F).
265-071-4
64741-69-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-070-9
64741-68-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C25 and boiling in the range of approximately 160°C to 400°C (320°F to 725°F). This stream is likely to contain 5 wt. % or more of 4- or 6-membered condensed ring aromatic hydrocarbons.
265-069-3
64741-67-9
Carc. 1B
A complex combination of hydrocarbons produced by 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 C10 and boiling in the range of approximately 90°C to 160°C (194°F to 320°F).
265-068-8
64741-66-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 to C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 150°C to 220°C (302°F to 428°F).
265-067-2
64741-65-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by 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 and boiling in the range of approximately 90°C to 220°C (194°F to 428°F).
265-066-7
64741-64-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 190°C (95°F to 374°F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.
265-065-1
64741-63-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists 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.
265-064-6
64741-62-4
Carc. 1B
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 C15 through C35 and boiling in the range of approximately 260°C to 500°C (500°F to 932°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-063-0
64741-61-3
Carc. 1B
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 C11 through C30 and boiling in the range of approximately 205°C to 450°C (401°F to 842°F). It contains a relatively large proportion of tricyclic aromatic hydrocarbons.
265-062-5
64741-60-2
Carc. 1B
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 C9 through C25 and boiling in the range of approximately 150°C to 400°C (302°F to 752°F). It contains a relatively large proportion of bicyclic aromatic hydrocarbons.
265-060-4
64741-59-9
Carc. 1B
A complex combination of hydrocarbons produced by the 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 boiling in the range of approximately 350°C to 600°C (662°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-058-3
64741-57-7
Carc. 1B
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 C4 through C11 and boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F). It contains a relatively large proportion of unsaturated hydrocarbons.
265-056-2
64741-55-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by a distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 230°C (148°F to 446°F). It contains a relatively large proportion of unsaturated hydrocarbons.
265-055-7
64741-54-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 relatively few normal paraffins.
265-054-1
64741-53-3
Carc. 1A
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 C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-053-6
64741-52-2
Carc. 1A
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
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 C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons normally present in this distillation range of crude oil.
265-051-5
64741-50-0
Carc. 1A
A complex combination of hydrocarbons separated as a liquid from natural gas in a gas recycling plant by processes such as refrigeration or absorption. It consists mainly of saturated aliphatic hydrocarbons having carbon numbers in the range of C2 through C8.
265-048-9
64741-48-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated as a liquid from natural gas in a surface separator by retrograde condensation. It consists mainly of hydrocarbons having carbon numbers predominantly in the range of C2 to C20. It is a liquid at atmospheric temperature and pressure.
265-047-3
64741-47-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of crude oil. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately minus 20°C to 180°C (-4°F to 356°F).
265-046-8
64741-46-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex residuum from the atmospheric distillation of crude oil. It consists 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.
265-045-2
64741-45-3
Carc. 1B
A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20°C to 220°C (-4°F to 428°F).
265-042-6
64741-42-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 230°C (149°F to 446°F).
265-041-0
64741-41-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
211-463-5
646-06-0
Flam. Liq. 2
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
211-420-0
644-64-4
Acute Tox. 3; Acute Tox. 4
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
425-760-4
64137-52-6
Eye Dam. 1
211-363-1
640-19-7
Acute Tox. 2; Acute Tox. 3
211-362-6
640-15-3
Acute Tox. 3; Acute Tox. 4

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