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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Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived; Low boiling point thermally cracked naphtha [A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816 o C (1 500 °F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.]

A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene. EC / List no: 270-658-3 CAS no: 68475-70-7
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1