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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Hydrocarbons, C12-20, hydrotreated paraffinic, distn. lights; Gasoil — unspecified [A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluent from the treatment of heavy paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C20 and boiling in the range of approximately 230 °C to 350 °C (446 °F to 662 °F). It produces a finished oil having viscosity of 2cSt at 100°C (212°F).]

A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of heavy paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C20 and boiling in the range of approximately 230°C to 350°C (446°F to 662°F). It produces a finished oil having a viscosity of 2cSt at 100°C (212°F). EC / List no: 307-660-1 CAS no: 97675-86-0
EU CLP (1272/2008)
Carc. 1B