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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 listopada 2024. Database contains 4821 unique substances/entries.
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Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73°C to 85°C (163°F to 185°F).
295-529-9
92062-15-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
295-523-6
92062-09-4
Carc. 1B
A complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temperature. It boils in the range of approximately 147°C to 300°C (297°F to 572°F) and produces a finished oil having a viscosity of 18cSt at 50°C.
295-517-3
92062-04-9
Carc. 1B
A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C (32°F to 662°F).
295-514-7
92062-00-5
Carc. 1B
A complex combination of hydrocarbons produced as the residual fraction from the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F).
295-511-0
92061-97-7
Carc. 1B
Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752°F to 846°F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.
295-507-9
92061-94-4
Carc. 1B
The residue from the fractional distillation of wash oil boiling in the approximate range of 270°C to 330°C (518°F to 626°F). It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.
295-506-3
92061-93-3
Carc. 1B

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