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).

Naphtha (petroleum), light thermal cracked, sweetened; Low boiling point thermally cracked naphtha [A complex combination of hydrocarbons obtained by subjecting a petroleum distillate From the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20 °C to 100 °C (68 °F to 212 °F).]

A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20°C to 100°C (68°F to 212°F). EC / List no: 295-447-3 CAS no: 92045-65-3
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1