EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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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Residues (petroleum), steam-cracked; Heavy Fuel oil [A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C14 and boiling above approximately 260 °C (500 °F). This stream is likely to contain 5 wt. % or more of 4-to 6-memberedcondensed ring aromatic hydrocarbons.]

A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C14 and boiling above approximately 260°C (500°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons. EC / List no: 265-193-8 CAS no: 64742-90-1
EU CLP (1272/2008)
Carc. 1B