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 (coal tar), pitch; Heavy Anthracene Oil [The oil obtained from condensation of the vapors from the heat treatment of pitch.; Composed primarily of two-to four-ring aromatic compounds boiling in the range of 200 °C to greater than 400 °C (392 °F to greater than 752 °F).]

The oil obtained from condensation of the vapors from the heat treatment of pitch. Composed primarily of two- to four-ring aromatic compounds boiling in the range of 200°C to greater than 400°C (392°F to greater than 752°F). EC / List no: 309-855-7 CAS no: 101316-49-8
EU CLP (1272/2008)
Carc. 1B