EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). 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).

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Distillates (coal), solvent extn., hydrocracked middle [Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 °C to 300 °C (356°F to 572°F. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.]

Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 300°C (356°F to 572°F. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present. EC / List no: 302-692-2 CAS no: 94114-56-4
EU CLP (1272/2008)
Carc. 1B; Muta. 1B