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).

Naphtha (petroleum), light, sweetened; Low boiling point naphtha -unspecified [A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydro carbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately - 20o C to 100o C (- 4°F to 212 °F).]

A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -20°C to 100°C (-4°F to 212°F). EC / List no: 272-206-0 CAS no: 68783-66-4
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1