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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Tar bases, coal, aniline fraction; Distillate Bases [The distillation fraction boiling in the range of approximately 180o C to 200o C (356 oF to 392 oF) from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar.; It contains chiefly aniline, collidines, lutidines and toluidines.]

The distillation fraction boiling in the range of approximately 180°C to 200°C (356°F to 392°F) from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar. It contains chiefly aniline, collidines, lutidines and toluidines. EC / List no: 295-541-4 CAS no: 92062-27-6
EU CLP (1272/2008)
Carc. 1B; Muta. 1B