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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Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated; Distillate aromatic extract (treated) [A complex combination of hydrocarbons obtained by treating a heavy naphthenic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predomi nantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 19cSt at 40 °C (100 SUS at 100 °F).]

A complex combination of hydrocarbons obtained by treating a heavy naphthenic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 19cSt at 40°C (100 SUS at 100°F). EC / List no: 292-631-5 CAS no: 90641-07-9
EU CLP (1272/2008)
Carc. 1B