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), pitch, pyrene fraction; Heavy Anthracene Oil Redistillate [The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380 °C to 410 °C (7160 to 770 °F). Composed primarily of tri-and polynuclear aromatic hydrocarbons and heterocyclic compounds.]

The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380°C to 410°C (716°F to 770°F). Composed primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic compounds. EC / List no: 295-313-4 CAS no: 91995-52-7
EU CLP (1272/2008)
Carc. 1B