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), catalytic reformer fractionator; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C25 and boiling in the range of approximately 160 °C to 400°C (320 °F to 725 °F). This stream is likely to contain 5 wt. % or more of 4-or 6-membered condensed ring aromatic hydrocarbons.]

A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C25 and boiling in the range of approximately 160°C to 400°C (320°F to 725°F). This stream is likely to contain 5 wt. % or more of 4- or 6-membered condensed ring aromatic hydrocarbons. EC / List no: 265-069-3 CAS no: 64741-67-9
EU CLP (1272/2008)
Carc. 1B