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).

RELEVANT LEGISLATION
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Distillates (coal tar), pitch, heavy oils; Heavy Anthracene Oil [The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri-and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300 °C to 470 °C (572 °F to 878 °F). The product may also contain heteroatoms.]

The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri- and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300°C to 470°C (572°F to 878°F). The product may also contain heteroatoms. EC / List no: 295-312-9 CAS no: 91995-51-6
EU CLP (1272/2008)
Carc. 1B