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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Residues (coal tar), pitch distn.; Pitch Redistillate [Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752 °F to 846 °F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.]

Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752°F to 846°F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds. EC / List no: 295-507-9 CAS no: 92061-94-4
EU CLP (1272/2008)
Carc. 1B