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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Naphtha (petroleum), light steam-cracked; Low boiling point naphtha -unspecified [A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20 °C to 190 °C (- 4°F to 374°F). This stream is likely to contain 10 vol.% or more benzene.]

A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F). This stream is likely to contain 10 vol. % or more benzene. EC / List no: 265-187-5 CAS no: 64742-83-2
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1