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).

Distillates (petroleum), C7-9, C8-rich, hydrodesulfurized dearomatized; Low boiling point naphtha -unspecified [A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120 o C to 130 o C (248 °F to 266 °F).]

A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120°C to 130°C (248°F to 266°F). EC / List no: 309-862-5 CAS no: 101316-56-7
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1