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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 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

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