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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Gases (petroleum), benzene unit hydrotreater depentanizer overheads; Refinery gas [A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanizing. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene.]

A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanizing. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene. EC / List no: 271-623-5 CAS no: 68602-82-4
EU CLP (1272/2008)
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B