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).

Hydrocarbon oils, arom., mixed with polyethylene, pyrolyzed, light oil fraction; Heat Treatment Products [The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70 °C to 120 °C (158°F to 248°F).]

The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70°C to 120°C (158°F to 248°F). EC / List no: 309-748-5 CAS no: 100801-65-8
EU CLP (1272/2008)
Carc. 1B; Muta. 1B