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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Naphtha (petroleum), isomerisation, C6-fraction; Low boiling point modified naphtha [A complex combination of hydrocarbons obtained by distillation of a gasoline which has been catalyticall isomerized. It consists predominantly of hexane isomers boiling in the range of approximately 60 °C to 66 °C (140°F to 151°F).]

A complex combination of hydrocarbons obtained by distillation of a gasoline which has been catalytically isomerized. It consists predominantly of hexane isomers boiling in the range of approximately 60°C to 66°C (140°F to 151°F). EC / List no: 295-440-5 CAS no: 92045-58-4
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1