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 (petroleum), solvent-refined heavy naphthenic; Baseoil — unspecified [A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. 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 a 40 °C). It contains relatively few normal paraffins.]

A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. 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. EC / List no: 265-097-6 CAS no: 64741-96-4
EU CLP (1272/2008)
Carc. 1B