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).

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Distillates (coal tar), heavy oils, pyrene fraction; Heavy Anthracene Oil Redistillate [The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350 °C to 400 °C (662 °F to 752 °F). Consists predominantly of tri-and polynuclear aromatics and heterocyclic hydrocarbons.]

The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons. EC / List no: 295-304-5 CAS no: 91995-42-5
EU CLP (1272/2008)
Carc. 1B