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, C11-17, solvent-extd. light naphthenic; Gasoil — unspecified [A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a visciosity of 2.2 cSt at 40 °C (104 °F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 through C17 and boiling in the range of approximately 200°C to 300°C (392°F to 572 °F).]

A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 2.2cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 through C17 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F). EC / List no: 307-757-9 CAS no: 97722-08-2
EU CLP (1272/2008)
Carc. 1B